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
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Eligibility criteria
Qualifiers
Must be at least 18 years old.
Must have a confirmed prior diagnosis of 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
Treatments tested in this trial
- Seladelpar
- Placebo
Treatment groups
318 Participants
are divided into 2 treatment groupsLocations
203Argentina
AES - AS - Glenny Corp. S.A. Buenos AiresC1430, Buenos Aires Argentina
Buenos Aires MáculaC1061, Buenos Aires Argentina
Centro de Investigación y Prevención CardiovascularC1061, Buenos Aires Argentina
Consultorios Médicos Dr. Doreski - PPDS1426, Buenos Aires Argentina
Sponsors and collaborators
Gilead Sciences
Lead sponsor
Source ClinicalTrials.gov