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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014