Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

PHASE4CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

Conditions
Hepatitis C
Interventions
DRUG

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.

DRUG

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.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

University of Florida

OTHER