drugset / Trial / NCT01150097

Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients

NCT01150097

Phase 3 Completed 284 enrolled Novartis Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 1 mg
Subject Tacrolimus Small molecule

Indications

No indication recorded.