drugset / Trial / NCT00336817
A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of this study is to compare the safety and efficacy of Myfortic with CellCept in liver transplant patients. Myfortic and CellCept are both immunosuppressive (anti-rejection) drugs. CellCept is commonly used after liver transplantation but gastrointestinal (GI) side effects are very common, sometimes necessitating in its discontinuation. Myfortic is a new drug similar to CellCept, except it is enteric-coated. Our hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable effectiveness to CellCept.
Timeline
- Start
- 2006-11
- Primary completion
- 2008-11
- Completion
- 2008-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mycophenolate Mofetil | Small molecule | 500 mg | Oral |
| Comparator | Mycophenolate Mofetil | Small molecule | 1000 mg | Oral |
| Comparator | mycophenolic acid | Small molecule | 360 mg | Oral |
| Comparator | mycophenolic acid | Small molecule | 720 mg | Oral |