ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

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ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Brief description of study

The purpose of this research study is to evaluate the long-term safety and tolerability of seladelpar in treating PBC patients. Primary Biliary cholangitis (PBC) is a serious, rare slowly progressive and potentially life – limiting autoimmune liver disease which impairs bile flow in the liver and results in liver injury and possible liver failure. This will be done by looking at how the drug affects PBC. Seladelpar is an investigational drug. Investigational means that the drug has not been approved by the United States Food and Drug Administration (FDA).

Clinical Study Identifier: s20-01566

ClinicalTrials.gov Identifier: NCT03301506

Principal Investigator: Ira M. Jacobson.

Other Investigators: Mary Christine Olson, Viviana Figueroa Diaz.

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