A Study to Investigate a Therapy Avoiding Intraoperative Steroids in Combination With Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients

• Conditions: iver Transplantation Infection; MedDRA version: 19.0Level: PTClassification code 10077116Term: Systemic infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.0Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-003528-29-Outside-EU/EEA
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-14
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- Pediatric patients undergoing primary orthotopic liver transplantation (whole organ or split liver or reduced size)
- Cadaveric or living donor (related or unrelated)

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified