• 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

• 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.

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.

• Liver Transplantation
• Infection

• Drug: Basiliximab
• Drug: Ciclosporin/ciclosporin microemulsion

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.