drugset / Trial / NCT00149890
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2004-03
- Primary completion
- 2009-03
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prednisolone | Other / unclassified | 1 mg/m2 | Intravenous |
| Background | Basiliximab | Monoclonal antibody | 10 mg | Intravenous |
| Background | Basiliximab | Monoclonal antibody | 20 mg | Intravenous |
| Background | Cyclosporine | Peptide | 100 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 1 mg/m2 | Oral |