Primary Biliary Cholangitis
Conditions
Keywords
Primary Biliary Cholangitis, Primary Biliary Cirrhosis, PBC, Hepatic Impairment, Cirrhosis, Liver
Brief summary
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
Interventions
DRUGObeticholic acid
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily
200 mg IR tablet of Bezafibrate once daily for the remainder of the study
DRUGOCA Placebo
One tablet daily for the remainder of the study
DRUGBezafibrate 200 mg Placebo
One tablet daily for the remainder of the study
DRUGBezafibrate 400 MG
400 mg SR tablet of Bezafibrate once daily for the remainder of the study
DRUGBezafibrate 400 mg Placebo
One tablet daily for the remainder of the study
DRUGOCA
OCA one tablet will be administered.
DRUGBezafibrate
Bezafibrate one tablet will be administered.
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 No maximum
Healthy volunteers
No
Inclusion criteria
* A definite or probable diagnosis of PBC * Qualifying ALP and/or bilirubin liver biochemistry values * Taking Ursodeoxycholic Acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1
Exclusion criteria
* History or presence of other concomitant liver diseases * Clinical complications of PBC * History or presence of hepatic decompensating events * Current or history of gallbladder disease * If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating * Treatment with commercially available OCA or other farnesoid X receptor (FXR) agonists, or participation in a previous study involving OCA within 3 months before Screening. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Alkaline Phosphatase (ALP) from baseline to Week 12 in the DB Treatment Period | Baseline, Day 1, and Weeks 4, 8, and 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change in lipid panel from baseline to Week 12 | Baseline, Day 1, and Weeks 4, 8, and 12 |
| Change in 7 alpha (α) hydroxy 4 cholesten-3 one (C4) from baseline to Week 12 | Baseline, Day 1, and Weeks 4, 8, and 12 |
| Response rates of ≥10%, ≥20%, ≥30% and ≥40% reduction, and normalization of biochemical disease marker Alkaline Phosphatase (ALP) | Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12 |
| Number of participants with normalization rates of biochemical disease marker Alanine Aminotransferase (ALT), Gamma-Glutamyl Transpeptidase (GGT), Aspartate Aminotransferase (AST), total and conjugated bilirubin and lipid panel | Baseline, Day 1, and Weeks 2, 4, 6, 8, and 12 |
| Change in total and conjugated bilirubin from baseline to Week 12 | Baseline, Day 1, and Weeks 4, 8, and 12 |
| Change in ALT from baseline to Week 12 | Baseline, Day 1, and Weeks 4, 8, and 12 |
| Change in AST from baseline to Week 12 | Baseline, Day 1, and Weeks 4, 8, and 12 |
| Change in bile acid from baseline to Week 12 | Baseline, Day 1, and Weeks 4,8, and 12 |
| Change in GGT from baseline to Week 12 | Baseline, Day 1, and Weeks 4, 8, and 12 |
Countries
Australia, Belgium, Croatia, Czechia, Estonia, France, Germany, Greece, Hungary, Israel, Lithuania, Netherlands, Norway, Poland, South Korea, Spain, United Kingdom
Outcome results
None listed