Long-Term Study of Fenofibrate with Ursodeoxycholic Acid for Primary Biliary Cholangitis Safety and Tolerability

What this Trial Is About

This trial evaluates the safety and tolerability of fenofibrate combined with ursodeoxycholic acid in adults with Primary Biliary Cholangitis PBC. It is a long-term, open-label Phase 3 study sponsored by Xijing Hospital of Digestive Diseases, focusing on patients continuing after a previous PBC fenofibrate study. The goal is to observe treatment effects and adverse events over an extended period. Participants receive fenofibrate as 200 mg capsules alongside ursodeoxycholic acid. The study does not include a placebo group and involves ongoing treatment with this combination. The trial spans up to 120 months, allowing researchers to track long-term safety and liver-related outcomes. Throughout the study, participants will be monitored for treatment-emergent adverse events, death, liver transplantation, and normalization of alkaline phosphatase ALP levels. Researchers will collect data continuously until study completion, with regular assessments to evaluate the safety and effectiveness of the treatment combination over time.

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study