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

Date Added
January 15th, 2026
PRO Number
Pro00149131
Researcher
David Koch

List of Studies


Keywords
Hepatology, Liver
Summary

The purpose of this research study is to determine if Seladelpar is effective in reducing the number of health problems in people with primary biliary cholangitis (PBC) and to test if it is safe in people with PBC. Seladelpar has been approved by the United States Food and Drug Administration (U.S. FDA) to treat PBC. This is a randomized, double-blind, and placebo-controlled study. There will be about 318 participants in the study and the study will take place at about 250 locations globally. Participation in this study will be about 3 years and 2 months.

Institution
MUSC
Recruitment Contact
Rohini Rao
8437926109
recuitment@musc.edu



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