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/Ciclosporin Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Basiliximab
  • experimental
• Drug: Ciclosporin/ciclosporin microemulsion
  • active comparator

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Incidence of at least one biopsy proven acute rejection episode, graft loss or death within the first three months post-transplantation

Secondary Measures

• Incidence of biopsy proven acute rejection episodes within the first three months
• Incidence of steroid resistant rejection episodes within three and six months
• Death or graft loss (defined as being listed for a retransplantation) within three and six months after transplantation
• Incidence of bacterial, viral and fungal infections during six months
• Time of onset of a first biopsy proven acute rejection

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 and/or 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 16 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Director Novartis  

Overall Contact: Novartis 41613241111 

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00149890

Study ID Number: CCHI621ADE04

ClinicalTrials.gov Identifier: NCT00149890

Health Authority: Germany: Paul-Ehrlich-Institut