NCT00238901CompletedPhase 3
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)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 194
- Primary Endpoint
- 12-month cumulative incidence of post-surgical graft loss and death
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing first cadaver liver transplant Patients receiving an AB0 identical or compatible graft HCV+ patients (serology test within the last 12 months)
Exclusion Criteria
- •Antiretroviral prophylactic treatment post-transplant Serological markers positive for Hepatitis B surface Antigen and Human Immunodeficiency Virus Recipients of a split liver transplant Other protocol-defined inclusion/exclusion criteria applied
Outcomes
Primary Outcomes
12-month cumulative incidence of post-surgical graft loss and death
Secondary Outcomes
- 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.
Investigators
Similar Trials
Completed
Phase 3
Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver TransplantHepatitis CNCT00466219University Hospital, Geneva25
Recruiting
Phase 2
Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular CarcinomaLiver TransplantHepatocellular Carcinoma RecurrentSystemic TreatmentNCT06254248Assistance Publique - Hôpitaux de Paris50
Unknown
Not Applicable
Study of the Role of Dendritic Cells in the Recurrence of Hepatitis C After Liver Transplantation. Analysis of Hepatitis C Virus (HCV) Quasispecies Evolution.HCV InfectionNCT00213707University Hospital, Strasbourg, France30
Unknown
Not Applicable
Prevention of Graft Reinfection After Liver Transplantation With Anti HCV Monoclonal Antibodies Identified in Chronically Infected Patients or in Patients With Resolved Hepatitis CHepatitis CNCT00638144University Hospital, Strasbourg, France300
Withdrawn
Phase 4
Orthotopic Liver Transplant (OLT) Recipients With Hepatitis C Virus (HCV) Under Preemptive TreatmentHepatitis CNCT00167557The University of Texas Health Science Center, Houston