A 5-year Longitudinal Observational Study of Patients with Primary Biliary Cholangitis

Brief description of study

This study will examine subjects with biliary cholangitis (PBC) which is a chronic, or long-term, disease of the liver characterized by damaged bile ducts due to inflammation. Bile is a digestive liquid that is made in the liver that helps the small intestines digest fats and fatty vitamins. The goal of this research study is to observe any treatment for PBC in a large number of people in a "real life" setting. Currently, there are 2 specific drugs, Ocaliva™ and ursodeoxycholic acid (UDCA), approved by the FDA (the Food and Drug Administration, the branch of federal government that approves new drugs) to treat PBC. In the future, there may be additional FDA-approved drugs to treat PBC. Researchers are interested in observing how these treatments,lifestyle changes, and counseling work in patients who are treated by their doctors in routine practice. Any treatments for PBC will be chosen by the subjects and their doctor. This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a biospecimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.

Clinical Study Identifier: s18-00627

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