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This is a study evaluating the safety and efficacy of the study drug seladelpar in people with Primary Biliary Cholangitis (PBC). This will be done by looking at how the study drug seladelpar affects PBC and observing changes in the laboratory tests that are used to monitor the severity of PBC and its prognosis.
PBC is a chronic disease of the liver resulting from progressive destruction of bile ducts in the liver. Bile is a substance produced by the liver to facilitate digestion. In PBC, the bile ducts develop inflammation and causes liver damage, which may eventually lead to cirrhosis (liver scarring). In the early stages of PBC, people may experience itching.
Seladelpar is being developed to reduce the itchiness due to PBC and is considered to be investigational, meaning it is not approved by the U.S. Food and Drug Administration (FDA).
All participants will take a 10 mg tablet of seladelpar once daily.
Participation in this study will last for approximately 60 months (about 5 years) and participants will be compensated for their time.
1. Men and women who are 18 years of age and older.
2. Have been diagnosed with Primary Biliary Cholangitis (PBC)
Detailed eligibility reviewed when contacting the study team.