To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
318
* 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.
One capsule daily for up to 36 months.
Event Free Survival (EFS)
EFS 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
Time from start of treatment to death from any cause.
Time frame: 36 months
Liver transplant-free survival
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 PBC clinical events
Time frame: 36 months
Time to Event Free Survival (EFS)
1. MELD score ≥15 2. Ascites requiring treatment
Time frame: 36 months
Gilead Clinical Study Information Center
CONTACT
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