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Treatment of Recurrent Hepatitis C After Liver Transplantation

NCT00151580 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-05-21

No results posted yet for this study

Summary

In France, 50% of the hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after transplantation. This recurrence usually causes chronic liver disease, in 50 to 80% of the patients. The interest of a long-term treatment with ribavirin alone after transplantation has not been clearly demonstrated. The objective of our study is to evaluate the efficacy of ribavirin as a maintenance treatment after a one year interferon-α / ribavirin therapy on hepatitis C recurrence in the transplanted liver.

Conditions

  • Liver Transplantation
  • Hepatitis C

Interventions

DRUG

Ribavirin

18 months of oral ribavirin maintenance treatment

DRUG

Placebo

18 months oral placebo treatment

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • ANRS, Emerging Infectious Diseases

    collaborator OTHER_GOV

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Karim Boudjema, MD, PhD · CHU Rennes

  • Yvon Calmus, MD · AP-HP Hôpital Cochin

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Completion
2006-07-31

Countries

  • France

Study Locations

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Entities

Drugs

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 NCT00151580 on ClinicalTrials.gov