Actively Recruiting
Long-Term Study of Fenofibrate for Treating Primary Biliary Cholangitis Evaluating Safety and Effectiveness in Adults Aged 18 to 75
Led by Xijing Hospital of Digestive Diseases · Updated on 2025-07-02
117
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term safety and effectiveness of fenofibrate in adults with Primary Biliary Cholangitis PBC. The trial is open-label and includes participants who have previously taken part in a related fenofibrate study for PBC. The study is sponsored by Xijing Hospital of Digestive Diseases and involves patients aged 18 to 75 years. Participants are randomly assigned to receive either ursodeoxycholic acid UDCA alone or UDCA combined with fenofibrate 200 mgday. UDCA is given at a dose of 13-15 mgkgday. The study monitors patients over a long period, up to 120 months, to observe treatment effects and safety. Throughout the study, researchers track treatment emergent adverse events and biochemical responses to the treatments. Participants provide written consent and must follow contraceptive measures if of reproductive potential. The study involves regular monitoring to assess safety and treatment response, with full participation expected over the study duration ending in April 2027.
CONDITIONS
Brief Title
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Research Team
Y
Yansheng Liu, MD
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