Phase 3
N=77
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Liver Transplantation · Infection
Bottom Line
View on ClinicalTrials.gov: NCT00149890 ↗Enrolled (actual)
77
Serious AEs
53.3%
Results posted
Sep 2011
Primary outcome: Primary: Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation — 8; 15; 14; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Basiliximab (Drug); Cyclosporine/cyclosporine microemulsion (Drug); Steroid (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation |
8; 15; 14; 11; 22; 26 | — |
| SECONDARY Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months |
20; 26 | — |
| SECONDARY Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months |
2; 2; 2; 2 | — |
| SECONDARY Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation |
0.0; 2.6; 0.0; 2.6; 5.1; 2.6 | — |
| SECONDARY Number of Participants With Bacterial, Viral and Fungal Infections During Six Months |
16; 16; 15; 14; 10; 18 | — |
| SECONDARY Time of Onset of a First Biopsy Proven Acute Rejection |
1.93; 0.75 | — |
| SECONDARY Percentage of Participants With Treatment Failure Within Three and Six Months |
0.00; 4.17; 11.11; 7.14; 5.13; 5.26 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00149890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.