drugset / Trial / NCT00545402
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-11
- Primary completion
- 2011-07
- Completion
- 2011-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 2 g | Oral |
| Subject | Mycophenolate Mofetil | Small molecule | 3 g | Oral |
| Comparator | Prednisone | Other / unclassified | 5 mg | Oral |
| Background | Methylprednisolone | Other / unclassified | — | Intravenous |
| Background | Tacrolimus | Small molecule | — | — |
Indications
No indication recorded.