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.
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
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
200
Service d'Hépatologie - Hôpital Jean Minjoz
Besançon, France
Service de Chirurgie Digestive - Groupe Hospitalier Pellerin-Tripode
Bordeaux, France
Service d'Hépatogastroentérologie - Hôpital Beaujon
Clichy, France
Service d'Hépatologie et Gastroentérologie - Hôpital Henri Mondor
Créteil, France
Service des Maladies de l'Appareil Digestif - CHRU Claude Huriez
Lille, France
Médecine Digestive - Hôtel Dieu
Lyon, France
Service de Chirurgie Générale - Hôpital Edouard Herriot
Lyon, France
Chirurgie Générale - Hôpital de la Conception
Marseille, France
Service d'Hépaogastroentérologie - Hôpital Saint Eloi
Montpellier, France
Chirurgie Viscérale et Digestive -Hôpital de l'Archet
Nice, France
...and 6 more locations
Negative viral PCR
Time frame: 30 months
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
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