Efficacy and Safety of Basiliximab in Hepatitis C Virus Positive Patients Undergoing Liver Transplantation
|ClinicalTrials.gov Identifier: NCT00238901|
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : September 1, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplant||Drug: Basiliximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||December 2002|
|Primary Completion Date :||July 2005|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238901