Ursodiol-Methotrexate for Primary Biliary Cirrhosis

NCT00006168 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2010-01-13

No results posted yet for this study

Summary

The major thrust is to determine whether treatment of patients with Primary Biliary Cirrhosis (PBC) with Ursodiol (Ursodeoxycholic Acid-UDCA) plus methotrexate (MTX) is more effective than treatment with UDCA alone.

Conditions

  • Liver Cirrhosis, Biliary

Interventions

DRUG

Methotrexate

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
20 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-01-31
Completion
2004-03-31

Countries

  • United States

Study Locations

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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 NCT00006168 on ClinicalTrials.gov