Primary Biliary Cholangitis
Conditions
Brief summary
The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC)
Interventions
Sponsors
Han Ying
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Must have provided written informed consent * Age 18-75 years; * BMI 17-28 kg/m2 * Male or female with a diagnosis of PBC, by at least two of the following criteria: 1. History of alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months; 2. Positive Anti-mitochondrial antibody (AMA) titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies; 3. Documented liver biopsy result consistent with PBC. * Incomplete response to UDCA defined by 1 x ULN\< ALP \<= 1.67 x ULN * Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0
Exclusion criteria
* History or presence of other concomitant liver diseases. * ALT or AST \> 5×ULN, total bilirubin（TBIL） \> 3×ULN. * If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating. * Allergic to fenofibrate or ursodeoxycholic acid. * Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users. Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites. * Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse). * Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min. * Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen). * Planned to receive an organ transplant or an organ transplant recipient. * Needing Liver transplantation within 1 year according to the Mayo Rick score. * Any other condition(s) that would compromise the safety of the subject or compromise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with biochemical response | 48 weeks | The normalisation of Alkaline Phosphatase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients having biochemical response | 4, 12, 24 and 36weeks | The normalisation of Alkaline Phosphatase at 4, 12, 24, and 36 weeks |
| Assessment of the pruritus | 4, 12, 24, 36, and 48 weeks | Change From Baseline in Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scores mean a worse outcome) |
| Assessment of the fatigue | 4, 12, 24, 36, and 48 weeks | Change From Baseline in Fatigue as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scores mean a worse outcome) |
| Percentage of patients having biological or clinical adverse events | 4, 12, 24, 36, and 48 weeks | Increase of creatinine, blood urea nitrogen, alanine aminotransferase and aspartate aminotransferase |
| Survival without transplantation and hepatic impairment | 48 weeks | Occurrence of ascites, variceal bleeding, hepatic encephalopathy, liver-transplantation, or death |
Countries
China
Outcome results
None listed