A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
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.