Long-Term Study of Fenofibrate Combined With Ursodeoxycholic Acid to Treat Primary Biliary Cholangitis PBC

What this Trial Is About

Researchers are studying the safety and tolerability of fenofibrate combined with ursodeoxycholic acid in people with Primary Biliary Cholangitis PBC, a liver condition. This long-term, open-label study is designed to assess how well participants tolerate this combination treatment and monitor any side effects over time. Participants will receive fenofibrate at a dose of 200 mg along with ursodeoxycholic acid. The study does not use a placebo or blinding, and all participants know the treatment they are receiving. It is a phase 3 trial conducted over a period of up to 120 months 10 years, allowing researchers to observe long-term effects and outcomes. During the study, participants will be closely monitored for treatment-related side effects and adverse events. Researchers will track serious outcomes such as death, liver transplantation, and the normalization of alkaline phosphatase ALP levels. Participants will undergo regular assessments throughout the trial to ensure safety and gather detailed information on the treatments impact over time.

Fenofibrate in Primary Biliary Cholangitis: a Real World Study