The SUSTAIN Study

• Research type

  Research Study

• Full title

  A multi-center, randomized, open label, controlled study to compare the Sustained Virological Response during treatment with Neoral or tacrolimus in maintenance liver transplant recipients treated with pegylated interferon and ribavirin for recurrent Hepatitis C

• IRAS ID

  40084

• Contact name

  Marius Scholtz

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-010806-12

• ISRCTN Number

  N/A

• Research summary

  Hepatitis C (HCV) liver failure is the most common reason for liver transplantation. Recurrence of HCV infection post transplant is common resulting in an increase in morbidity, mortality and graft loss in this patient group. The choice of immunosuppression in terms of calcineurin inhibitor (CNI) can potentially be modified by the physician. Data are emerging to suggest that ciclosporin (CsA) may have a suppressive effect on HCV replication and allow better Sustained viral response (SVR) rates following treatment with standard antiviral therapy. This is an 80-week multinational study conducted in approximately 40-60 specialist liver transplant centers. 355 liver transplant recipients with recurrent hepatitis C patients will be randomly assigned to either Neoral (201) or tacrolimus (154). Before any tests or assessments for the study can be done, patients will be given a study information sheet and will be asked to sign a study consent form. Following randomization to tacrolimus or Neoral, patients will enter a run-in phase of 6-8 weeks for stabilization of the allocated CNI therapy. This will be followed by 72 weeks treatment with the allocated CNI. Antiviral treatment with Peg-IFN and ribavirin will be initiated at the end of the run-in period and will be administered for 48 weeks. Safety and efficacy will be assessed at all 10 study visits and will include: ?½ Blood samples to measure routine chemistry and hematology, levels of Hepatitis C virus and drug levels of Neoral or tacrolimus; ?½ Vital signs ?½ Pregnancy test ?½ Adverse events A liver biopsy will be performed at the beginning and end of the study to assess the level of liver fibrosis. There will also be an exploratory pharmacogenetic sub-study which will optional for patients. Patients willing to participate will be asked to sign a separate consent form. This study is being organised by Novartis Pharma Services AG, CH 4056, Basel. Switzerland

• REC name

  London - South East Research Ethics Committee

• REC reference

  10/H1102/6

• Date of REC Opinion

  25 Feb 2010

• REC opinion

  Further Information Favourable Opinion