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Home > "L" Clinical Trials Conditions > Low-Dose Oral Methotrexate versus Colchicine for Primary Biliary Cirrhosis  Low-Dose Oral Methotrexate versus Colchicine for Primary Biliary Cirrhosis
Low-Dose Oral Methotrexate versus Colchicine for Primary Biliary Cirrhosis
For Condition: Liver Cirrhosis, Biliary
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , New England Medical Center
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
MarshallKaplan, Study Chair, New England Medical Center
Additional Information:
Study ID Numbers: 199/11664; NEMCH-454
Study Start Date: November 1989
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004748
Other Liver Cirrhosis, Biliary Studies:
1. Phase III Randomized Study of Ursodiol with vs without Methotrexate for Primary Biliary Cirrhosis
2. Ursodiol-Methotrexate for Primary Biliary Cirrhosis
3. Treatment of Cholestatic Pruritus With Sertraline
4. Pilot Study of Budesonide for Patients with Primary Sclerosing Cholangitis
5. Low-Dose Oral Methotrexate versus Colchicine for Primary Biliary Cirrhosis
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Low-Dose Oral Methotrexate versus Colchicine for Primary Biliary Cirrhosis
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