Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis

Phase 3

Completed

• Conditions: Liver Cirrhosis, Biliary

• Registration Number: NCT00004784
• Lead Sponsor: National Center for Research Resources (NCRR)

Brief Summary

OBJECTIVES: I. Compare the effects of ursodiol (ursodeoxycholic acid), with and without methotrexate, on pruritus, incapacitation index, and serum markers of activity and severity in patients with primary biliary cirrhosis.

II. Compare the effects of these regimens on the development of ascites, encephalopathy, varices (or bleeding from pre-existing varices), histologic liver changes, transplantation, and survival.

III. Compare the toxicity and safety of each regimen.

Detailed Description

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and Ludwig histologic stage.

All patients are treated with ursodiol (ursodeoxycholic acid, UDCA) for 6 months. If entry criteria continue to be met, patients are randomly assigned to UDCA/methotrexate or UDCA/placebo.

Combination therapy continues for at least 5 years.

Study Timeline

• Study Start: 1994-01
• Study First Submitted: 2000-02-24
• Study First Submitted QC: 2000-02-24
• Study First Posted: 2000-02-25
• Status Verified: 2001-12
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified