Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Disposition of ATG After a 7.5 mg/kg/Course
研究概览
简要总结
This study will describe the pharmacokinetic disposition of biologically active rabbit anti-thymocyte globulin (rATG) after a consistent dose of 7.5 mg/kg/course given as part of the conditioning regimen in children undergoing hematopoeitic stem cell transplantation (HSCT).
详细描述
Allogeneic hematopoeitic stem cell transplantation (HSCT) is a therapeutic option for patients with malignancies as well as metabolic and genetic diseases. Conditioning regimens given prior to donor cell infusion aim to ablate the recipient bone-marrow, to allow engraftment of the stem-cells infused, and to prevent acute versus host disease (aGVHD). Anti-thymocyte globulin (ATG) is one of the immunosuppressive drugs given as a preparative regimen for HSCT. Subjects will be given an ATG infusion daily for 3 days prior to HSCT and serum levels will be collected, as per schedule, with the last sample taken +100 days post-HSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who are scheduled to receive ATG 2.5mg/kg/day for 3 days as part of the preparative regimen for HSCT, as determined by the responsible HSCT physician.
- •Written, informed consent
排除标准
- •Hypersensitivity to rabbit proteins or to any product excipients
- •Active acute or chronic infections, which would contraindicate any additional immunosuppression
- •Known pregnancy or breastfeeding
研究组 & 干预措施
Thymoglobulin
Thymoglobulin 7.5 mg/kg/course prior to HSCT
干预措施: Thymoglobulin (rATG) (Biological)
结局指标
主要结局
Pharmacokinetic Disposition of ATG After a 7.5 mg/kg/Course
时间窗: 100 days
ATG pharmacokinetic parameters were estimated using a noncompartmental model. Maximum Observed Concentration (Cmax) of ATG After a 7.5 mg/kg/Course was measured
次要结局
未报告次要终点
研究者
Tal Schechter-Finkelstein
Staff Physician
The Hospital for Sick Children