Status:
COMPLETED
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Lead Sponsor:
Novartis
Conditions:
Liver Transplantation
Infection
Eligibility:
All Genders
Up to 16 years
Phase:
PHASE3
Brief Summary
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 (a...
Eligibility Criteria
Inclusion
- Pediatric patients undergoing primary orthotopic liver transplantation (whole organ or split liver or reduced size)
- Cadaveric or living donor (related or unrelated)
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00149890
Start Date
March 1 2004
End Date
March 1 2009
Last Update
September 22 2011
Active Locations (1)
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1
Novartis Investigational Site
Various Cities, Germany