MedTrace Logo

Study of Combivir for Patients With Primary Biliary Cirrhosis

NCT00490620 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2007-11-01

No results posted yet for this study

Summary

This is a proof of principal study to determine whether combination anti-viral therapy with Combivir impacts on hepatic biochemistry in patients with primary biliary cirrhosis

Conditions

  • Primary Biliary Cirrhosis

Interventions

DRUG

Combination antiviral therapy

Zidovudine 300mg and lamivudine 150mg BID for 6 months

DRUG

Placebo

placebo BID for 6 months

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Axcan Pharma

    collaborator INDUSTRY

  • University of Alberta

    lead OTHER

Principal Investigators

  • Andrew L Mason, MBBS MRCPI · University of Alberta

  • Bruce Bacon, MD · St. Louis University

  • Keith Lindor, MD · Mayo Clinic Foundation

  • James Neuberger, MD FRCP · University of Birmingham

  • Catherine Vincent, MD FRCPC · Université de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Completion
2007-04-30

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00490620 on ClinicalTrials.gov