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Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis

NCT00004748 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2005-06-24

No results posted yet for this study

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.

Conditions

  • Liver Cirrhosis, Biliary

Interventions

DRUG

colchicine

DRUG

methotrexate

DRUG

ursodiol

Sponsors & Collaborators

  • Tufts Medical Center

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Marshall M. Kaplan · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1989-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004748 on ClinicalTrials.gov