Liver Cirrhosis, Biliary
Conditions
Keywords
Primary Biliary Cholangitis, Primary Biliary Cirrhosis, PBC, Hepatic Impairment, Cirrhosis, Liver
Brief summary
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment period. Participants who have completed their 48-week double blind treatment period will continue double-blind treatment until all randomized participants have completed their 48-week treatment period and the database for that period is locked. An open-label extension study in which all participants receive OCA will be considered following review of blinded safety and PK data.
Interventions
OCA will be administered per dose and schedule specified in the arm description.
DRUGPlacebo
OCA matching placebo will be administered per the schedule specified in the arm description.
Sponsors
Intercept Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. A definite or probable diagnosis of PBC (consistent with American Association for the Study of Liver Diseases \[AASLD\] and European Association for the Study of the Liver \[EASL\] Practice Guidelines, defined as having ≥2 of the following 3 diagnostic factors: * History of elevated alkaline phosphatase (ALP) levels for at least 6 months * Positive antimitochondrial antibody (AMA) titer or if AMA negative or low titer (≤1:80), PBC specific antibodies (anti-glycoprotein 210 \[GP210\] and/or anti-SP100) and/or antibodies against the major M2 components (E2 component of mitochondrial pyruvate dehydrogenase complex \[PDC-E2\], 2-oxo-glutaric acid dehydrogenase complex) * Liver biopsy consistent with PBC (collected at any time prior to Screening) 2. Evidence of cirrhosis including at least one of the following: * Biopsy results consistent with PBC Stage 4 * Liver stiffness as assessed by Transient Elastography (TE) Median Value ≥16.9 kilopascals (kPa) * Clinical evidence in the absence of acute liver failure consistent with cirrhosis including: gastroesophageal varices, ascites, radiological evidence of cirrhosis (nodular liver or enlargement of portal vein and splenomegaly) * Combined low platelet count (\<140,000/cubic millimeter \[mm\^3\]) with * persistent decrease in serum albumin, or * elevation in prothrombin time/international normalized ratio (INR) (not due to antithrombotic agent use), or * elevated bilirubin (2\*upper limit of normal \[ULN\]) 3. Satisfy the criteria of the modified Child-Pugh (CP) classification for hepatic impairment during Screening: * Moderate: CP-B (Scores 7 to 9) or * Severe: CP-C (Scores 10 to 12) 4. Model of end-stage liver disease (MELD) score of 6 to 24 at Screening 5. Taking ursodeoxycholic acid (UDCA) for at least 12 months (stable dose for ≥3 months) prior to Day 1, or unable to tolerate or unresponsive to UDCA (no UDCA for ≥3 months)
Exclusion criteria
1. Non-cirrhotic or cirrhotic CP-A (Mild; Score 5 to 6) 2. History of liver transplant or organ transplant 3. History of alcohol or drug abuse within 12 months prior to Screening 4. Hepatic encephalopathy (as defined by a West Haven score of ≥2 5. History or presence of other concomitant liver diseases including: * Hepatitis C virus infection and ribonucleic acid (RNA) positive * Active hepatitis B infection; however, participants who have seroconverted (hepatitis B surface antigen and hepatitis B e antigen negative) may be included in this study after consultation with the medical monitor * Primary sclerosing cholangitis * Alcoholic liver disease * Definite autoimmune liver disease or overlap hepatitis * Gilbert's Syndrome 6. In the opinion of the Investigator, fluctuating or rapidly deteriorating hepatic function prior to randomization Other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to approximately 3 years | An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. An SAE was any AE that results in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in in-patient hospitalization or prolonged an existing hospitalization, was a congenital anomaly/birth defect, or was an important medical event that could jeopardize the participant or could have required medical intervention to prevent one of the outcomes listed above. TEAE was defined as any AE if it met one or more of the following criteria: 1) An AE started on or after the first study drug dose and within 30 days after the last dose of study drug, 2) An AE occurred prior to the first study drug dose that worsens (increase in grade) after the first study drug dose. |
| Ctrough of OCA-glucuronide at Week 18 | 24 hours post-dose at Week 18 | Ctrough was considered as the concentration at 24-hours post-dose at Week 18. |
| AUC0-24h of OCA-glucuronide at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of OCA-glucuronide at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of OCA-glucuronide at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration. |
| Cmax of OCA-glucuronide at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | — |
| Tmax of OCA-glucuronide at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | — |
| Ctrough of OCA-glucuronide at Week 24 | 24 hours post-dose at Week 24 | Ctrough was considered as the concentration at 24-hours post-dose at Week 24. |
| AUC0-24h of OCA-glucuronide at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of OCA-glucuronide at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of OCA-glucuronide at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration. |
| Cmax of OCA-glucuronide at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | — |
| Tmax of OCA-glucuronide at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | — |
| Ctrough of OCA-glucuronide at Week 30 | 24 hours post-dose at Week 30 | Ctrough was considered as the concentration at 24-hours post-dose at Week 30. |
| AUC0-24h of OCA-glucuronide at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of OCA-glucuronide at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of OCA-glucuronide at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration. |
| Cmax of OCA-glucuronide at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | — |
| Tmax of OCA-glucuronide at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | — |
| Ctrough of OCA-glucuronide at Week 48 | 24 hours post-dose at Week 48 | Ctrough was considered as the concentration at 24-hours post-dose at Week 48. |
| AUC0-24h of OCA-glucuronide at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of OCA-glucuronide at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of OCA-glucuronide at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration. |
| Tmax of Total OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| Maximum Observed Concentration (Cmax) of Total OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. Pharmacokinetics (PK) of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12. |
| Time to Maximum Concentration (Tmax) of Total OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| Trough Concentration (Ctrough) of Total OCA at Week 12 | 24 hours post-dose at Week 12 | Ctrough was considered as the concentration at 24-hours post-dose at Week 12. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| Ctrough of Total OCA at Week 48 | 24 hours post-dose at Week 48 | Ctrough was considered as the concentration at 24-hours post-dose at Week 48. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| Area Under the Concentration Versus Time Curve From Zero Time to 24 Hours (AUC0-24h) of Total OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| Cmax of Total OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| Tmax of Total OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| Ctrough of Total OCA at Week 18 | 24 hours post-dose at Week 18 | Ctrough was considered as the concentration at 24-hours post-dose at Week 18. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| AUC0-24h of Total OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| Cmax of Total OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| Tmax of Total OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| Ctrough of Total OCA at Week 24 | 24 hours post-dose at Week 24 | Ctrough was considered as the concentration at 24-hours post-dose at Week 24. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| AUC0-24h of Total OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| Cmax of Total OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| Tmax of Total OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| Ctrough of Total OCA at Week 30 | 24 hours post-dose at Week 30 | Ctrough was considered as the concentration at 24-hours post-dose at Week 30. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| AUC0-24h of Total OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| Cmax of Total OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. |
| AUC0-24h of Total OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| Cmax of Unconjugated OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | — |
| Tmax of Unconjugated OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | — |
| Ctrough of Unconjugated OCA at Week 12 | 24 hours post-dose at Week 12 | Ctrough was considered as the concentration at 24-hours post-dose at Week 12. |
| AUC0-24h of Unconjugated OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | AUC0-24 was calculated using the linear/linear trapezoidal rule. |
| Cmax of Unconjugated OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | — |
| Tmax of Unconjugated OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | — |
| Ctrough of Unconjugated OCA at Week 18 | 24 hours post-dose at Week 18 | Ctrough was considered as the concentration at 24-hours post-dose at Week 18. |
| AUC0-24h of Unconjugated OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| Cmax of Unconjugated OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | — |
| Tmax of Unconjugated OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | — |
| Ctrough of Unconjugated OCA at Week 24 | 24 hours post-dose at Week 24 | Ctrough was considered as the concentration at 24-hours post-dose at Week 24. |
| AUC0-24h of Unconjugated OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| Cmax of Unconjugated OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | — |
| Tmax of Unconjugated OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | — |
| Ctrough of Unconjugated OCA at Week 30 | 24 hours post-dose at Week 30 | Ctrough was considered as the concentration at 24-hours post-dose at Week 30. |
| AUC0-24h of Unconjugated OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| Cmax of Unconjugated OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | — |
| Tmax of Unconjugated OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | — |
| Ctrough of Unconjugated OCA at Week 48 | 24 hours post-dose at Week 48 | Ctrough was considered as the concentration at 24-hours post-dose at Week 48. |
| AUC0-24h of Unconjugated OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| Cmax of Glyco Conjugate of OCA (Glyco-OCA) at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | — |
| Tmax of Glyco-OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | — |
| Ctrough of Glyco-OCA at Week 12 | 24 hours post-dose at Week 12 | Ctrough was considered as the concentration at 24-hours post-dose at Week 12. |
| AUC0-24h of Glyco-OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| Metabolite to Parent Ratio of AUC-0-24h (MRAUC) of Glyco-OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| Metabolite to Parent Ratio of Cmax (MRCmax) of Glyco-OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration. |
| Cmax of Glyco-OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | — |
| Tmax of Glyco-OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | — |
| Ctrough of Glyco-OCA at Week 18 | 24 hours post-dose at Week 18 | Ctrough was considered as the concentration at 24-hours post-dose at Week 18. |
| AUC0-24h of Glyco-OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of Glyco-OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of Glyco-OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration. |
| Cmax of Glyco-OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | — |
| Tmax of Glyco-OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | — |
| Ctrough of Glyco-OCA at Week 24 | 24 hours post-dose at Week 24 | Ctrough was considered as the concentration at 24-hours post-dose at Week 24. |
| AUC0-24h of Glyco-OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of Glyco-OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of Glyco-OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration. |
| Cmax of Glyco-OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | — |
| Tmax of Glyco-OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | — |
| Ctrough of Glyco-OCA at Week 30 | 24 hours post-dose at Week 30 | Ctrough was considered as the concentration at 24-hours post-dose at Week 30. |
| AUC0-24h of Glyco-OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of Glyco-OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of Glyco-OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration. |
| Cmax of Glyco-OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | — |
| Tmax of Glyco-OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | — |
| Ctrough of Glyco-OCA at Week 48 | 24 hours post-dose at Week 48 | Ctrough was considered as the concentration at 24-hours post-dose at Week 48. |
| AUC0-24h of Glyco-OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of Glyco-OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of Glyco-OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration. |
| Cmax of Tauro Conjugate of OCA (Tauro-OCA) at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | — |
| Tmax of Tauro-OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | — |
| Ctrough of Tauro-OCA at Week 12 | 24 hours post-dose at Week 12 | Ctrough was considered as the concentration at 24-hours post-dose at Week 12. |
| AUC0-24h of Tauro-OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of Tauro-OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of Tauro-OCA at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration. |
| Cmax of Tauro-OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | — |
| Tmax of Tauro-OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | — |
| Ctrough of Tauro-OCA at Week 18 | 24 hours post-dose at Week 18 | Ctrough was considered as the concentration at 24-hours post-dose at Week 18. |
| AUC0-24h of Tauro-OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of Tauro-OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of Tauro-OCA at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration. |
| Cmax of Tauro-OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | — |
| Tmax of Tauro-OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | — |
| Ctrough of Tauro-OCA at Week 24 | 24 hours post-dose at Week 24 | Ctrough was considered as the concentration at 24-hours post-dose at Week 24. |
| AUC0-24h of Tauro-OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of Tauro-OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of Tauro-OCA at Week 24 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24 | MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration. |
| Cmax of Tauro-OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | — |
| Tmax of Tauro-OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | — |
| Ctrough of Tauro-OCA at Week 30 | 24 hours post-dose at Week 30 | Ctrough was considered as the concentration at 24-hours post-dose at Week 30. |
| AUC0-24h of Tauro-OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of Tauro-OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of Tauro-OCA at Week 30 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30 | MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration. |
| Cmax of Tauro-OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | — |
| Tmax of Tauro-OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | — |
| Ctrough of Tauro-OCA at Week 48 | 24 hours post-dose at Week 48 | Ctrough was considered as the concentration at 24-hours post-dose at Week 48. |
| AUC0-24h of Tauro-OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of Tauro-OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of Tauro-OCA at Week 48 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48 | MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration. |
| Cmax of Glucuronide Metabolite of OCA (OCA-glucuronide) at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | — |
| Tmax of OCA-glucuronide at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | — |
| Ctrough of OCA-glucuronide at Week 12 | 24 hours post-dose at Week 12 | Ctrough was considered as the concentration at 24-hours post-dose at Week 12. |
| AUC0-24h of OCA-glucuronide at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | AUC0-24h was calculated using the linear/linear trapezoidal rule. |
| MRAUC of OCA-glucuronide at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours. |
| MRCmax of OCA-glucuronide at Week 12 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12 | MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration. |
| Cmax of OCA-glucuronide at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | — |
| Tmax of OCA-glucuronide at Week 18 | Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | The MELD-Na scoring system is used to assess the severity of chronic liver disease in the participants with an initial MELD(i) score greater than 11. MELD-Na score is derived from the participant's serum total bilirubin, serum creatinine, INR, and sodium. The MELD-Na score is re-calculated as follows: MELD-Na = MELD(i) + 1.32\*(137-Na) - \[0.033\*MELD(i)\*(137-Na)\]. MELD score ranges from 6-40 with higher scores indicating more severe liver disease and a worse outcome. The MELD(i) score is derived from the participant's serum total bilirubin, serum creatinine, and prothrombin international normalized ratio (INR): 3.78×log normal (ln) \[total bilirubin (mg/deciliter \[dL\])\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43. The MELD score ranges from 6 to 40 with higher scores indicating more severe liver disease and a worse outcome. |
| Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | The Child-Pugh classification was a scoring system used for the classification of the severity of cirrhosis. It included three continuous variables (bilirubin, albumin, and INR) and two discrete variables (ascites and encephalopathy). Each variable was scored 1-3 with 3 indicating most severe derangement. The determination of Child-Pugh score ranged from 5 to 15. The higher the score, the sicker the participant. |
| Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Number of participants with Child-Pugh component - ascites categories of none, mild, and moderate-severe has been reported. The ascites categories were defined per investigator's discretion. |
| Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Number of participants with Child-Pugh component - prothrombin time (measured as INR) in categories of \<1.7, 1.7 - 2.3, and \>2.3 has been reported. |
| Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Number of participants with Child-Pugh component - serum albumin levels in categories of \>35 gram per liter (g/L), 28-35 g/L, or \<28 g/L has been reported. |
| Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Number of participants with Child-Pugh component - total bilirubin levels in categories of \<34 micromole per liter (µmol/L), 34-50 µmol/L, and \>50 µmol/L has been reported. |
| Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Number of participants with Child-Pugh component - Hepatic encephalopathy in categories of Grade 0, Grade 1 or 2, and Grade 3 and 4 has been reported. Grade 0: normal consciousness, normal personality, normal neurological examination, normal electroencephalogram. Grade 1: restless, sleep disturbed, irritable/agitated, tremor, impaired handwriting, 5 cycles, per second (cps) waves. Grade 2: lethargic, time-disoriented, inappropriate, asterixis, ataxia, slow triphasic waves. Grade 3: somnolent, stuporous, place-disoriented, hyperactive reflexes, rigidity, slower waves. Grade 4: unrousable coma, no personality/behavior, decerebrate, slow 2-3 cps delta activity. |
| Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | — |
| Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | — |
| Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | — |
| Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | — |
| Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | — |
| Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | — |
| Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | — |
| Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | — |
| Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | — |
| Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | — |
| Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Total bile acids (micromole \[μM\]) = total ursodeoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total chenodeoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total deoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total cholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total lithocholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM. |
| Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Total endogenous bile acids (μM) = total chenodeoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total deoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total cholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total lithocholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM. |
| Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | — |
| Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | — |
| Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | The MELD scoring system is used to assess the severity of chronic liver disease. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and prothrombin international normalized ratio (INR): 3.78×log normal (ln) \[total bilirubin (mg/deciliter \[dL\])\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43. The MELD score ranges from 6 to 40 with higher scores indicating more severe liver disease and a worse outcome. |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Estonia, Germany, Hungary, Italy, Lithuania, Spain, United States
Participant flow
Recruitment details
This study was conducted at study sites in the United States, Argentina, Belgium, Spain, Lithuania, Brazil, Australia, Germany, Estonia, Italy, Hungary, and Canada.
Pre-assignment details
A total of 31 participants were screened and 22 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years). | 12 |
| Obeticholic Acid (OCA) Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years). | 10 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| DB Extension, Week 48 up to 3 Years | Death | 0 | 1 |
| DB Extension, Week 48 up to 3 Years | Lost to Follow-up | 1 | 0 |
| DB Extension, Week 48 up to 3 Years | Physician Decision | 0 | 1 |
| DB Extension, Week 48 up to 3 Years | Study Terminated by Sponsor | 3 | 2 |
| DB Extension, Week 48 up to 3 Years | Withdrawal by Subject | 0 | 2 |
| Double Blind (DB), up to Week 48 | Adverse Event | 0 | 1 |
| Double Blind (DB), up to Week 48 | Death | 2 | 1 |
| Double Blind (DB), up to Week 48 | Liver Transplant During the Course of the Study | 1 | 0 |
| Double Blind (DB), up to Week 48 | Multiple Serious Adverse Events and Drug Interruptions | 1 | 0 |
| Double Blind (DB), up to Week 48 | Physician Decision | 1 | 0 |
| Double Blind (DB), up to Week 48 | Study Terminated by Sponsor | 2 | 1 |
| Double Blind (DB), up to Week 48 | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Obeticholic Acid (OCA) | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 10.19 | 61.6 years STANDARD_DEVIATION 9.43 | 62.5 years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 12 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 21 Participants | 11 Participants |
| Sex: Female, Male Female | 6 Participants | 16 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 12 | 2 / 10 |
| other Total, other adverse events | 10 / 12 | 10 / 10 |
| serious Total, serious adverse events | 9 / 12 | 7 / 10 |
Outcome results
Primary
Area Under the Concentration Versus Time Curve From Zero Time to 24 Hours (AUC0-24h) of Total OCA at Week 12
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Area Under the Concentration Versus Time Curve From Zero Time to 24 Hours (AUC0-24h) of Total OCA at Week 12 | 2970 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 1650 |
Primary
AUC0-24h of Glyco-OCA at Week 12
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Glyco-OCA at Week 12 | 1690 ng*h/mL | Standard Deviation 947 |
Primary
AUC0-24h of Glyco-OCA at Week 18
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Glyco-OCA at Week 18 | 625 ng*h/mL | Standard Deviation 147 |
| OCA 5 mg Twice Weekly | AUC0-24h of Glyco-OCA at Week 18 | 3020 ng*h/mL | Standard Deviation 1120 |
Primary
AUC0-24h of Glyco-OCA at Week 24
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Glyco-OCA at Week 24 | 2710 ng*h/mL | Standard Deviation 3030 |
| OCA 5 mg Twice Weekly | AUC0-24h of Glyco-OCA at Week 24 | 936 ng*h/mL | — |
| OCA 10 mg Twice Weekly | AUC0-24h of Glyco-OCA at Week 24 | 5550 ng*h/mL | Standard Deviation 878 |
Primary
AUC0-24h of Glyco-OCA at Week 30
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Glyco-OCA at Week 30 | 863 ng*h/mL | — |
| OCA 5 mg Twice Weekly | AUC0-24h of Glyco-OCA at Week 30 | 3180 ng*h/mL | Standard Deviation 1080 |
| OCA 10 mg Twice Weekly | AUC0-24h of Glyco-OCA at Week 30 | 5050 ng*h/mL | Standard Deviation 2260 |
Primary
AUC0-24h of Glyco-OCA at Week 48
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | AUC0-24h of Glyco-OCA at Week 48 | 2120 ng*h/mL | Standard Deviation 422 |
| OCA 10 mg Twice Weekly | AUC0-24h of Glyco-OCA at Week 48 | 6950 ng*h/mL | Standard Deviation 648 |
Primary
AUC0-24h of OCA-glucuronide at Week 12
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of OCA-glucuronide at Week 12 | 593 ng*h/mL | Standard Deviation 388 |
Primary
AUC0-24h of OCA-glucuronide at Week 18
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of OCA-glucuronide at Week 18 | 390 ng*h/mL | Standard Deviation 278 |
| OCA 5 mg Twice Weekly | AUC0-24h of OCA-glucuronide at Week 18 | 1120 ng*h/mL | Standard Deviation 989 |
Primary
AUC0-24h of OCA-glucuronide at Week 24
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of OCA-glucuronide at Week 24 | 330 ng*h/mL | Standard Deviation 191 |
| OCA 5 mg Twice Weekly | AUC0-24h of OCA-glucuronide at Week 24 | 602 ng*h/mL | — |
| OCA 10 mg Twice Weekly | AUC0-24h of OCA-glucuronide at Week 24 | 2120 ng*h/mL | Standard Deviation 1920 |
Primary
AUC0-24h of OCA-glucuronide at Week 30
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of OCA-glucuronide at Week 30 | 170 ng*h/mL | — |
| OCA 5 mg Twice Weekly | AUC0-24h of OCA-glucuronide at Week 30 | 641 ng*h/mL | Standard Deviation 482 |
| OCA 10 mg Twice Weekly | AUC0-24h of OCA-glucuronide at Week 30 | 2200 ng*h/mL | Standard Deviation 2100 |
Primary
AUC0-24h of OCA-glucuronide at Week 48
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | AUC0-24h of OCA-glucuronide at Week 48 | 952 ng*h/mL | Standard Deviation 833 |
| OCA 10 mg Twice Weekly | AUC0-24h of OCA-glucuronide at Week 48 | 2490 ng*h/mL | Standard Deviation 1520 |
Primary
AUC0-24h of Tauro-OCA at Week 12
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Tauro-OCA at Week 12 | 1580 ng*h/mL | Standard Deviation 1260 |
Primary
AUC0-24h of Tauro-OCA at Week 18
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Tauro-OCA at Week 18 | 799 ng*h/mL | Standard Deviation 654 |
| OCA 5 mg Twice Weekly | AUC0-24h of Tauro-OCA at Week 18 | 3630 ng*h/mL | Standard Deviation 3600 |
Primary
AUC0-24h of Tauro-OCA at Week 24
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Tauro-OCA at Week 24 | 2360 ng*h/mL | Standard Deviation 2650 |
| OCA 5 mg Twice Weekly | AUC0-24h of Tauro-OCA at Week 24 | 1060 ng*h/mL | — |
| OCA 10 mg Twice Weekly | AUC0-24h of Tauro-OCA at Week 24 | 7470 ng*h/mL | Standard Deviation 3260 |
Primary
AUC0-24h of Tauro-OCA at Week 30
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Tauro-OCA at Week 30 | 408 ng*h/mL | — |
| OCA 5 mg Twice Weekly | AUC0-24h of Tauro-OCA at Week 30 | 2430 ng*h/mL | Standard Deviation 18.1 |
| OCA 10 mg Twice Weekly | AUC0-24h of Tauro-OCA at Week 30 | 7020 ng*h/mL | Standard Deviation 6780 |
Primary
AUC0-24h of Tauro-OCA at Week 48
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | AUC0-24h of Tauro-OCA at Week 48 | 1220 ng*h/mL | Standard Deviation 389 |
| OCA 10 mg Twice Weekly | AUC0-24h of Tauro-OCA at Week 48 | 8890 ng*h/mL | Standard Deviation 696 |
Primary
AUC0-24h of Total OCA at Week 18
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Total OCA at Week 18 | 1380 ng*h/mL | Standard Deviation 776 |
| OCA 5 mg Twice Weekly | AUC0-24h of Total OCA at Week 18 | 5810 ng*h/mL | Standard Deviation 3600 |
Primary
AUC0-24h of Total OCA at Week 24
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Total OCA at Week 24 | 4500 ng*h/mL | Standard Deviation 4910 |
| OCA 5 mg Twice Weekly | AUC0-24h of Total OCA at Week 24 | 2020 ng*h/mL | — |
| OCA 10 mg Twice Weekly | AUC0-24h of Total OCA at Week 24 | 11300 ng*h/mL | Standard Deviation 2950 |
Primary
AUC0-24h of Total OCA at Week 30
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Total OCA at Week 30 | 1260 ng*h/mL | — |
| OCA 5 mg Twice Weekly | AUC0-24h of Total OCA at Week 30 | 5040 ng*h/mL | Standard Deviation 855 |
| OCA 10 mg Twice Weekly | AUC0-24h of Total OCA at Week 30 | 10500 ng*h/mL | Standard Deviation 7000 |
Primary
AUC0-24h of Total OCA at Week 48
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | AUC0-24h of Total OCA at Week 48 | 3210 ng*h/mL | Standard Deviation 56.7 |
| OCA 10 mg Twice Weekly | AUC0-24h of Total OCA at Week 48 | 13900 ng*h/mL | Standard Deviation 452 |
Primary
AUC0-24h of Unconjugated OCA at Week 12
AUC0-24 was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Unconjugated OCA at Week 12 | 278 ng*h/mL | Standard Deviation 142 |
Primary
AUC0-24h of Unconjugated OCA at Week 18
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Unconjugated OCA at Week 18 | 191 ng*h/mL | Standard Deviation 125 |
| OCA 5 mg Twice Weekly | AUC0-24h of Unconjugated OCA at Week 18 | 263 ng*h/mL | Standard Deviation 247 |
Primary
AUC0-24h of Unconjugated OCA at Week 24
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Unconjugated OCA at Week 24 | 235 ng*h/mL | Standard Deviation 130 |
| OCA 5 mg Twice Weekly | AUC0-24h of Unconjugated OCA at Week 24 | 345 ng*h/mL | — |
| OCA 10 mg Twice Weekly | AUC0-24h of Unconjugated OCA at Week 24 | 480 ng*h/mL | Standard Deviation 414 |
Primary
AUC0-24h of Unconjugated OCA at Week 30
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | AUC0-24h of Unconjugated OCA at Week 30 | 176 ng*h/mL | — |
| OCA 5 mg Twice Weekly | AUC0-24h of Unconjugated OCA at Week 30 | 304 ng*h/mL | Standard Deviation 82.3 |
| OCA 10 mg Twice Weekly | AUC0-24h of Unconjugated OCA at Week 30 | 473 ng*h/mL | Standard Deviation 397 |
Primary
AUC0-24h of Unconjugated OCA at Week 48
AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | AUC0-24h of Unconjugated OCA at Week 48 | 376 ng*h/mL | Standard Deviation 118 |
| OCA 10 mg Twice Weekly | AUC0-24h of Unconjugated OCA at Week 48 | 1190 ng*h/mL | — |
Primary
Cmax of Glucuronide Metabolite of OCA (OCA-glucuronide) at Week 12
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Glucuronide Metabolite of OCA (OCA-glucuronide) at Week 12 | 47.0 ng/mL | Standard Deviation 24.7 |
Primary
Cmax of Glyco Conjugate of OCA (Glyco-OCA) at Week 12
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Glyco Conjugate of OCA (Glyco-OCA) at Week 12 | 117 ng/mL | Standard Deviation 55 |
Primary
Cmax of Glyco-OCA at Week 18
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Glyco-OCA at Week 18 | 52.7 ng/mL | Standard Deviation 4.31 |
| OCA 5 mg Twice Weekly | Cmax of Glyco-OCA at Week 18 | 213 ng/mL | Standard Deviation 22.6 |
Primary
Cmax of Glyco-OCA at Week 24
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Glyco-OCA at Week 24 | 166 ng/mL | Standard Deviation 163 |
| OCA 5 mg Twice Weekly | Cmax of Glyco-OCA at Week 24 | 56.2 ng/mL | — |
| OCA 10 mg Twice Weekly | Cmax of Glyco-OCA at Week 24 | 294 ng/mL | Standard Deviation 70 |
Primary
Cmax of Glyco-OCA at Week 30
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Glyco-OCA at Week 30 | 83.0 ng/mL | — |
| OCA 5 mg Twice Weekly | Cmax of Glyco-OCA at Week 30 | 174 ng/mL | Standard Deviation 75 |
| OCA 10 mg Twice Weekly | Cmax of Glyco-OCA at Week 30 | 301 ng/mL | Standard Deviation 86.3 |
Primary
Cmax of Glyco-OCA at Week 48
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | Cmax of Glyco-OCA at Week 48 | 123 ng/mL | Standard Deviation 34 |
| OCA 10 mg Twice Weekly | Cmax of Glyco-OCA at Week 48 | 354 ng/mL | Standard Deviation 37.5 |
Primary
Cmax of OCA-glucuronide at Week 18
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of OCA-glucuronide at Week 18 | 39.2 ng/mL | Standard Deviation 30.3 |
| OCA 5 mg Twice Weekly | Cmax of OCA-glucuronide at Week 18 | 74.9 ng/mL | Standard Deviation 38.4 |
Primary
Cmax of OCA-glucuronide at Week 24
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of OCA-glucuronide at Week 24 | 20.2 ng/mL | Standard Deviation 7.42 |
| OCA 5 mg Twice Weekly | Cmax of OCA-glucuronide at Week 24 | 58.1 ng/mL | — |
| OCA 10 mg Twice Weekly | Cmax of OCA-glucuronide at Week 24 | 127 ng/mL | Standard Deviation 71 |
Primary
Cmax of OCA-glucuronide at Week 30
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of OCA-glucuronide at Week 30 | 13.7 ng/mL | — |
| OCA 5 mg Twice Weekly | Cmax of OCA-glucuronide at Week 30 | 51.9 ng/mL | Standard Deviation 49.4 |
| OCA 10 mg Twice Weekly | Cmax of OCA-glucuronide at Week 30 | 148 ng/mL | Standard Deviation 117 |
Primary
Cmax of OCA-glucuronide at Week 48
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | Cmax of OCA-glucuronide at Week 48 | 66.0 ng/mL | Standard Deviation 63.6 |
| OCA 10 mg Twice Weekly | Cmax of OCA-glucuronide at Week 48 | 134 ng/mL | Standard Deviation 71.3 |
Primary
Cmax of Tauro Conjugate of OCA (Tauro-OCA) at Week 12
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Tauro Conjugate of OCA (Tauro-OCA) at Week 12 | 201 ng/mL | Standard Deviation 213 |
Primary
Cmax of Tauro-OCA at Week 18
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Tauro-OCA at Week 18 | 63.2 ng/mL | Standard Deviation 46.9 |
| OCA 5 mg Twice Weekly | Cmax of Tauro-OCA at Week 18 | 221 ng/mL | Standard Deviation 188 |
Primary
Cmax of Tauro-OCA at Week 24
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Tauro-OCA at Week 24 | 142 ng/mL | Standard Deviation 144 |
| OCA 5 mg Twice Weekly | Cmax of Tauro-OCA at Week 24 | 65.5 ng/mL | — |
| OCA 10 mg Twice Weekly | Cmax of Tauro-OCA at Week 24 | 430 ng/mL | Standard Deviation 142 |
Primary
Cmax of Tauro-OCA at Week 30
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Tauro-OCA at Week 30 | 38.6 ng/mL | — |
| OCA 5 mg Twice Weekly | Cmax of Tauro-OCA at Week 30 | 141 ng/mL | Standard Deviation 13.4 |
| OCA 10 mg Twice Weekly | Cmax of Tauro-OCA at Week 30 | 460 ng/mL | Standard Deviation 342 |
Primary
Cmax of Tauro-OCA at Week 48
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | Cmax of Tauro-OCA at Week 48 | 72.5 ng/mL | Standard Deviation 15.1 |
| OCA 10 mg Twice Weekly | Cmax of Tauro-OCA at Week 48 | 485 ng/mL | Standard Deviation 20.5 |
Primary
Cmax of Total OCA at Week 18
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Total OCA at Week 18 | 136 ng/mL | Standard Deviation 77.6 |
| OCA 5 mg Twice Weekly | Cmax of Total OCA at Week 18 | 406 ng/mL | Standard Deviation 120 |
Primary
Cmax of Total OCA at Week 24
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Total OCA at Week 24 | 263 ng/mL | Standard Deviation 261 |
| OCA 5 mg Twice Weekly | Cmax of Total OCA at Week 24 | 195 ng/mL | — |
| OCA 10 mg Twice Weekly | Cmax of Total OCA at Week 24 | 622 ng/mL | Standard Deviation 117 |
Primary
Cmax of Total OCA at Week 30
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Total OCA at Week 30 | 125 ng/mL | — |
| OCA 5 mg Twice Weekly | Cmax of Total OCA at Week 30 | 277 ng/mL | Standard Deviation 64.7 |
| OCA 10 mg Twice Weekly | Cmax of Total OCA at Week 30 | 674 ng/mL | Standard Deviation 310 |
Primary
Cmax of Total OCA at Week 48
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | Cmax of Total OCA at Week 48 | 200 ng/mL | Standard Deviation 15.1 |
| OCA 10 mg Twice Weekly | Cmax of Total OCA at Week 48 | 728 ng/mL | Standard Deviation 27.5 |
Primary
Cmax of Unconjugated OCA at Week 12
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Unconjugated OCA at Week 12 | 107 ng/mL | Standard Deviation 62 |
Primary
Cmax of Unconjugated OCA at Week 18
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Unconjugated OCA at Week 18 | 107 ng/mL | Standard Deviation 47.4 |
| OCA 5 mg Twice Weekly | Cmax of Unconjugated OCA at Week 18 | 109 ng/mL | Standard Deviation 90.3 |
Primary
Cmax of Unconjugated OCA at Week 24
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Unconjugated OCA at Week 24 | 115 ng/mL | Standard Deviation 98.2 |
| OCA 5 mg Twice Weekly | Cmax of Unconjugated OCA at Week 24 | 157 ng/mL | — |
| OCA 10 mg Twice Weekly | Cmax of Unconjugated OCA at Week 24 | 168 ng/mL | Standard Deviation 92.6 |
Primary
Cmax of Unconjugated OCA at Week 30
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Cmax of Unconjugated OCA at Week 30 | 92.6 ng/mL | — |
| OCA 5 mg Twice Weekly | Cmax of Unconjugated OCA at Week 30 | 132 ng/mL | Standard Deviation 24 |
| OCA 10 mg Twice Weekly | Cmax of Unconjugated OCA at Week 30 | 115 ng/mL | Standard Deviation 40.9 |
Primary
Cmax of Unconjugated OCA at Week 48
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | Cmax of Unconjugated OCA at Week 48 | 131 ng/mL | Standard Deviation 31.8 |
| OCA 10 mg Twice Weekly | Cmax of Unconjugated OCA at Week 48 | 284 ng/mL | Standard Deviation 177 |
Primary
Ctrough of Glyco-OCA at Week 12
Ctrough was considered as the concentration at 24-hours post-dose at Week 12.
Time frame: 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Glyco-OCA at Week 12 | 47.1 ng/mL | Standard Deviation 31.1 |
Primary
Ctrough of Glyco-OCA at Week 18
Ctrough was considered as the concentration at 24-hours post-dose at Week 18.
Time frame: 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Glyco-OCA at Week 18 | 13.3 ng/mL | Standard Deviation 5.03 |
| OCA 5 mg Twice Weekly | Ctrough of Glyco-OCA at Week 18 | 98.1 ng/mL | Standard Deviation 53.7 |
Primary
Ctrough of Glyco-OCA at Week 24
Ctrough was considered as the concentration at 24-hours post-dose at Week 24.
Time frame: 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Glyco-OCA at Week 24 | 83.0 ng/mL | Standard Deviation 106 |
| OCA 5 mg Twice Weekly | Ctrough of Glyco-OCA at Week 24 | 22.0 ng/mL | — |
| OCA 10 mg Twice Weekly | Ctrough of Glyco-OCA at Week 24 | 239 ng/mL | Standard Deviation 7.07 |
Primary
Ctrough of Glyco-OCA at Week 30
Ctrough was considered as the concentration at 24-hours post-dose at Week 30.
Time frame: 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Glyco-OCA at Week 30 | 14.4 ng/mL | — |
| OCA 5 mg Twice Weekly | Ctrough of Glyco-OCA at Week 30 | 143 ng/mL | Standard Deviation 30.4 |
| OCA 10 mg Twice Weekly | Ctrough of Glyco-OCA at Week 30 | 156 ng/mL | Standard Deviation 79.4 |
Primary
Ctrough of Glyco-OCA at Week 48
Ctrough was considered as the concentration at 24-hours post-dose at Week 48.
Time frame: 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | Ctrough of Glyco-OCA at Week 48 | 65.9 ng/mL | Standard Deviation 10.2 |
| OCA 10 mg Twice Weekly | Ctrough of Glyco-OCA at Week 48 | 280 ng/mL | Standard Deviation 62.2 |
Primary
Ctrough of OCA-glucuronide at Week 12
Ctrough was considered as the concentration at 24-hours post-dose at Week 12.
Time frame: 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of OCA-glucuronide at Week 12 | 20.7 ng/mL | Standard Deviation 15.4 |
Primary
Ctrough of OCA-glucuronide at Week 18
Ctrough was considered as the concentration at 24-hours post-dose at Week 18.
Time frame: 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of OCA-glucuronide at Week 18 | 11.7 ng/mL | Standard Deviation 7.55 |
| OCA 5 mg Twice Weekly | Ctrough of OCA-glucuronide at Week 18 | 40.9 ng/mL | Standard Deviation 43.9 |
Primary
Ctrough of OCA-glucuronide at Week 24
Ctrough was considered as the concentration at 24-hours post-dose at Week 24.
Time frame: 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of OCA-glucuronide at Week 24 | 11.6 ng/mL | Standard Deviation 6.43 |
| OCA 5 mg Twice Weekly | Ctrough of OCA-glucuronide at Week 24 | 14.5 ng/mL | — |
| OCA 10 mg Twice Weekly | Ctrough of OCA-glucuronide at Week 24 | 84.2 ng/mL | Standard Deviation 81.7 |
Primary
Ctrough of OCA-glucuronide at Week 30
Ctrough was considered as the concentration at 24-hours post-dose at Week 30.
Time frame: 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of OCA-glucuronide at Week 30 | 5.57 ng/mL | — |
| OCA 5 mg Twice Weekly | Ctrough of OCA-glucuronide at Week 30 | 19.7 ng/mL | Standard Deviation 13.8 |
| OCA 10 mg Twice Weekly | Ctrough of OCA-glucuronide at Week 30 | 89.0 ng/mL | Standard Deviation 107 |
Primary
Ctrough of OCA-glucuronide at Week 48
Ctrough was considered as the concentration at 24-hours post-dose at Week 48.
Time frame: 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | Ctrough of OCA-glucuronide at Week 48 | 39.2 ng/mL | Standard Deviation 35.7 |
| OCA 10 mg Twice Weekly | Ctrough of OCA-glucuronide at Week 48 | 89.2 ng/mL | Standard Deviation 73.3 |
Primary
Ctrough of Tauro-OCA at Week 12
Ctrough was considered as the concentration at 24-hours post-dose at Week 12.
Time frame: 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Tauro-OCA at Week 12 | 41.6 ng/mL | Standard Deviation 33 |
Primary
Ctrough of Tauro-OCA at Week 18
Ctrough was considered as the concentration at 24-hours post-dose at Week 18.
Time frame: 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Tauro-OCA at Week 18 | 17.0 ng/mL | Standard Deviation 11.2 |
| OCA 5 mg Twice Weekly | Ctrough of Tauro-OCA at Week 18 | 122 ng/mL | Standard Deviation 130 |
Primary
Ctrough of Tauro-OCA at Week 24
Ctrough was considered as the concentration at 24-hours post-dose at Week 24.
Time frame: 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Tauro-OCA at Week 24 | 71.0 ng/mL | Standard Deviation 90.5 |
| OCA 5 mg Twice Weekly | Ctrough of Tauro-OCA at Week 24 | 21.2 ng/mL | — |
| OCA 10 mg Twice Weekly | Ctrough of Tauro-OCA at Week 24 | 271 ng/mL | Standard Deviation 58 |
Primary
Ctrough of Tauro-OCA at Week 30
Ctrough was considered as the concentration at 24-hours post-dose at Week 30.
Time frame: 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Tauro-OCA at Week 30 | 8.21 ng/mL | — |
| OCA 5 mg Twice Weekly | Ctrough of Tauro-OCA at Week 30 | 110 ng/mL | Standard Deviation 7.78 |
| OCA 10 mg Twice Weekly | Ctrough of Tauro-OCA at Week 30 | 222 ng/mL | Standard Deviation 228 |
Primary
Ctrough of Tauro-OCA at Week 48
Ctrough was considered as the concentration at 24-hours post-dose at Week 48.
Time frame: 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | Ctrough of Tauro-OCA at Week 48 | 33.7 ng/mL | Standard Deviation 21.4 |
| OCA 10 mg Twice Weekly | Ctrough of Tauro-OCA at Week 48 | 309 ng/mL | Standard Deviation 109 |
Primary
Ctrough of Total OCA at Week 18
Ctrough was considered as the concentration at 24-hours post-dose at Week 18. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Total OCA at Week 18 | 28.7 ng/mL | Standard Deviation 13.6 |
| OCA 5 mg Twice Weekly | Ctrough of Total OCA at Week 18 | 187 ng/mL | Standard Deviation 147 |
Primary
Ctrough of Total OCA at Week 24
Ctrough was considered as the concentration at 24-hours post-dose at Week 24. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Total OCA at Week 24 | 132 ng/mL | Standard Deviation 163 |
| OCA 5 mg Twice Weekly | Ctrough of Total OCA at Week 24 | 41.4 ng/mL | — |
| OCA 10 mg Twice Weekly | Ctrough of Total OCA at Week 24 | 435 ng/mL | Standard Deviation 28.6 |
Primary
Ctrough of Total OCA at Week 30
Ctrough was considered as the concentration at 24-hours post-dose at Week 30. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Total OCA at Week 30 | 22.3 ng/mL | — |
| OCA 5 mg Twice Weekly | Ctrough of Total OCA at Week 30 | 217 ng/mL | Standard Deviation 15.7 |
| OCA 10 mg Twice Weekly | Ctrough of Total OCA at Week 30 | 317 ng/mL | Standard Deviation 248 |
Primary
Ctrough of Total OCA at Week 48
Ctrough was considered as the concentration at 24-hours post-dose at Week 48. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | Ctrough of Total OCA at Week 48 | 88.3 ng/mL | Standard Deviation 29.9 |
| OCA 10 mg Twice Weekly | Ctrough of Total OCA at Week 48 | 497 ng/mL | Standard Deviation 135 |
Primary
Ctrough of Unconjugated OCA at Week 12
Ctrough was considered as the concentration at 24-hours post-dose at Week 12.
Time frame: 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Unconjugated OCA at Week 12 | 2.92 ng/mL | Standard Deviation 2.51 |
Primary
Ctrough of Unconjugated OCA at Week 18
Ctrough was considered as the concentration at 24-hours post-dose at Week 18.
Time frame: 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Unconjugated OCA at Week 18 | 3.38 ng/mL | Standard Deviation 0.262 |
| OCA 5 mg Twice Weekly | Ctrough of Unconjugated OCA at Week 18 | 3.56 ng/mL | Standard Deviation 4.01 |
Primary
Ctrough of Unconjugated OCA at Week 24
Ctrough was considered as the concentration at 24-hours post-dose at Week 24.
Time frame: 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Unconjugated OCA at Week 24 | 2.46 ng/mL | Standard Deviation 2.05 |
| OCA 5 mg Twice Weekly | Ctrough of Unconjugated OCA at Week 24 | 5.18 ng/mL | — |
| OCA 10 mg Twice Weekly | Ctrough of Unconjugated OCA at Week 24 | 8.77 ng/mL | Standard Deviation 11.4 |
Primary
Ctrough of Unconjugated OCA at Week 30
Ctrough was considered as the concentration at 24-hours post-dose at Week 30.
Time frame: 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Ctrough of Unconjugated OCA at Week 30 | 3.03 ng/mL | — |
| OCA 5 mg Twice Weekly | Ctrough of Unconjugated OCA at Week 30 | 4.27 ng/mL | Standard Deviation 4.85 |
| OCA 10 mg Twice Weekly | Ctrough of Unconjugated OCA at Week 30 | 3.20 ng/mL | Standard Deviation 3.14 |
Primary
Ctrough of Unconjugated OCA at Week 48
Ctrough was considered as the concentration at 24-hours post-dose at Week 48.
Time frame: 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | Ctrough of Unconjugated OCA at Week 48 | 3.43 ng/mL | Standard Deviation 3.9 |
| OCA 10 mg Twice Weekly | Ctrough of Unconjugated OCA at Week 48 | 4.72 ng/mL | Standard Deviation 6.67 |
Primary
Maximum Observed Concentration (Cmax) of Total OCA at Week 12
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. Pharmacokinetics (PK) of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: PK Population: participants who received OCA and had adequate concentration-time profile to characterize OCA and its conjugates and must not have had any major protocol deviations that potentially affect exposure level. Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. No participant started OCA 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Maximum Observed Concentration (Cmax) of Total OCA at Week 12 | 293 nanogram per milliliter (ng/mL) | Standard Deviation 189 |
Primary
Metabolite to Parent Ratio of AUC-0-24h (MRAUC) of Glyco-OCA at Week 12
MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Metabolite to Parent Ratio of AUC-0-24h (MRAUC) of Glyco-OCA at Week 12 | 4.36 ratio | Standard Deviation 1.03 |
Primary
Metabolite to Parent Ratio of Cmax (MRCmax) of Glyco-OCA at Week 12
MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Metabolite to Parent Ratio of Cmax (MRCmax) of Glyco-OCA at Week 12 | 1.39 ratio | Standard Deviation 1.38 |
Primary
MRAUC of Glyco-OCA at Week 18
MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRAUC of Glyco-OCA at Week 18 | 3.39 ratio | Standard Deviation 1.55 |
| OCA 5 mg Twice Weekly | MRAUC of Glyco-OCA at Week 18 | 21.2 ratio | Standard Deviation 23.6 |
Primary
MRAUC of Glyco-OCA at Week 24
MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRAUC of Glyco-OCA at Week 24 | 8.26 ratio | Standard Deviation 6.8 |
| OCA 5 mg Twice Weekly | MRAUC of Glyco-OCA at Week 24 | 2.39 ratio | — |
| OCA 10 mg Twice Weekly | MRAUC of Glyco-OCA at Week 24 | 17.3 ratio | Standard Deviation 16.5 |
Primary
MRAUC of Glyco-OCA at Week 30
MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRAUC of Glyco-OCA at Week 30 | 4.31 ratio | — |
| OCA 5 mg Twice Weekly | MRAUC of Glyco-OCA at Week 30 | 10.0 ratio | Standard Deviation 5.84 |
| OCA 10 mg Twice Weekly | MRAUC of Glyco-OCA at Week 30 | 17.2 ratio | Standard Deviation 18.7 |
Primary
MRAUC of Glyco-OCA at Week 48
MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | MRAUC of Glyco-OCA at Week 48 | 5.39 ratio | Standard Deviation 2.69 |
| OCA 10 mg Twice Weekly | MRAUC of Glyco-OCA at Week 48 | 4.79 ratio | — |
Primary
MRAUC of OCA-glucuronide at Week 12
MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRAUC of OCA-glucuronide at Week 12 | 1.17 ratio | Standard Deviation 0.638 |
Primary
MRAUC of OCA-glucuronide at Week 18
MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRAUC of OCA-glucuronide at Week 18 | 1.41 ratio | Standard Deviation 0.101 |
| OCA 5 mg Twice Weekly | MRAUC of OCA-glucuronide at Week 18 | 7.58 ratio | Standard Deviation 9.76 |
Primary
MRAUC of OCA-glucuronide at Week 24
MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRAUC of OCA-glucuronide at Week 24 | 0.983 ratio | Standard Deviation 0.0286 |
| OCA 5 mg Twice Weekly | MRAUC of OCA-glucuronide at Week 24 | 1.23 ratio | — |
| OCA 10 mg Twice Weekly | MRAUC of OCA-glucuronide at Week 24 | 6.87 ratio | Standard Deviation 8.74 |
Primary
MRAUC of OCA-glucuronide at Week 30
MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRAUC of OCA-glucuronide at Week 30 | 0.680 ratio | — |
| OCA 5 mg Twice Weekly | MRAUC of OCA-glucuronide at Week 30 | 1.39 ratio | Standard Deviation 0.742 |
| OCA 10 mg Twice Weekly | MRAUC of OCA-glucuronide at Week 30 | 7.10 ratio | Standard Deviation 9.09 |
Primary
MRAUC of OCA-glucuronide at Week 48
MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | MRAUC of OCA-glucuronide at Week 48 | 1.62 ratio | Standard Deviation 1.05 |
| OCA 10 mg Twice Weekly | MRAUC of OCA-glucuronide at Week 48 | 0.833 ratio | — |
Primary
MRAUC of Tauro-OCA at Week 12
MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRAUC of Tauro-OCA at Week 12 | 3.13 ratio | Standard Deviation 1.08 |
Primary
MRAUC of Tauro-OCA at Week 18
MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRAUC of Tauro-OCA at Week 18 | 3.11 ratio | Standard Deviation 0.685 |
| OCA 5 mg Twice Weekly | MRAUC of Tauro-OCA at Week 18 | 28.8 ratio | Standard Deviation 37.9 |
Primary
MRAUC of Tauro-OCA at Week 24
MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRAUC of Tauro-OCA at Week 24 | 6.51 ratio | Standard Deviation 5.4 |
| OCA 5 mg Twice Weekly | MRAUC of Tauro-OCA at Week 24 | 2.46 ratio | — |
| OCA 10 mg Twice Weekly | MRAUC of Tauro-OCA at Week 24 | 23.4 ratio | Standard Deviation 25.6 |
Primary
MRAUC of Tauro-OCA at Week 30
MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRAUC of Tauro-OCA at Week 30 | 1.84 ratio | — |
| OCA 5 mg Twice Weekly | MRAUC of Tauro-OCA at Week 30 | 6.61 ratio | Standard Deviation 1.74 |
| OCA 10 mg Twice Weekly | MRAUC of Tauro-OCA at Week 30 | 25.7 ratio | Standard Deviation 33 |
Primary
MRAUC of Tauro-OCA at Week 48
MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | MRAUC of Tauro-OCA at Week 48 | 2.59 ratio | Standard Deviation 0.00903 |
| OCA 10 mg Twice Weekly | MRAUC of Tauro-OCA at Week 48 | 5.60 ratio | — |
Primary
MRCmax of Glyco-OCA at Week 18
MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRCmax of Glyco-OCA at Week 18 | 0.487 ratio | Standard Deviation 0.25 |
| OCA 5 mg Twice Weekly | MRCmax of Glyco-OCA at Week 18 | 2.73 ratio | Standard Deviation 2.44 |
Primary
MRCmax of Glyco-OCA at Week 24
MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRCmax of Glyco-OCA at Week 24 | 1.17 ratio | Standard Deviation 0.253 |
| OCA 5 mg Twice Weekly | MRCmax of Glyco-OCA at Week 24 | 0.315 ratio | — |
| OCA 10 mg Twice Weekly | MRCmax of Glyco-OCA at Week 24 | 1.94 ratio | Standard Deviation 1.44 |
Primary
MRCmax of Glyco-OCA at Week 30
MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRCmax of Glyco-OCA at Week 30 | 0.789 ratio | — |
| OCA 5 mg Twice Weekly | MRCmax of Glyco-OCA at Week 30 | 1.23 ratio | Standard Deviation 0.723 |
| OCA 10 mg Twice Weekly | MRCmax of Glyco-OCA at Week 30 | 2.58 ratio | Standard Deviation 1.58 |
Primary
MRCmax of Glyco-OCA at Week 48
MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | MRCmax of Glyco-OCA at Week 48 | 0.826 ratio | Standard Deviation 0.028 |
| OCA 10 mg Twice Weekly | MRCmax of Glyco-OCA at Week 48 | 1.41 ratio | Standard Deviation 1 |
Primary
MRCmax of OCA-glucuronide at Week 12
MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRCmax of OCA-glucuronide at Week 12 | 0.384 ratio | Standard Deviation 0.275 |
Primary
MRCmax of OCA-glucuronide at Week 18
MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRCmax of OCA-glucuronide at Week 18 | 0.236 ratio | Standard Deviation 0.0942 |
| OCA 5 mg Twice Weekly | MRCmax of OCA-glucuronide at Week 18 | 0.891 ratio | Standard Deviation 0.985 |
Primary
MRCmax of OCA-glucuronide at Week 24
MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRCmax of OCA-glucuronide at Week 24 | 0.165 ratio | Standard Deviation 0.0959 |
| OCA 5 mg Twice Weekly | MRCmax of OCA-glucuronide at Week 24 | 0.261 ratio | — |
| OCA 10 mg Twice Weekly | MRCmax of OCA-glucuronide at Week 24 | 0.727 ratio | Standard Deviation 0.701 |
Primary
MRCmax of OCA-glucuronide at Week 30
MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRCmax of OCA-glucuronide at Week 30 | 0.104 ratio | — |
| OCA 5 mg Twice Weekly | MRCmax of OCA-glucuronide at Week 30 | 0.257 ratio | Standard Deviation 0.217 |
| OCA 10 mg Twice Weekly | MRCmax of OCA-glucuronide at Week 30 | 1.11 ratio | Standard Deviation 1.11 |
Primary
MRCmax of OCA-glucuronide at Week 48
MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | MRCmax of OCA-glucuronide at Week 48 | 0.411 ratio | Standard Deviation 0.444 |
| OCA 10 mg Twice Weekly | MRCmax of OCA-glucuronide at Week 48 | 0.482 ratio | Standard Deviation 0.479 |
Primary
MRCmax of Tauro-OCA at Week 12
MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRCmax of Tauro-OCA at Week 12 | 2.24 ratio | Standard Deviation 2.46 |
Primary
MRCmax of Tauro-OCA at Week 18
MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRCmax of Tauro-OCA at Week 18 | 0.434 ratio | Standard Deviation 0.156 |
| OCA 5 mg Twice Weekly | MRCmax of Tauro-OCA at Week 18 | 3.32 ratio | Standard Deviation 4.12 |
Primary
MRCmax of Tauro-OCA at Week 24
MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRCmax of Tauro-OCA at Week 24 | 0.881 ratio | Standard Deviation 0.249 |
| OCA 5 mg Twice Weekly | MRCmax of Tauro-OCA at Week 24 | 0.332 ratio | — |
| OCA 10 mg Twice Weekly | MRCmax of Tauro-OCA at Week 24 | 2.63 ratio | Standard Deviation 2.13 |
Primary
MRCmax of Tauro-OCA at Week 30
MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | MRCmax of Tauro-OCA at Week 30 | 0.332 ratio | — |
| OCA 5 mg Twice Weekly | MRCmax of Tauro-OCA at Week 30 | 0.855 ratio | Standard Deviation 0.0746 |
| OCA 10 mg Twice Weekly | MRCmax of Tauro-OCA at Week 30 | 3.85 ratio | Standard Deviation 3.73 |
Primary
MRCmax of Tauro-OCA at Week 48
MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) \* ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Twice Weekly | MRCmax of Tauro-OCA at Week 48 | 0.468 ratio | Standard Deviation 0.206 |
| OCA 10 mg Twice Weekly | MRCmax of Tauro-OCA at Week 48 | 1.67 ratio | Standard Deviation 0.989 |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. An SAE was any AE that results in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in in-patient hospitalization or prolonged an existing hospitalization, was a congenital anomaly/birth defect, or was an important medical event that could jeopardize the participant or could have required medical intervention to prevent one of the outcomes listed above. TEAE was defined as any AE if it met one or more of the following criteria: 1) An AE started on or after the first study drug dose and within 30 days after the last dose of study drug, 2) An AE occurred prior to the first study drug dose that worsens (increase in grade) after the first study drug dose.
Time frame: Baseline up to approximately 3 years
Population: The Safety Population included all participants who received at least 1 dose of investigational product (OCA or placebo). Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any TEAE | 12 Participants |
| OCA 5 mg Once Weekly | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAE | 9 Participants |
| OCA 5 mg Twice Weekly | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Any TEAE | 10 Participants |
| OCA 5 mg Twice Weekly | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAE | 7 Participants |
Primary
Time to Maximum Concentration (Tmax) of Total OCA at Week 12
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Time to Maximum Concentration (Tmax) of Total OCA at Week 12 | 2.02 hours |
Primary
Tmax of Glyco-OCA at Week 12
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Glyco-OCA at Week 12 | 5.00 hours |
Primary
Tmax of Glyco-OCA at Week 18
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Glyco-OCA at Week 18 | 4.25 hours |
| OCA 5 mg Twice Weekly | Tmax of Glyco-OCA at Week 18 | 2.52 hours |
Primary
Tmax of Glyco-OCA at Week 24
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Glyco-OCA at Week 24 | 5.04 hours |
| OCA 5 mg Twice Weekly | Tmax of Glyco-OCA at Week 24 | 5.00 hours |
| OCA 10 mg Twice Weekly | Tmax of Glyco-OCA at Week 24 | 4.54 hours |
Primary
Tmax of Glyco-OCA at Week 30
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Glyco-OCA at Week 30 | 6.00 hours |
| OCA 5 mg Twice Weekly | Tmax of Glyco-OCA at Week 30 | 14.0 hours |
| OCA 10 mg Twice Weekly | Tmax of Glyco-OCA at Week 30 | 4.51 hours |
Primary
Tmax of Glyco-OCA at Week 48
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Twice Weekly | Tmax of Glyco-OCA at Week 48 | 5.00 hours |
| OCA 10 mg Twice Weekly | Tmax of Glyco-OCA at Week 48 | 4.03 hours |
Primary
Tmax of OCA-glucuronide at Week 12
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of OCA-glucuronide at Week 12 | 2.50 hours |
Primary
Tmax of OCA-glucuronide at Week 18
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of OCA-glucuronide at Week 18 | 1.25 hours |
| OCA 5 mg Twice Weekly | Tmax of OCA-glucuronide at Week 18 | 2.73 hours |
Primary
Tmax of OCA-glucuronide at Week 24
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of OCA-glucuronide at Week 24 | 2.54 hours |
| OCA 5 mg Twice Weekly | Tmax of OCA-glucuronide at Week 24 | 1.00 hours |
| OCA 10 mg Twice Weekly | Tmax of OCA-glucuronide at Week 24 | 2.27 hours |
Primary
Tmax of OCA-glucuronide at Week 30
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of OCA-glucuronide at Week 30 | 1.50 hours |
| OCA 5 mg Twice Weekly | Tmax of OCA-glucuronide at Week 30 | 2.26 hours |
| OCA 10 mg Twice Weekly | Tmax of OCA-glucuronide at Week 30 | 4.51 hours |
Primary
Tmax of OCA-glucuronide at Week 48
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Twice Weekly | Tmax of OCA-glucuronide at Week 48 | 1.73 hours |
| OCA 10 mg Twice Weekly | Tmax of OCA-glucuronide at Week 48 | 1.54 hours |
Primary
Tmax of Tauro-OCA at Week 12
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Tauro-OCA at Week 12 | 5.00 hours |
Primary
Tmax of Tauro-OCA at Week 18
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Tauro-OCA at Week 18 | 5.00 hours |
| OCA 5 mg Twice Weekly | Tmax of Tauro-OCA at Week 18 | 2.52 hours |
Primary
Tmax of Tauro-OCA at Week 24
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Tauro-OCA at Week 24 | 5.54 hours |
| OCA 5 mg Twice Weekly | Tmax of Tauro-OCA at Week 24 | 9.00 hours |
| OCA 10 mg Twice Weekly | Tmax of Tauro-OCA at Week 24 | 4.05 hours |
Primary
Tmax of Tauro-OCA at Week 30
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Tauro-OCA at Week 30 | 6.00 hours |
| OCA 5 mg Twice Weekly | Tmax of Tauro-OCA at Week 30 | 4.52 hours |
| OCA 10 mg Twice Weekly | Tmax of Tauro-OCA at Week 30 | 4.03 hours |
Primary
Tmax of Tauro-OCA at Week 48
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Twice Weekly | Tmax of Tauro-OCA at Week 48 | 6.50 hours |
| OCA 10 mg Twice Weekly | Tmax of Tauro-OCA at Week 48 | 2.57 hours |
Primary
Tmax of Total OCA at Week 18
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Total OCA at Week 18 | 0.750 hours |
| OCA 5 mg Twice Weekly | Tmax of Total OCA at Week 18 | 2.52 hours |
Primary
Tmax of Total OCA at Week 24
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Total OCA at Week 24 | 5.04 hours |
| OCA 5 mg Twice Weekly | Tmax of Total OCA at Week 24 | 0.750 hours |
| OCA 10 mg Twice Weekly | Tmax of Total OCA at Week 24 | 2.27 hours |
Primary
Tmax of Total OCA at Week 30
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Total OCA at Week 30 | 1.00 hours |
| OCA 5 mg Twice Weekly | Tmax of Total OCA at Week 30 | 4.52 hours |
| OCA 10 mg Twice Weekly | Tmax of Total OCA at Week 30 | 3.77 hours |
Primary
Tmax of Total OCA at Week 48
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Twice Weekly | Tmax of Total OCA at Week 48 | 1.73 hours |
| OCA 10 mg Twice Weekly | Tmax of Total OCA at Week 48 | 4.03 hours |
Primary
Tmax of Unconjugated OCA at Week 12
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Unconjugated OCA at Week 12 | 1.43 hours |
Primary
Tmax of Unconjugated OCA at Week 18
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Unconjugated OCA at Week 18 | 0.750 hours |
| OCA 5 mg Twice Weekly | Tmax of Unconjugated OCA at Week 18 | 1.24 hours |
Primary
Tmax of Unconjugated OCA at Week 24
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Unconjugated OCA at Week 24 | 1.13 hours |
| OCA 5 mg Twice Weekly | Tmax of Unconjugated OCA at Week 24 | 0.500 hours |
| OCA 10 mg Twice Weekly | Tmax of Unconjugated OCA at Week 24 | 1.63 hours |
Primary
Tmax of Unconjugated OCA at Week 30
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Once Weekly | Tmax of Unconjugated OCA at Week 30 | 0.750 hours |
| OCA 5 mg Twice Weekly | Tmax of Unconjugated OCA at Week 30 | 1.17 hours |
| OCA 10 mg Twice Weekly | Tmax of Unconjugated OCA at Week 30 | 1.75 hours |
Primary
Tmax of Unconjugated OCA at Week 48
Time frame: Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| OCA 5 mg Twice Weekly | Tmax of Unconjugated OCA at Week 48 | 1.10 hours |
| OCA 10 mg Twice Weekly | Tmax of Unconjugated OCA at Week 48 | 0.500 hours |
Primary
Trough Concentration (Ctrough) of Total OCA at Week 12
Ctrough was considered as the concentration at 24-hours post-dose at Week 12. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time frame: 24 hours post-dose at Week 12
Population: Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OCA 5 mg Once Weekly | Trough Concentration (Ctrough) of Total OCA at Week 12 | 77.6 ng/mL | Standard Deviation 49.7 |
Secondary
Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Time frame: Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 12 | -0.0275 ng/mL |
| OCA 5 mg Once Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Baseline | 0.708 ng/mL |
| OCA 5 mg Once Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 6 | 0.0990 ng/mL |
| OCA 5 mg Once Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 18 | -0.0470 ng/mL |
| OCA 5 mg Once Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 24 | -0.00100 ng/mL |
| OCA 5 mg Once Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 30 | 0.0890 ng/mL |
| OCA 5 mg Once Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 36 | 0.118 ng/mL |
| OCA 5 mg Once Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 48 | -0.170 ng/mL |
| OCA 5 mg Twice Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 36 | -0.476 ng/mL |
| OCA 5 mg Twice Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 24 | -0.141 ng/mL |
| OCA 5 mg Twice Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Extension Month 3 | 1.36 ng/mL |
| OCA 5 mg Twice Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Baseline | 0.814 ng/mL |
| OCA 5 mg Twice Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 30 | -0.386 ng/mL |
| OCA 5 mg Twice Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 6 | 0.0770 ng/mL |
| OCA 5 mg Twice Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 12 | -0.289 ng/mL |
| OCA 5 mg Twice Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 48 | -0.510 ng/mL |
| OCA 5 mg Twice Weekly | Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 18 | -0.267 ng/mL |
Secondary
Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Time frame: Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 11.5 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 47.5 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | -9.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -6.5 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -6.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -8.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | -5.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -12.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -4.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -5.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -34.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -6.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | -32.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 1.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 1.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | 1.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 38.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -2.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 2.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 10.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -0.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -4.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | 1.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -3.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | -1.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -1.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -1.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | -6.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -2.0 U/L |
Secondary
Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Time frame: Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -2.25 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | -1.25 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -4.25 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -0.50 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 34.50 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -2.50 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -2.50 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -2.00 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | -1.00 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -2.50 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -1.00 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -2.00 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | -1.00 g/L |
| OCA 5 mg Once Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -2.00 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 0.00 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | -11.70 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 33.00 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -0.50 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -0.70 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | 0.00 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -2.50 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | 0.15 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 0.50 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | -0.70 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 0.50 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 1.00 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -0.35 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | -1.35 g/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -2.70 g/L |
Secondary
Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Time frame: Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 216.0 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -21.0 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | -7.0 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -1.0 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -20.5 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -30.0 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -34.5 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -26.0 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | -24.0 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -29.0 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -24.0 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | 6.0 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -72.0 unit per liter (U/L) |
| OCA 5 mg Once Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | -83.0 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 122.0 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -4.0 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 267.5 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -46.0 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -9.0 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 5.0 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 5.0 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | -66.5 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -17.0 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 8.0 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -4.5 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | 10.0 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -5.0 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 10.0 unit per liter (U/L) |
| OCA 5 mg Twice Weekly | Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -20.0 unit per liter (U/L) |
Secondary
Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Time frame: Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 60.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -4.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | -4.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 0.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -1.5 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -7.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -10.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 19.5 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | -3.5 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -12.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -6.5 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -16.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -33.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | -34.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 19.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 2.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 65.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -0.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -1.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 1.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 10.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | -8.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 18.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 0.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -5.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | 16.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -2.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -12.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | 1.0 U/L |
Secondary
Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
The Child-Pugh classification was a scoring system used for the classification of the severity of cirrhosis. It included three continuous variables (bilirubin, albumin, and INR) and two discrete variables (ascites and encephalopathy). Each variable was scored 1-3 with 3 indicating most severe derangement. The determination of Child-Pugh score ranged from 5 to 15. The higher the score, the sicker the participant.
Time frame: Baseline, Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 8.0 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Day 1 | 0.0 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 0.0 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -0.5 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | 0.0 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -1.0 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -0.5 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -1.0 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -0.5 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 0.0 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | 1.0 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 1.0 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | 1.0 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -1.0 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 8.0 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 0.0 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Day 1 | 0.0 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -0.5 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 0.0 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | 0.0 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 0.0 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 0.0 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -0.5 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | 0.0 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | 0.0 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 0.0 score on a scale |
Secondary
Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Time frame: Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 60.000 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | 0.884 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 5.000 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -0.496 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -2.431 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -1.000 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -0.663 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 1.500 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 2.000 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 2.221 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 3.884 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | 2.652 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 10.608 µmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | 4.420 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 27.404 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 2.466 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 60.172 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | 4.648 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -0.308 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 6.236 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 0.884 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | 15.068 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 2.500 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 0.466 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | 0.942 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | 29.172 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -2.652 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 0.000 µmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -2.250 µmol/L |
Secondary
Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Time frame: Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 21.58 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | 0.00 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 2.53 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 4.28 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | 2.99 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | 1.00 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | 0.93 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 0.00 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 2.50 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 3.61 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 3.37 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | 0.00 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -9.41 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | -5.99 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 7.41 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -1.57 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 25.50 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -1.00 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -1.07 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | -1.71 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | -1.32 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | -3.79 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -1.14 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -2.36 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -1.82 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | 12.54 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -1.75 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -2.00 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -2.50 μmol/L |
Secondary
Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Time frame: Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 6 | -50.7 picograms per milliliter (pg/mL) |
| OCA 5 mg Once Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 30 | -83.0 picograms per milliliter (pg/mL) |
| OCA 5 mg Once Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 18 | -57.0 picograms per milliliter (pg/mL) |
| OCA 5 mg Once Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 36 | 26.0 picograms per milliliter (pg/mL) |
| OCA 5 mg Once Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 12 | -14.0 picograms per milliliter (pg/mL) |
| OCA 5 mg Once Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 48 | -28.5 picograms per milliliter (pg/mL) |
| OCA 5 mg Once Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 24 | -33.0 picograms per milliliter (pg/mL) |
| OCA 5 mg Once Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Extension Month 3 | -117 picograms per milliliter (pg/mL) |
| OCA 5 mg Once Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Baseline | 278 picograms per milliliter (pg/mL) |
| OCA 5 mg Twice Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Extension Month 3 | 0 picograms per milliliter (pg/mL) |
| OCA 5 mg Twice Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Baseline | 163 picograms per milliliter (pg/mL) |
| OCA 5 mg Twice Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 6 | 26.0 picograms per milliliter (pg/mL) |
| OCA 5 mg Twice Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 12 | 119 picograms per milliliter (pg/mL) |
| OCA 5 mg Twice Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 18 | 136 picograms per milliliter (pg/mL) |
| OCA 5 mg Twice Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 24 | 16.6 picograms per milliliter (pg/mL) |
| OCA 5 mg Twice Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 30 | 142 picograms per milliliter (pg/mL) |
| OCA 5 mg Twice Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 36 | 15.0 picograms per milliliter (pg/mL) |
| OCA 5 mg Twice Weekly | Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 48 | 69.6 picograms per milliliter (pg/mL) |
Secondary
Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Time frame: Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 98.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -12.5 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | -11.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -13.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -9.5 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | 8.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -9.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -5.5 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | -12.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -9.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -9.5 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -10.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -74.0 U/L |
| OCA 5 mg Once Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | -63.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 8.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -10.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 103.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -58.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -13.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | -4.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 0.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | -57.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -2.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -15.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -3.5 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | 2.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -14.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 9.0 U/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -12.5 U/L |
Secondary
Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
The MELD-Na scoring system is used to assess the severity of chronic liver disease in the participants with an initial MELD(i) score greater than 11. MELD-Na score is derived from the participant's serum total bilirubin, serum creatinine, INR, and sodium. The MELD-Na score is re-calculated as follows: MELD-Na = MELD(i) + 1.32\*(137-Na) - \[0.033\*MELD(i)\*(137-Na)\]. MELD score ranges from 6-40 with higher scores indicating more severe liver disease and a worse outcome. The MELD(i) score is derived from the participant's serum total bilirubin, serum creatinine, and prothrombin international normalized ratio (INR): 3.78×log normal (ln) \[total bilirubin (mg/deciliter \[dL\])\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43. The MELD score ranges from 6 to 40 with higher scores indicating more severe liver disease and a worse outcome.
Time frame: Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | -1.00 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | 0.00 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 0.50 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 0.50 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | 0.65 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | 0.15 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | 0.15 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 0.15 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 0.00 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 0.65 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 2.50 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | 0.00 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -1.00 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 11.75 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -1.00 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 13.25 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -0.25 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | 0.50 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 4.50 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | -0.25 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 0.50 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 0.50 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | 1.75 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -0.75 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -1.75 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -2.00 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | 0.75 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -0.75 score on a scale |
Secondary
Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Time frame: Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 141.5 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -6.2 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | -12.0 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -10.5 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -15.0 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | 4.5 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -11.4 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -16.5 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | -16.2 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 4.0 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -5.0 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | 48.5 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -2.0 10^9/L |
| OCA 5 mg Once Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | -9.0 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -3.5 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 9.8 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 132.5 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -0.5 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -7.5 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 9.0 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 15.0 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | -4.5 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -15.0 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -9.0 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | 7.5 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | -22.5 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -1.5 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -11.5 10^9/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -5.5 10^9/L |
Secondary
Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Time frame: Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | 0.05 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | 0.00 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 0.00 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 0.08 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | 0.09 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | 0.03 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | 0.03 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 0.05 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 0.05 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 0.00 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 0.06 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | 0.05 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | 0.15 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 0.05 INR |
| OCA 5 mg Once Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 1.15 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 1.23 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -0.10 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | 0.00 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | 0.00 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 0.00 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 0.00 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -0.05 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -0.05 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -0.05 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -0.10 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -0.05 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 0.10 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | 0.00 INR |
| OCA 5 mg Twice Weekly | Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -0.10 INR |
Secondary
Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
The MELD scoring system is used to assess the severity of chronic liver disease. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and prothrombin international normalized ratio (INR): 3.78×log normal (ln) \[total bilirubin (mg/deciliter \[dL\])\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43. The MELD score ranges from 6 to 40 with higher scores indicating more severe liver disease and a worse outcome.
Time frame: Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | -1.00 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | 0.50 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 0.50 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 0.75 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | 0.65 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | 0.15 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | 0.15 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 0.15 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 0.65 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 0.65 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 0.50 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | 0.00 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -1.00 score on a scale |
| OCA 5 mg Once Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 11.75 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | -1.00 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 12.75 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 0.25 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | 0.00 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 4.50 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 0.00 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 0.50 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 0.00 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | 0.25 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -0.75 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -1.75 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -1.50 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | 0.75 score on a scale |
| OCA 5 mg Twice Weekly | Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -1.25 score on a scale |
Secondary
Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Total bile acids (micromole \[μM\]) = total ursodeoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total chenodeoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total deoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total cholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total lithocholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM.
Time frame: Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Baseline | 149 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 6 | 16.3 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 12 | 0.863 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 18 | 17.7 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 24 | 3.29 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 30 | 26.0 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 36 | -15.2 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 48 | 63.2 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 36 | -1.54 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 24 | -3.14 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Baseline | 127 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Extension Month 3 | -32.9 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 6 | 8.09 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 30 | 16.1 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 12 | 5.55 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 48 | 0.876 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 18 | 12.8 μM |
Secondary
Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Time frame: Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 45.38 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | 0.86 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | 3.00 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | 0.86 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | 1.08 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | 2.67 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | 2.08 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | 4.25 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 6.58 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | 6.25 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 2.25 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -1.50 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | -14.54 μmol/L |
| OCA 5 mg Once Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | -12.83 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 12 | 9.12 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 36 | -3.53 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Baseline | 41.50 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 6 | -0.22 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 3 | -3.25 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 42 | 1.71 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 6 | -2.14 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 9 | -7.86 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 12 | -1.71 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 48 | -3.75 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 18 | -4.03 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 15 | 24.51 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 24 | -3.50 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Extension Month 3 | 0.50 μmol/L |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15 | Change at Week 30 | -8.49 μmol/L |
Secondary
Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Total endogenous bile acids (μM) = total chenodeoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total deoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total cholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total lithocholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM.
Time frame: Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| OCA 5 mg Once Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 30 | 6.74 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 18 | -5.00 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 36 | -5.74 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 12 | -3.97 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 48 | 10.9 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 24 | -6.76 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 6 | -4.98 μM |
| OCA 5 mg Once Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Baseline | 64.7 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Extension Month 3 | -9.57 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 24 | 3.18 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 6 | 3.58 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 12 | 1.46 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 18 | 3.98 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Baseline | 42.1 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 30 | 1.47 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 36 | -2.69 μM |
| OCA 5 mg Twice Weekly | Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3 | Change at Week 48 | 4.18 μM |
Secondary
Number of Participants by Child-Pugh Score Component Category (Ascites Categories)
Number of participants with Child-Pugh component - ascites categories of none, mild, and moderate-severe has been reported. The ascites categories were defined per investigator's discretion.
Time frame: Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 12 | Mild | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Baseline | Mild | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Baseline | Moderate-Severe | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Day 1 | None | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Day 1 | Mild | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Day 1 | Moderate-Severe | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 6 | None | 7 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 6 | Mild | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 6 | Moderate-Severe | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 12 | None | 4 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Baseline | None | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 12 | Moderate-Severe | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 18 | None | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 18 | Mild | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 18 | Moderate-Severe | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 24 | None | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 24 | Mild | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 24 | Moderate-Severe | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 30 | None | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 30 | Mild | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 30 | Moderate-Severe | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 36 | None | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 36 | Mild | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 36 | Moderate-Severe | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 48 | None | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 48 | Mild | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 48 | Moderate-Severe | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 3 | None | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 3 | Mild | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 3 | Moderate-Severe | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 6 | None | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 6 | Mild | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 6 | Moderate-Severe | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 9 | None | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 9 | Mild | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 9 | Moderate-Severe | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 12 | None | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 12 | Mild | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 12 | Moderate-Severe | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 15 | None | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 15 | Mild | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 15 | Moderate-Severe | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 6 | Mild | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Baseline | None | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 36 | None | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Baseline | Mild | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 15 | None | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Baseline | Moderate-Severe | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 36 | Mild | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Day 1 | None | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 6 | Moderate-Severe | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Day 1 | Mild | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 36 | Moderate-Severe | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Day 1 | Moderate-Severe | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 12 | Mild | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 6 | None | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 48 | None | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 6 | Mild | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 9 | None | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 6 | Moderate-Severe | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 48 | Mild | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 12 | None | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 15 | Moderate-Severe | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 12 | Mild | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 48 | Moderate-Severe | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 12 | Moderate-Severe | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 9 | Mild | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 18 | None | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 3 | None | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 18 | Mild | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 12 | Moderate-Severe | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 18 | Moderate-Severe | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 3 | Mild | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 24 | None | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 9 | Moderate-Severe | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 24 | Mild | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 3 | Moderate-Severe | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 24 | Moderate-Severe | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 15 | Mild | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 30 | None | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 6 | None | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 30 | Mild | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Extension Month 12 | None | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Ascites Categories) | Week 30 | Moderate-Severe | 0 Participants |
Secondary
Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories)
Number of participants with Child-Pugh component - Hepatic encephalopathy in categories of Grade 0, Grade 1 or 2, and Grade 3 and 4 has been reported. Grade 0: normal consciousness, normal personality, normal neurological examination, normal electroencephalogram. Grade 1: restless, sleep disturbed, irritable/agitated, tremor, impaired handwriting, 5 cycles, per second (cps) waves. Grade 2: lethargic, time-disoriented, inappropriate, asterixis, ataxia, slow triphasic waves. Grade 3: somnolent, stuporous, place-disoriented, hyperactive reflexes, rigidity, slower waves. Grade 4: unrousable coma, no personality/behavior, decerebrate, slow 2-3 cps delta activity.
Time frame: Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 12 | Grade 1 or 2 | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Baseline | Grade 1 or 2 | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Baseline | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Day 1 | Grade 0 | 8 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Day 1 | Grade 1 or 2 | 4 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Day 1 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 6 | Grade 0 | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 6 | Grade 1 or 2 | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 6 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 12 | Grade 0 | 4 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Baseline | Grade 0 | 7 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 12 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 18 | Grade 0 | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 18 | Grade 1 or 2 | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 18 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 24 | Grade 0 | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 24 | Grade 1 or 2 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 24 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 30 | Grade 0 | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 30 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 30 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 36 | Grade 0 | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 36 | Grade 1 or 2 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 36 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 48 | Grade 0 | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 48 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 48 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 3 | Grade 0 | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 3 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 3 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 6 | Grade 0 | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 6 | Grade 1 or 2 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 6 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 9 | Grade 0 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 9 | Grade 1 or 2 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 9 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 12 | Grade 0 | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 12 | Grade 1 or 2 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 12 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 15 | Grade 0 | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 15 | Grade 1 or 2 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 15 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 6 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Baseline | Grade 0 | 7 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 36 | Grade 0 | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Baseline | Grade 1 or 2 | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 15 | Grade 0 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Baseline | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 36 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Day 1 | Grade 0 | 8 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 6 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Day 1 | Grade 1 or 2 | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 36 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Day 1 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 12 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 6 | Grade 0 | 6 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 48 | Grade 0 | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 6 | Grade 1 or 2 | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 9 | Grade 0 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 6 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 48 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 12 | Grade 0 | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 15 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 12 | Grade 1 or 2 | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 48 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 12 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 9 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 18 | Grade 0 | 7 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 3 | Grade 0 | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 18 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 12 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 18 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 3 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 24 | Grade 0 | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 9 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 24 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 3 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 24 | Grade 3 or 4 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 15 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 30 | Grade 0 | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 6 | Grade 0 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 30 | Grade 1 or 2 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Extension Month 12 | Grade 0 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories) | Week 30 | Grade 3 or 4 | 0 Participants |
Secondary
Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories)
Number of participants with Child-Pugh component - prothrombin time (measured as INR) in categories of \<1.7, 1.7 - 2.3, and \>2.3 has been reported.
Time frame: Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 12 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Baseline | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Baseline | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Day 1 | <1.7 | 12 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Day 1 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Day 1 | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 6 | <1.7 | 9 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 6 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 6 | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 12 | <1.7 | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Baseline | <1.7 | 12 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 12 | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 18 | <1.7 | 8 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 18 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 18 | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 24 | <1.7 | 4 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 24 | 1.7 - 2.3 | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 24 | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 30 | <1.7 | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 30 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 30 | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 36 | <1.7 | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 36 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 36 | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 48 | <1.7 | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 48 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 48 | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 3 | <1.7 | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 3 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 3 | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 6 | <1.7 | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 6 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 6 | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 9 | <1.7 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 9 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 9 | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 12 | <1.7 | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 12 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 12 | >2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 15 | <1.7 | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 15 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 15 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 6 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Baseline | <1.7 | 10 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 36 | <1.7 | 6 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Baseline | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 15 | <1.7 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Baseline | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 36 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Day 1 | <1.7 | 10 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 6 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Day 1 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 36 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Day 1 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 12 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 6 | <1.7 | 9 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 48 | <1.7 | 6 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 6 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 9 | <1.7 | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 6 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 48 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 12 | <1.7 | 7 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 15 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 12 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 48 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 12 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 9 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 18 | <1.7 | 8 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 3 | <1.7 | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 18 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 12 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 18 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 3 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 24 | <1.7 | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 9 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 24 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 3 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 24 | >2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 15 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 30 | <1.7 | 6 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 6 | <1.7 | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 30 | 1.7 - 2.3 | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Extension Month 12 | <1.7 | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories) | Week 30 | >2.3 | 0 Participants |
Secondary
Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories)
Number of participants with Child-Pugh component - serum albumin levels in categories of \>35 gram per liter (g/L), 28-35 g/L, or \<28 g/L has been reported.
Time frame: Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 6 | >35 g/L | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 30 | <28 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Day 1 | 28 - 35 g/L | 9 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 36 | >35 g/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 6 | 28 - 35 g/L | 7 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 36 | 28 - 35 g/L | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Baseline | >35 g/L | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 36 | <28 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 6 | <28 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 48 | >35 g/L | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Day 1 | <28 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 48 | 28 - 35 g/L | 4 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 18 | >35 g/L | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 48 | <28 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Baseline | <28 g/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 3 | >35 g/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 18 | 28 - 35 g/L | 6 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 3 | 28 - 35 g/L | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 12 | >35 g/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 3 | <28 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 18 | <28 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 6 | >35 g/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 9 | >35 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 6 | 28 - 35 g/L | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 24 | >35 g/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 12 | 28 - 35 g/L | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 9 | 28 - 35 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 24 | 28 - 35 g/L | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 9 | <28 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Day 1 | >35 g/L | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 12 | >35 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 24 | <28 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 12 | 28 - 35 g/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 12 | <28 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 12 | <28 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 30 | >35 g/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 15 | >35 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Baseline | 28 - 35 g/L | 8 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 15 | 28 - 35 g/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 30 | 28 - 35 g/L | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 15 | <28 g/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 6 | <28 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 15 | <28 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 6 | <28 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Baseline | >35 g/L | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Baseline | 28 - 35 g/L | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Baseline | <28 g/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Day 1 | >35 g/L | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Day 1 | 28 - 35 g/L | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Day 1 | <28 g/L | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 12 | >35 g/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 12 | 28 - 35 g/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 12 | <28 g/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 6 | >35 g/L | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 6 | 28 - 35 g/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 6 | <28 g/L | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 18 | >35 g/L | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 18 | 28 - 35 g/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 18 | <28 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 24 | >35 g/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 24 | 28 - 35 g/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 24 | <28 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 30 | >35 g/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 30 | 28 - 35 g/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 30 | <28 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 36 | >35 g/L | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 36 | 28 - 35 g/L | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 36 | <28 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 48 | >35 g/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 48 | 28 - 35 g/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Week 48 | <28 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 3 | >35 g/L | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 3 | 28 - 35 g/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 3 | <28 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 6 | >35 g/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 6 | 28 - 35 g/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 9 | >35 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 9 | 28 - 35 g/L | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 9 | <28 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 12 | >35 g/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 12 | 28 - 35 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 12 | <28 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 15 | >35 g/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories) | Extension Month 15 | 28 - 35 g/L | 1 Participants |
Secondary
Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories)
Number of participants with Child-Pugh component - total bilirubin levels in categories of \<34 micromole per liter (µmol/L), 34-50 µmol/L, and \>50 µmol/L has been reported.
Time frame: Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15
Population: Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 30 | >50 µmol/L | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 24 | >50 µmol/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 36 | <34 µmol/L | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 6 | >50 µmol/L | 4 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 36 | 34-50 µmol/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Baseline | >50 µmol/L | 4 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 36 | >50 µmol/L | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 12 | <34 µmol/L | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 48 | <34 µmol/L | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 3 | <34 µmol/L | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 48 | 34-50 µmol/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 12 | 34-50 µmol/L | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 48 | >50 µmol/L | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Day 1 | 34-50 µmol/L | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 3 | 34-50 µmol/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 12 | >50 µmol/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 3 | >50 µmol/L | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Baseline | <34 µmol/L | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 6 | <34 µmol/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 18 | <34 µmol/L | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 6 | 34-50 µmol/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Day 1 | >50 µmol/L | 4 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 6 | >50 µmol/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 18 | >50 µmol/L | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 9 | <34 µmol/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 18 | 34-50 µmol/L | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 9 | 34-50 µmol/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 24 | <34 µmol/L | 2 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 9 | >50 µmol/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 6 | <34 µmol/L | 4 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 12 | <34 µmol/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 24 | 34-50 µmol/L | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 12 | 34-50 µmol/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 30 | <34 µmol/L | 3 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 12 | >50 µmol/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Baseline | 34-50 µmol/L | 5 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 15 | <34 µmol/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 30 | 34-50 µmol/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 15 | 34-50 µmol/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 6 | 34-50 µmol/L | 1 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 15 | >50 µmol/L | 0 Participants |
| OCA 5 mg Once Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Day 1 | <34 µmol/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 15 | >50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Day 1 | <34 µmol/L | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 18 | <34 µmol/L | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 24 | 34-50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 24 | >50 µmol/L | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 48 | >50 µmol/L | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Baseline | <34 µmol/L | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Baseline | 34-50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Baseline | >50 µmol/L | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Day 1 | 34-50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Day 1 | >50 µmol/L | 5 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 6 | <34 µmol/L | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 6 | 34-50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 6 | >50 µmol/L | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 12 | <34 µmol/L | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 12 | 34-50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 12 | >50 µmol/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 18 | 34-50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 18 | >50 µmol/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 24 | <34 µmol/L | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 30 | <34 µmol/L | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 30 | 34-50 µmol/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 30 | >50 µmol/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 36 | <34 µmol/L | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 36 | 34-50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 36 | >50 µmol/L | 2 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 48 | <34 µmol/L | 4 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Week 48 | 34-50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 3 | <34 µmol/L | 3 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 3 | 34-50 µmol/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 3 | >50 µmol/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 6 | <34 µmol/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 6 | 34-50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 6 | >50 µmol/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 9 | <34 µmol/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 9 | 34-50 µmol/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 9 | >50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 12 | <34 µmol/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 12 | 34-50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 12 | >50 µmol/L | 0 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 15 | <34 µmol/L | 1 Participants |
| OCA 5 mg Twice Weekly | Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories) | Extension Month 15 | 34-50 µmol/L | 0 Participants |