Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids

A Multicenter, Open-label, Randomized, Two Arm Study to Investigate the Efficacy and Safety of a Therapy Avoiding Intraoperative Steroids in Combination With Basiliximab, Cyclosporine/Cyclosporine 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, 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.

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
• Fulminant hepatic failure
• Autoimmune hepatitis
• Primary sclerosing cholangitis
• Severe acute systemic infections
• Hepatitis B surface antigen/HCV/HIV positive
• Known contraindication to intravenous (i.v.) or per os (orally) (p.o.) cyclosporine or corticoids
• Non-ability to comply with the protocol
• Relevant abnormal physical or laboratory findings within 2 weeks of inclusion
• Relevant severe allergy, hypersensitivity to basiliximab or similar drugs
• History/presence of relevant malignancy
• Pregnancy/breastfeeding
• Use of any investigational or immunomodulatory/immunosuppressive drug within 4 weeks prior to transplantation.