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

Liver Transplant Recipient Clinical Trial

Official title: Extension Study to the Multicenter, Open-label, Randomized, Controlled Study CRAD001H2304 to Evaluate the Long-term Efficacy and Safety of Concentration-controlled Everolimus in Liver Transplant Recipient

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Liver Transplant Recipient

• NCT number: NCT01150097
• Study type: Interventional
• Source: Novartis
• Status: Completed
• Phase: Phase 3
• Start date: March 31, 2010
• Completion date: May 3, 2013