drugset / Trial / NCT01150097
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
RandomizedParallel-groupOpen-labelTreatment
Summary
The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).
Timeline
- Start
- 2010-03-31
- Primary completion
- 2013-05-03
- Completion
- 2013-05-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 1 mg | — |
| Subject | Tacrolimus | Small molecule | — | — |
Indications
No indication recorded.