Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149890
Status:
COMPLETED
Last Update Posted:
2011-09-22
First Post:
2005-09-06
Brief Title:
Efficacy and Safety of Basiliximab CyclosporineCyclosporine Microemulsion and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Multicenter Open-label Randomized Two Arm Study to Investigate the Efficacy and Safety of a Therapy Avoiding Intraoperative Steroids in Combination With Basiliximab CyclosporineCyclosporine Microemulsion and Steroids in Pediatric de Novo Liver Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Systemic infection is still a major concern in young children with liver transplantation The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids another class of immunosuppressive drugs given in combination with basiliximab cyclosporine and steroids in pediatric de novo liver transplant recipients The treatment is compared to the same treatment regimen including intraoperative steroids with respect to rejection episodes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None