Switch From Tacrolimus to Cyclosporin in the Treatment of Recurrent Hepatitis C After Liver Transplantation

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In France, 50% of 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 and recurrence causes chronic liver disease in 50 to 80% of cases. The aim of this study is to assess the efficacy of cyclosporin on C virological response. Patients included in the Transpeg 1 study and non-responder or with a recurrent disease will be switched from their tacrolimus therapy to cyclosporin, in association with a 1 year peginterferon alfa-2a / ribavirin bitherapy. Efficacy will be assessed by the percentage of patients with a negative qualitative PCR after 19 months of cyclosporin treatment.

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

Details

• Lead Sponsor: Rennes University Hospital
• Collaborator: Novartis
• Treatments: Cyclosporine; Cyclosporins; Peginterferon alfa-2a; Ribavirin; Tacrolimus

Criteria

Inclusion Criteria:

• Adults aged 18 or over,

• Who had been included in the Transpeg 1 study,

• Non-responders after a three month peginterferon alfa-2a / ribavirin bitherapy or with a recurrent disease during the Transpeg 1 maintenance phase, whatever the randomization group (ribavirin or placebo),

• With a positive qualitative PCR at inclusion,

• With a METAVIR histologic score of 1 or more on the last biopsy (done within the 6 months preceding inclusion),

• Treated with tacrolimus for at least 6 months prior to inclusion,

• Having given a written informed consent.

Exclusion Criteria:

• Treatment with peginterferon or ribavirin within the 6 months preceding inclusion,

• Severe hepatocellular failure or decompensated cirrhosis,

• Acute graft rejection within the two months preceding inclusion, or signs of chronic rejection on the last biopsy, or retransplantation since inclusion in the Transpeg 1 study,

• Treatment with cyclosporin for more than 6 months during the 24 months preceding inclusion,

• Treatment with a mTOR inhibitor or with another investigational immunosuppressive drug,

• Positive serology for HIV or HBV,

• Cancer (or history of other malignancy during the last 5 years) except patients transplanted for hepatocellular carcinoma and basocellular or excised spinocellular carcinoma,

• Serious concomitant disease or acute or chronic disorder, other than the current transplant, treated with steroids,

• Serious cardiac pathology within the last 6 months,

• Women with ongoing pregnancy or breast-feeding,

• Serious chronic renal failure (creatinine clearance < 30 ml/mn),

• Haemoglobin < 10 g/dl, platelets < 50 000/mm3 or neutrophils < 1000 / mm3,

• Abnormal TSH values,

• Inability to cooperate or to communicate with the investigator,

• Contraindications to ribavirin, peginterferon alfa-2a or cyclosporin.