Treatment of Recurrent Hepatitis C After Liver Transplantation (TRANSPEG)

Rennes University Hospital

Status and phase: Completed; Phase 3

Conditions: Liver Transplantation; Hepatitis C

Treatments: Drug: Placebo; Drug: Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT00151580

CIC0203/049

PHRC/00-02

AFSSAPS 010588

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Ribavirin maintenance treatment

Treatment:

Drug: Ribavirin

2

Placebo Comparator group

Treatment:

Drug: Placebo