RESPONSE: A Placebo-controlled Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Brief description of study

The purpose of this study, which involves research, is to determine if an investigational drug, seladelpar,is safe and effective in treating patients with PBC compared to placebo (which looks like the study drug but is not active medication). This will be done by looking at how the drug affects your PBC, specifically looking at changes in your laboratory parameters, such as alkaline phosphatase (ALP), bilirubin, gammaglutamyl transferase (GGT), and other laboratory tests that are used to monitor the severity of your PBC and its prognosis. Seladelpar is an investigational drug. Investigational means that the drug has not been approved by regulatory authorities.


Clinical Study Identifier: s21-00044
ClinicalTrials.gov Identifier: NCT04620733
Principal Investigator: Ira M. Jacobson.


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