Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
ConditionPrimary Biliary Cholangitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGilead Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be at least 18 years old.
Must have a confirmed prior diagnosis of primary biliary cholangitis (PBC)
Evidence of cirrhosis
CP Score A or B
Disqualifiers
Prior exposure to seladelpar
A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
Decompensated cirrhosis
Trial design
Design model
Parallel
Treatments tested in this trial
Seladelpar
DrugAdministered orally
Placebo
DrugAdministered orally
Treatment groups
402 Participants
are divided into 3 treatment groupsGroup A: SeladelparExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Open Label Extension PhaseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Overall Survival (OS)
Time from start of treatment to death from any cause.
Time frame
36 months2
Liver Transplant-Free Survival (LTFS)
Time from start of treatment to the first occurrence of liver-related death or liver transplantation.
Time frame
36 months3
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 months4
Time to Each Type of Adjudicated PBC Clinical Event: Model for End-Stage Liver Disease (MELD) score ≥ 15
Time frame
36 monthsSponsors and contacts
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Source ClinicalTrials.gov