URSODEOXYCHOLIC ACID (UDCA) IN PRIMARY BILIARY CIRRHOSIS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease that frequently leads to liver failure and death. No accepted form of medical therapy currently exists for this disease. Accumulation of toxic bile acids may perpetuate liver damage in PBC. Ursodeoxycholic acid is a non-toxic bile acid with decreased detergent power that can be used to alter the composition of bile favorably when given orally. Study aims are to 1) compare effects of UDCA versus placebo on alkaline phosphatase, aspartate aminotransferase, bilirubin, albumin, immunoglobulin M, and prothrombin time; 2) evaluate effects on symptoms such as fatigue and pruritus; 3) determine effects on development or clinical progression of esophageal varices, ascites or edema, and encephalopathy; 4) determine effects on histologic changes at 2 years; 5) determine whether UDCA favorably affects survival or need for transplantation; 6) assess toxicity amp; determine safety. This study is complete and no further patients will be enrolled.