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Interest of Ribavirin in the Maintenance Treatment of Liver Fibrosis Using Low Dose Pegylated Interferon alpha2b in Patients With Chronic Hepatitis C Non Responders to Previous Antiviral Therapy.

NCT00323804 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2014-09-04

No results posted yet for this study

Summary

Patients with chronic hepatitis C who did not respond to previous antiviral treatment develop liver fibrosis leading to cirrhosis. Maintenance low dose pegylated interferon therapy of fibrosis is currently under investigation in large multicenter trials. The aim of our study is to assess if peginterferon alpha2b plus ribavirin is more efficient than peginterferon alpha2b alone. 454 patients will be randomized between the 2 arms and the efficacy will be assessed, after 3 years of treatment, on Metavir liver fibrosis score improvement.

Conditions

  • Hepatitis C, Chronic
  • Liver Fibrosis

Interventions

BIOLOGICAL

Peginterferon alfa-2b

PegIFN alfa 2b in addition to ribavirin or ribavirin-placebo, from day 0 to M36

DRUG

Ribavirin

Ribavirin in addition to PegIFN alfa 2b, from day 0 to M36

DRUG

Ribavirin-Placebo

Ribavirin-placebo in addition to PegIFN alfa 2b, from day 0 to M36

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Rennes University Hospital

    collaborator OTHER

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Dominique Guyader, MD, PhD · CHU Rennes

  • Eric Bellissant, MD, PhD · CHU Rennes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2013-02-28
Completion
2013-03-31

Countries

  • Belgium
  • France

Study Locations

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Entities

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 NCT00323804 on ClinicalTrials.gov