ITX 5061 in Liver Transplant Recipients

• Research type

  Research Study

• Full title

  Phase I study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients with HCV infection

• IRAS ID

  52360

• Eudract number

  2010-020358-32

• ISRCTN Number

  Awaited

• Research summary

  Hepatitis C virus (HCV) infection is common and affects up to 0.5% of the UK population. In many of those infected liver disease progresses to liver failure and liver cell cancer. Current treatments can only cure about 50% of those individuals affected and many patients therefore have progressive disease. Consequently HCV infection is a leading indication for liver transplantation. HCV infection however recurs in the transplanted liver, progresses more rapidly, and is a major cause of transplant failure. New strategies to combat recurrent infection are therefore urgently required. ITX 5061 has been shown to be effective in preventing HCV entry in to liver cells in the laboratory and has been shown to be safe and generally well tolerated in patients. Since there is known to be massive entry of HCV particles into the liver in the first 48 hours after liver transplant this is the ideal setting to test this drug. We will test the safety of ITX 5061 in liver transplant recipients with HCV infection and determine whether there is any evidence of benefit of this treatment in this group. Patients will be allocated into two groups: (i) standard liver transplant care, and (ii) ITX 5061 for one week plus standard liver transplant care. All patients will have detailed monitoring of HCV viral load in the blood.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  10/H0301/36

• Date of REC Opinion

  5 Oct 2010

• REC opinion

  Further Information Favourable Opinion