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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients undergoing primary orthotopic liver transplantation (whole organ or split liver or reduced size)
- •Cadaveric or living donor (related or unrelated)
排除标准
- •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.
研究组 & 干预措施
With Intraoperative Steroids
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
干预措施: Basiliximab (Drug)
With Intraoperative Steroids
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
干预措施: Cyclosporine/cyclosporine microemulsion (Drug)
With Intraoperative Steroids
Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
干预措施: Steroid (Drug)
Without Intraoperative Steroids
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
干预措施: Basiliximab (Drug)
Without Intraoperative Steroids
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
干预措施: Cyclosporine/cyclosporine microemulsion (Drug)
Without Intraoperative Steroids
No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
干预措施: Steroid (Drug)
结局指标
主要结局
Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation
时间窗: 3 months after treatment
Graft loss is defined as being listed for a re-transplantation. The analysis was based on the locally performed biopsy assessments. Generally, patients not experiencing a relevant event (i.e., acute rejection, graft loss or death) were censored with the last visit date.
次要结局
- Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months(3 months)
- Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months(3 and 6 months)
- Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation(3 months and 6 months)
- Number of Participants With Bacterial, Viral and Fungal Infections During Six Months(6 months)
- Time of Onset of a First Biopsy Proven Acute Rejection(6 months)
- Percentage of Participants With Treatment Failure Within Three and Six Months(3 and 6 months)