Chronic Hepatitis C Clinical Trial
Official title:
Prospective, Open-label, Single Arm Pilot Study Evaluating the Effect on Virological Response of the Switch From Tacrolimus to Cyclosporin Associated With a Peginterferon Alfa-2a / Ribavirin Bitherapy, in Non-responder or With Recurrent VHC+ Disease Liver Transplanted Patients.
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.
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. A main factor determining the severity of recurrent
hepatitis C after transplantation may be immunosuppression. Thus optimization of
immunosuppressive regimens might be a key aspect to improve the prognosis of chronic
hepatitis C in transplanted patients. The two most frequently used immunosuppressive drugs
are cyclosporin and tacrolimus. However, it has been shown that virus replication could be
inhibited by cyclosporin, through the blockade of cyclophilins, decreasing hepatitis C viral
load and improving liver function. These effects were not found with tacrolimus.
The aim of our study is to assess the efficacy on C virological response of the switch from
tacrolimus to cyclosporin associated with a peginterferon alfa-2a / ribavirin bitherapy, in
non-responder or with a recurrent VHC+ disease liver transplanted patients.
Patients will receive a 19 month cyclosporin treatment, associated during 12 months with a
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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