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Clinical Trial: A Multicenter, Open-Label, Randomized, Two Arm Study to Investigate the Efficacy and Safety of a Therapy Avoiding Intraoperative Steroids in Combination with Basiliximab, Ciclosporin/Ciclosporin Microemulsion, and Steroids in Pediatric De Novo Liver Trans
This study is currently recruiting patients.
Verified by Novartis December 2003
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Purpose
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, ciclosporin 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.
| Condition | Intervention | Phase |
|---|---|---|
| pediatric liver transplantation | Drug: Basiliximab, Ciclosporin/ciclosporin microemulsion, Steroids | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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, Ciclosporin/Ciclospirin Microemulsion, and Steroids in Pediatric De Novo Liver Transplant Recipients
Further Study Details:
Study start: March 2004
Eligibility
Ages Eligible for Study: up to 16 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- • Pediatric patients undergoing primary orthotopic liver transplantation (whole organ or split liver or reduced size) • Cadaveric or living donor (related or unrelated)
Exclusion Criteria:
- Patients who are recipients of multiple solid organ transplants or/and who have previously received transplanted organs If cold ischemia time of the transplanted organ is >12 hours Auxiliary liver transplant recipients
Other protocol-defined exclusion criteria may apply.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00149890
Novartis 41613241111
Switzerland
Novartis, Basel, Switzerland; Recruiting
Novartis 41613241111
Study chairs or principal investigators
Novartis, Study Director, Novartis
More Information
Study ID Numbers: CCHI621ADE04
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00149890
Health Authority: Germany: Paul-Ehrlich-Institut
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00149890
Health Authority: Germany: Paul-Ehrlich-Institut
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- NIH Pediatric Rheumatology Clinic (National Institute of Arthritis and Musculoskeletal and Skin Diseases)
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