Treatment of Recurrent Hepatitis C After Liver Transplantation (TRANSPEG)

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, France
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00151580
First received: September 8, 2005
Last updated: May 18, 2012
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Liver Transplantation
Hepatitis C
Drug: Ribavirin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Maintenance Treatment by Ribavirin to a Placebo, After an Initial One-year Treatment With Pegylated Interferon-α2a - Ribavirin Association in Hepatitis C Viral Recurrence After Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Negative viral PCR [ Time Frame: 30 months ]

Secondary Outcome Measures:
  • Histological improvement [ Time Frame: 30 months ]
  • Biological hepatic markers [ Time Frame: 30 months ]
  • Quality of life [ Time Frame: 30 months ]
  • Intensity, severity and delay to acute transplant rejection, histologically proven [ Time Frame: 30 months ]
  • Incidence of death or graft loss [ Time Frame: 30 months ]
  • Number of patients stopping the treatment and causes [ Time Frame: 30 months ]
  • Incidence of adverse events classically related to treatment [ Time Frame: 30 months ]
  • Incidence of adverse events possibly related to treatment [ Time Frame: 30 months ]

Enrollment: 200
Study Start Date: February 2002
Study Completion Date: July 2006
Arms Assigned Interventions
Experimental: 1
Ribavirin maintenance treatment
Drug: Ribavirin
18 months of oral ribavirin maintenance treatment
Placebo Comparator: 2 Drug: Placebo
18 months oral placebo treatment

Detailed Description:

Several therapeutic patterns have been described for the treatment of hepatitis C post-transplantation recurrence. A combination treatment associating interferon-α and ribavirin has shown some efficacy, but this efficacy has not been assessed yet in a placebo-controlled double-blind clinical trial. In our study, all included transplanted patients will be treated during 1 year with interferon-α and ribavirin. At the end of this period, they will be randomized to receive a maintenance treatment with ribavirin or a placebo for 1 additional year. Efficacy will be assessed on virological response after 30 months of treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First liver transplantation or retransplantation in the month after initial transplantation
  • Patients aged over 18 years
  • Post-hepatitis C cirrhosis
  • Equilibrated immunosuppressive treatment
  • Positive PCR for hepatitis C virus
  • Liver biopsy between 6 months and 5 years after the transplantation with a fibrosis Metavir score at least F1
  • Hemoglobin ≥ 10 g/dl
  • Platelet count ≥ 50.000/mm3
  • Normal TSH value
  • Serum creatinine < 200µmol/l
  • Informed written consent

Exclusion Criteria:

  • Chronic rejection
  • Acute rejection at inclusion
  • Multi-visceral transplantation
  • Renal or cardiac failure, severe sepsis
  • Uncontrolled diabetes
  • Positive serology for hepatitis B or HIV at inclusion
  • EBV virus replication at inclusion
  • Hepatocellular carcinoma at inclusion
  • Cirrhosis with a fibrosis Metavir score F4 at inclusion
  • Inclusion in another clinical trial less than one month ago
  • Pregnancy
  • Contra-indication to ribavirin or interferon
  • History of or current psychiatric troubles
  • Thyroid disease uncontrolled by treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151580

Locations
France
Service d'Hépatologie - Hôpital Jean Minjoz
Besancon, France, 25030
Service de Chirurgie Digestive - Groupe Hospitalier Pellerin-Tripode
Bordeaux, France, 33000
Service d'Hépatogastroentérologie - Hôpital Beaujon
Clichy, France, 92110
Service d'Hépatologie et Gastroentérologie - Hôpital Henri Mondor
Créteil, France, 94010
Service des Maladies de l'Appareil Digestif - CHRU Claude Huriez
Lille, France, 59037
Service de Chirurgie Générale - Hôpital Edouard Herriot
Lyon, France, 69437
Médecine Digestive - Hôtel Dieu
Lyon, France, 69288
Chirurgie Générale - Hôpital de la Conception
Marseille, France, 13385
Service d'Hépaogastroentérologie - Hôpital Saint Eloi
Montpellier, France
Chirurgie Viscérale et Digestive -Hôpital de l'Archet
Nice, France, 06202
Service Hépato-gastroentérologie - Hôpital Saint Antoine
Paris, France, 75571
Service de Chirurgie Générale et Digestive - Hôpital Cochin
Paris, France, 75679
Département de Chirurgie Viscérale- Hôpital Pontchaillou
Rennes, France, 35033
Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre
Strasbourg, France, 67098
Hôpital de Rangueil
Toulouse, France, 31403
Centre Hépato-biliaire - Hôpital Paul Brousse
Villejuif, France
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
Principal Investigator: Karim Boudjema, MD, PhD CHU Rennes
Principal Investigator: Yvon Calmus, MD AP-HP Hôpital Cochin
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00151580     History of Changes
Other Study ID Numbers: AFSSAPS 010588, PHRC/00-02, CIC0203/049
Study First Received: September 8, 2005
Last Updated: May 18, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Hepatitis C
Viral recurrence
Ribavirin / Interferon

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014