NCT06051617

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 318 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Detailed description

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	Seladelpar	* Seladelpar 10 mg one capsule daily for up to 36 months in participants with CP-A cirrhosis or * Seladelpar 5 mg one capsule daily for up to 36 months in participants with CP-B cirrhosis.
DRUG	Placebo	One capsule daily for up to 36 months.

Timeline

• Start date: 2023-09-07
• Primary completion: 2030-08-01
• Completion: 2030-08-01
• First posted: 2023-09-25
• Last updated: 2026-04-01

Locations

191 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Mexico, Poland, Romania, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study