A 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

Condition(s) targeted: Liver Transplantation; Infection

Intervention: Basiliximab (Drug); Ciclosporin/ciclosporin microemulsion (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

Overall contact:
Novartis, Phone: 41613241111

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.

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

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

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

Secondary outcome:

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

Minimum age: N/A. Maximum age: 16 Years. Gender(s): 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 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.

Novartis, Phone: 41613241111

Novartis Investigational Site, Various Cities, Germany; Recruiting
Novartis, Phone: 41613241111

Starting date: March 2004
Ending date: August 2008
Last updated: December 1, 2008