A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.

A Randomized, Open Label Study Comparing the Effect of CellCept With Therapeutic Drug Monitoring, Tacrolimus and a Corticosteroid-sparing Regimen Versus Fixed Dose CellCept, Tacrolimus and Corticosteroids Maintained up to 6 Months, on Acute Rejection and Safety in Liver Transplant Patients.

This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients. Patients will be randomized into one of two groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day 0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Inclusion Criteria:

• adult patients, >=18 years of age;
• recipient of a first orthotopic liver transplant.

Exclusion Criteria:

• history of organ transplants;
• patient receiving a multi-organ transplant;
• calculated creatinine clearance <=30mL/min before transplant;
• leukocyte count < 2000/mm3 at randomization;
• history of cancer within past 5 years, except for successfully treated basal cell or squamous cell cancer, or in situ cervical cancer;
• pregnant or breast-feeding females, or females of childbearing age not using effective contraception.