Study of Fenofibrate Combined With Ursodeoxycholic Acid for Adults Aged 18 to 75 With Compensated Cirrhosis and Primary Biliary Cholangitis Not Fully Responding to Ursodeoxycholic Acid

What this Trial Is About

Researchers are evaluating the effects and safety of fenofibrate in patients with compensated cirrhosis due to primary biliary cholangitis PBC who have not responded adequately to ursodeoxycholic acid UDCA. This multi-center, randomized, placebo-controlled study aims to assess whether adding fenofibrate to UDCA improves biochemical markers over 12 months. The study is conducted by Xijing Hospital of Digestive Diseases and includes participants aged 18 to 75 years with confirmed PBC and compensated cirrhosis. Participants will be randomly assigned to receive either fenofibrate 200 mg daily or a placebo, both combined with UDCA at 13-15 mgkg per day for 12 months. This quadruple-masked trial compares these two groups in parallel to evaluate fenofibrates biochemical response and safety profile. The treatment period lasts for one year with daily medication intake. Throughout the study, participants will have regular assessments including blood tests to measure biochemical response at multiple time points up to 48 weeks. Researchers will also monitor symptoms like itching and fatigue, track any biological or clinical adverse events, and evaluate survival without liver transplantation or hepatic impairment. Safety and treatment effects will be closely observed across the full duration of the trial.

Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis