Study of Fenofibrate Plus Ursodeoxycholic Acid for Primary Biliary Cholangitis Patients Not Fully Responding to Ursodeoxycholic Acid

What this Trial Is About

Researchers are investigating the use of fenofibrate combined with ursodeoxycholic acid UDCA in patients with primary biliary cholangitis PBC who do not respond adequately to UDCA alone. This study addresses the challenge that about 40% of PBC patients are insensitive to UDCA monotherapy, and current guidelines recommend UDCA as the first-line treatment. A new early criterion called the Xian criterion helps identify patients unlikely to respond well after just one month of UDCA treatment, aiming to improve management and treatment options. This is a multi-center, randomized, placebo-controlled, double-blind trial where participants will receive either fenofibrate 200 mg daily or a placebo, in combination with UDCA at 13-15 mgkg daily, for 48 months. The study evaluates the efficacy and safety of fenofibrate added to UDCA in patients with incomplete biochemical response to UDCA based on the Xian criteria. Participants will be monitored regularly through biochemical tests, liver function markers, assessments of liver fibrosis, portal hypertension features, pruritus, and quality of life using validated scales. The primary outcome is the percentage of patients achieving complete normalization of alkaline phosphatase ALP and total bilirubin TBIL at 48 weeks. Secondary outcomes include adverse events, survival without liver transplantation or decompensation, and changes in liver function and quality of life over time.

Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis