AFFIRM: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Brief description of study

The purpose of this study is to evaluate the effectiveness of seladelpar on mitigating liver-related symptoms and clinical events, when compared to the placebo, in patients with Primary Biliary Cholangitis (PBC) and compressed cirrhosis (CP-A or CP-B). The study will be "double-blind," meaning neither the patients nor the doctors will know who is getting what until after the study is done. The total duration of this study for patients enrolled is about 156 weeks (~3 years).

Clinical Study Identifier: s23-00581
Principal Investigator: Ira M. Jacobson.
Other Investigator: Monique Julia Carasso.

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