Phase 3Recruiting
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis (AFFIRM)
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
- Sponsor
- Gilead Sciences (Industry)
- Enrolment
- 402 planned
- Conditions
- Primary Biliary Cholangitis
- Interventions
- Seladelpar; Placebo
- Ages
- adults, older adults
- Registry
- NCT06051617
From the registry
The goal of this clinical study is to learn more about the study drug, seladelpar, and its effects on clinical outcomes in participants with primary biliary cholangitis (PBC) and compensated cirrhosis. The primary objective of this study is to evaluate the effect of seladelpar compared to placebo on EFS. EFS is defined as the time from start of treatment to the first occurrence of any of the following adjudicated events up to Week 156.
Primary outcomes
- Event Free Survival (EFS)