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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
402
Administered orally
Administered orally
Event Free Survival (EFS)
EFS is defined as measured by the time from start of treatment to the first occurrence of any of the following clinical events: 1. Death by any cause 2. Liver transplantation 3. MELD score ≥15 4. Ascites requiring treatment 5. Hospitalization for any of the following 1. Esophageal or gastric variceal bleeding 2. Hepatic encephalopathy 3. Spontaneous bacterial peritonitis
Time frame: 36 months
Overall Survival (OS)
Time from start of treatment to death from any cause.
Time frame: 36 months
Liver Transplant-Free Survival (LTFS)
Time from start of treatment to the first occurrence of liver-related death or liver transplantation.
Time frame: 36 months
Time to Hospitalization
Time from start of treatment to the first occurrence of hospitalization for qualifying Primary biliary cholangitis (PBC) clinical events
Time frame: 36 months
Time to Each Type of Adjudicated PBC Clinical Event: Model for End-Stage Liver Disease (MELD) score ≥ 15
Time frame: 36 months
Time to Each Type of Adjudicated PBC Clinical Event: Ascites Requiring Treatment
Time frame: 36 months
Gilead Clinical Study Information Center
CONTACT
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