Efficacy and Safety of Basiliximab in Hepatitis C Virus Positive Patients Undergoing Liver Transplantation
The natural history of HCV infection in liver transplant recipients may be accelerated when compared to that in patients with normal immune systems.
The objective of this trial is to assess the efficacy and safety of basiliximab, in combination with cyclosporin and MMF on the success rate of liver transplants for HCV related cirrhosis, in comparison with standard steroid treatment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Efficacy and Safety of Basiliximab in HCV+ Patients Undergoing Liver Transplantation, as Compared With Steroids, Both Given in Combination With Cyclosporine and Mycophenolate Mofetil (MMF)|
- 12-month cumulative incidence of post-surgical graft loss and death
- hepatitis C recurrence (see definition 3.5.2) at 6 and 12 months after transplant surgery.
- treated and biopsy proven acute rejection at 6 and 12 months after transplant surgery.
- graft survival and patient survival after treatment with either Simulect or steroids at 6 and 12 months.
- viral load (HCV-RNA) after treatment with Simulect or steroids at Baseline, Month 1 and 3 post transplantation.
|Study Start Date:||December 2002|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|