drugset / Trial / NCT05749822

Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

NCT05749822

Phase 2/3 Recruiting 104 enrolled Xijing Hospital of Digestive Diseases
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2023-02-17
Primary completion
2027-12-01
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenofibrate Small molecule 200 mg
Background Ursodeoxycholic Acid Small molecule 13 mg/kg
Background Ursodeoxycholic Acid Small molecule 15 mg/kg