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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Tufts Medical Center |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004748 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis |
| Estimated Enrollment: | 90 |
| Study Start Date: | November 1989 |
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| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
| Study ID Numbers: | 199/11664, NEMCH-454 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004748 History of Changes |
| Health Authority: | United States: Federal Government |
|
cirrhosis gastrointestinal disorders primary biliary cirrhosis rare disease |
|
Antimetabolites Liver Diseases Biliary Cirrhosis Immunologic Factors Gastrointestinal Diseases Fibrosis Cholestasis Rare Diseases Antimitotic Agents Liver Cirrhosis Folic Acid Antagonists Immunosuppressive Agents |
Primary Biliary Cirrhosis Ursodeoxycholic Acid Folic Acid Cholestasis, Intrahepatic Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Tubulin Modulators Methotrexate Colchicine Antirheumatic Agents Liver Cirrhosis, Biliary |
|
Antimetabolites Liver Diseases Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Cholestasis Fibrosis Antineoplastic Agents Physiological Effects of Drugs Liver Cirrhosis Reproductive Control Agents Gout Suppressants Pathologic Processes Cholestasis, Intrahepatic Biliary Tract Diseases |
Therapeutic Uses Abortifacient Agents Methotrexate Colchicine Dermatologic Agents Liver Cirrhosis, Biliary Nucleic Acid Synthesis Inhibitors Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Digestive System Diseases |
