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Infergen, Ribavirin & Avandia in Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin

NCT00207402 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-02-14

No results posted yet for this study

Summary

Genotype 1 hepatitis C virus (HCV) patients who did not respond (did not lose virus during treatment) or relapsed (virus went away on treatment but came back after treatment was stopped) after treatment with at least twelve weeks of a pegylated (long-acting) interferon and ribavirin will be considered for this study. There are two purposes to this study: first, to determine how rosiglitazone, a medicine used to treat diabetes, affects the HCV viral load; and second, to determine if treatment of insulin resistance with rosiglitazone prior to therapy for HCV will improve sustained virologic response (loss of virus that continues beyond six months after completion of HCV therapy) to HCV therapy.

Conditions

  • Hepatitis C

Interventions

DRUG

rosiglitazone

Infergen 15mcg/ d Avandia qd Ribavirin bid

Sponsors & Collaborators

  • InterMune

    collaborator INDUSTRY

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Stephen A Harrison, MD · Brooke Army Medical Center

  • Shane Mills, MD · Brooke Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2010-01-31
Completion
2010-07-31

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 NCT00207402 on ClinicalTrials.gov