Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis

This study has been completed.

Sponsor:

Collaborator:

Tufts Medical Center

Information provided by:

Office of Rare Diseases (ORD)

ClinicalTrials.gov Identifier:

NCT00004748

First received: February 24, 2000

Last updated: June 23, 2005

Last verified: December 2001

History of Changes

Purpose

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	Intervention	Phase
Liver Cirrhosis, Biliary	Drug: colchicine Drug: methotrexate Drug: ursodiol	Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

Drug Information available for: Methotrexate Colchicine

Genetic and Rare Diseases Information Center resources: Primary Biliary Cholangitis

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):


Estimated Enrollment:	90
Study Start Date:	November 1989

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004748

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Tufts Medical Center

Investigators


Study Chair:	Marshall M. Kaplan	Tufts Medical Center

More Information


ClinicalTrials.gov Identifier:	NCT00004748 History of Changes
Other Study ID Numbers:	199/11664 NEMCH-454
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005

Keywords provided by Office of Rare Diseases (ORD):


cirrhosis gastrointestinal disorders primary biliary cirrhosis rare disease

Additional relevant MeSH terms:


Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Pathologic Processes Liver Diseases Digestive System Diseases Cholestasis, Intrahepatic Cholestasis Bile Duct Diseases Biliary Tract Diseases Methotrexate Colchicine 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 Antimitotic Agents

ClinicalTrials.gov processed this record on September 19, 2017

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