Clinical trial NCT00149890: Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
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, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Transplantation
Infection
Keywords: pediatric
liver transplantation
Simulect
Basiliximab
ciclosporin microemulsion
steroid reduction
pediatric liver transplantation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 77
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 (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.


Eligibility 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
* 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.

Primary outcomes:
measure: Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months
timeFrame: 3 months
measure: Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months
timeFrame: 3 and 6 months
measure: Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation
timeFrame: 3 months and 6 months
measure: Number of Participants With Bacterial, Viral and Fungal Infections During Six Months
timeFrame: 6 months
measure: Time of Onset of a First Biopsy Proven Acute Rejection
timeFrame: 6 months
measure: Percentage of Participants With Treatment Failure Within Three and Six Months
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Various Cities
country: Germany
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: