drugset / Trial / NCT01598987

Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.

NCT01598987

Phase 3 Completed 56 enrolled Novartis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study was designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.

Timeline

Start
2012-10
Primary completion
2016-06
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 0.8 mg/m2
Subject Everolimus Small molecule 2 mg/m2
Background Cyclosporine Peptide
Background Tacrolimus Small molecule