Treatment of Recurrent Hepatitis C After Liver Transplantation

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Collaborators: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS); Ministry of Health, France
• Treatments: Interferons; Ribavirin

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