Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis
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|ClinicalTrials.gov Identifier: NCT00004748|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus colchicine and ursodiol in patients with primary biliary cirrhosis (PBC).
II. Determine the optimum dose and duration of MTX treatment.
III. Investigate the role of fibrogenic cytokines (FC) in PBC pathogenesis and the effect of treatment on FC production.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis, Biliary||Drug: colchicine Drug: methotrexate Drug: ursodiol||Phase 3|
This is a randomized, double-blind study. Patients are stratified by prior/concurrent medical management.
Patients in the first group are treated with oral methotrexate 3 times a week and a daily oral placebo.
Patients in the second group are treated with daily oral colchicine and an oral placebo 3 times a week.
Therapy continues for 10 years. Beginning year 2, daily oral ursodiol is administered to all patients. Patients with disease progression are crossed to the alternate group or undergo liver transplantation if clinically indicated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase III Randomized, Double-Blind, Placebo-Controlled Study of Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis|
|Study Start Date :||November 1989|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004748
|Study Chair:||Marshall M. Kaplan||Tufts Medical Center|