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

ovartis Pharma GmbH0 个研究点目标入组 80 人开始时间: 2016年4月14日最近更新: 2016年4月18日

试验速览

暂无简介。

•- 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

•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.

发起方

ovartis Pharma GmbH