PRIMARY BILIARY CIRRHOSIS--UDCA-METHOTREXATE TREATMENT PROTOCOL

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This is a clinical trial of ursodeoxycholic acid (UDCA) and methotrexate (MTX) in the treatment of patients with primary biliary cirrhosis (PBC). UDCA appears to protect against the cytotoxic effects of endogenous bile acids that accumulate as a result of bile duct destruction. BMT is being shown to improve liver tests, symptoms and liver histology in a small number of precirrhotic patients with PBC. The mechanism of action is unknown but is felt to be related to anti-inflammatory-immunosuppressive effects of MTX. The current proposal will explore whether MTX improves the therapeutic effects. Fourteen of the 25 patients planned for study have been enrolled, and recruitment is still in process.