Clinical Trial

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

Study acronym: AFFIRM
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Protocol Amendment History 5 changes
notable Trial sites expanded: 205 -> 211 locations 2026-08-12
notable Trial sites expanded: 199 -> 203 locations 2026-06-24
notable Trial sites expanded: 196 -> 199 locations 2026-05-27
notable Trial sites expanded: 191 -> 196 locations 2026-05-01
notable Trial sites expanded: 178 -> 191 locations 2026-04-02
Trial Details
NCT Number NCT06051617
Lead Sponsor Gilead Sciences
Conditions Primary Biliary Cholangitis
Enrollment 318 participants
Start Date 2023-09-07
Primary Completion 2030-08 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-11