Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation
The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation|
- Hepatitis C Viral Level [ Time Frame: 6 months after completion of interferon based therapy ] [ Designated as safety issue: No ]Undetectable or <100 COPIES/ML
|Study Start Date:||June 2004|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Tacrolimus
Patients receiving TAC were treated with a dose of 0.08-0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10-15 ng/ml for the first month post-transplant followed by 5-10 ng/ml thereafter. Immunosuppression was typically tapered to monotherapy (TAC alone) within 4-6 months of transplantation.
Other Name: Prograf
Active Comparator: Cyclosporine
Patients randomized to CsA had TAC discontinued and were treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml.
Other Name: Gengraf
This is a randomized, single-center controlled study comparing two different immunosuppression regimens (CsA and TAC) in patients with recurrent HCV after LT undergoing antiviral therapy for HCV.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821587
|Principal Investigator:||Roberto J Firpi-Morell, MD||University of Florida|