Study of Seladelpar to Treat Primary Biliary Cholangitis with Compensated Cirrhosis A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial

What this Trial Is About

This research aims to evaluate the effects of Seladelpar on clinical outcomes in adults with Primary Biliary Cholangitis PBC who also have compensated cirrhosis. The study is a Phase 3 randomized, double-blind, placebo-controlled trial focusing on treatment outcomes for this liver condition. It is sponsored by Gilead Sciences and seeks to understand how Seladelpar may impact disease progression and survival in this specific patient group. Participants will be randomly assigned to receive either Seladelpar or a placebo daily for up to 36 months. Those with CP-A cirrhosis will take 10 mg capsules of Seladelpar, while those with CP-B cirrhosis will take 5 mg capsules. The placebo group will take one capsule daily as well. This long-term treatment period allows researchers to compare outcomes between the two groups effectively. During the study, participants will follow a schedule of assessments to monitor their health and response to the study drug. Researchers will measure outcomes such as event-free survival, overall survival, liver transplant-free survival, and time to hospitalization over 36 months. Safety and laboratory parameters will be regularly evaluated to ensure participant well-being throughout the trial.

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis