Treatment of Recurrent Hepatitis C After Liver Transplantation (TRANSPEG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00151580
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : May 21, 2012
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

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Hepatitis C Drug: Ribavirin Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2002
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: 1
Ribavirin maintenance treatment
Drug: Ribavirin
18 months of oral ribavirin maintenance treatment

Placebo Comparator: 2 Drug: Placebo
18 months oral placebo treatment

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00151580

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
Médecine Digestive - Hôtel Dieu
Lyon, France, 69288
Service de Chirurgie Générale - Hôpital Edouard Herriot
Lyon, France, 69437
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)
Principal Investigator: Karim Boudjema, MD, PhD CHU Rennes
Principal Investigator: Yvon Calmus, MD AP-HP Hôpital Cochin

Publications: Identifier: NCT00151580     History of Changes
Other Study ID Numbers: AFSSAPS 010588
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: November 2007

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

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