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
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OBJECTIVES:
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 |
PROTOCOL OUTLINE:
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) |
Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |


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Ages Eligible for Study: | 0 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Biopsy proven primary biliary cirrhosis (PBC); Disproportionate increase in alkaline phosphatase; Positive antimitochondrial antibody test OR Symptoms consistent with PBC, e.g.: pruritus, fatigue, malaise, jaundice, elevated bilirubin
No clinically advanced PBC, i.e.: bilirubin greater than 10 mg/dL or albumin less than 2.5 g/dL, determined by 2 analyses 10 weeks apart; bleeding esophageal varices or congestive gastropathy; chronic hepatic encephalopathy; chronic ascites
--Prior/Concurrent Therapy-- No concurrent drugs associated with chronic liver disease
--Patient Characteristics--
Hematopoietic: WBC at least 2500 Platelets at least 100,000 (unless due to hypersplenism); Hematocrit at least 30%
Renal: No renal disease that could cause liver dysfunction
Other: No history of alcohol abuse; No other medical illness that might cause liver dysfunction, e.g., severe cardiac failure; No pregnant women

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 |
ClinicalTrials.gov Identifier: | NCT00004748 |
Other Study ID Numbers: |
199/11664 NEMCH-454 |
First Posted: | February 25, 2000 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | December 2001 |
cirrhosis gastrointestinal disorders primary biliary cirrhosis rare disease |
Liver Cirrhosis Liver Cirrhosis, Biliary Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases Cholestasis, Intrahepatic Cholestasis Bile Duct Diseases Biliary Tract Diseases Methotrexate Colchicine Ursodeoxycholic Acid Abortifacient Agents, Nonsteroidal Abortifacient Agents |
Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Gout Suppressants Tubulin Modulators |