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

Research summary

This is a multicenter evaluation of seladelpar, administered as a once-daily oral capsule, in a randomized, double-blind, placebo-controlled, parallel-group study in subjects with PBC. This fixed-duration study (156 weeks) will randomize approximately 192 subjects across approximately 150 sites worldwide. The population to be studied is patients with PBC and compensated cirrhosis restricted to Child-Pugh (CP)-A or CP-B.

Principal Investigator

Dr Emma Culver

Contact us

Email: ouh-tr.ctfresearch@nhs.net

IRAS number

1010591