Sirolimus and Hepatitis C following Liver Transplantation V1

• Research type

  Research Study

• Full title

  A Multi-Centre Prospective Controlled Trial Comparing Calcineurin Inhibitor Monotherapy With Sirolimus Monotherapy in Hepatitis C Infected Patients with Hepatic Fibrosis Following Liver Transplantation

• Sponsor organisation

  Cambridge University NHS Foundation Trust

• Eudract number

  2008-000252-28

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Hepatitis C infection is the most common indication for a liver transplant in the Western World. Unfortunately, the infection often recurs in the transplanted graft and can cause scarring (fibrosis) in the transplanted liver and this can eventually cause the liver to fail and may necessitate a second transplant or death. Sirolimus is an immunosuppressant drug (anti-rejection) which is widely used in kidney transplants. Our experience suggests that Sirolimus might be better than standard anti-rejection drugs at preventing the scarring from recurrent Hepatitis C in the transplanted liver. In Cambridge, we have 10 years of experience using sirolimus successfully in liver transplants. We are proposing a trial where participants who have had a liver transplant, have been re-infected with Hepatitis C and have evidence of scarring are separated at random into 2 groups. The first group will be given their anti-rejection drugs as per normal, the second will be changed over to Sirolimus over a period of 2-4 weeks. These patients are already intensively monitored and part of this monitoring is routine liver biopsies. At the end of 2 years we will analyse the biopsies of these patients at the start of the study before being allocated into groups and at the end of the project. By comparing the groups we hope to be able to tell if Sirolimus is better than current medication at preventing scarring

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  08/H0304/92

• Date of REC Opinion

  7 Nov 2008

• REC opinion

  Further Information Favourable Opinion