AFFIRM Study for Primary Biliary Cholangitis and Compensated Cirrhosis
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
- Sex: Any
- Age: Adult (18 - 64), Older Adult (65+)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase IV
- Conditions Being Studied: Liver, Primary Biliary Cholangitis
Study Purpose
The purpose of this research study is to determine if seladelpar (study drug) is effective at improving clinical outcomes in subjects with PBC and compensated cirrhosis compared to placebo. This will be done by looking at changes in overall health, severity of symptoms, and progression of PBC.Seladelpar has demonstrated rapid and sustained decrease in biochemical markers of cholestasis, and improves PBC-related pruritus.
Who Can Participate
Age: 18-75
Locations
UH Cleveland Medical Center
11100 Euclid Ave
Cleveland OH, 44106
- UH IRB: STUDY20230582
- StudyID: 2023-01187
- ClinicalTrials.gov: N/A
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