Conditions: Liver Transplantation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 293
Healthy volunteers: no

Brief summary:
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: mycophenolate mofetil [CellCept] intervention 2: Tacrolimus intervention 3: Cyclosporine intervention 4: Sirolimus
Intervention descriptions: intervention 1: 1-1.5 g orally or intravenously twice daily intervention 2: As prescribed, for 12 months intervention 3: As prescribed, for 12 months intervention 4: 2-4 mg orally once daily for 9-11 months

Protocol document: