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 recipients
- Registry ID
- EUCTR2009-017311-15
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE3
- Sponsor
- Novartis Pharma Services AG
- Start date
- 2010-03-12
- Completion date
- 2013-04-18
- Last update
- 2026-08-16
Conditions
- profilaxis del rechazo de aloinjertos hepáticos en los receptores de trasplante de hígado
- prophylaxis of liver allograft rejection in liver transplant recipients
- liver transplant
Summary
To evaluate at Month 36 & 48 post-transplantation: - renal function; - composite efficacy endpoint of graft loss and death; - composite efficacy endpoint of treated biopsy proven acute rejection (BPAR), graft loss, or death; - rates of progression of HCV related allograft fibrosis.
Locations
- , , Sweden
- , , Netherlands
- , , Italy
- , , Germany
- , , Hungary
- , , Spain
- , , UK
- , , Ireland
- , , Czechia
- , , Belgium
- , , France
View on source registry