Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis
Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Cirrhosis, Biliary
Intervention: colchicine (Drug); methotrexate (Drug); ursodiol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Marshall M. Kaplan, Study Chair, Affiliation: Tufts Medical Center
Summary
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.
Clinical Details
Official title: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: November 1989
Last updated: June 23, 2005
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