NCT02175615已完成不适用
PHARMACOLOGICAL PREDICTORS OF SUCCESSFUL CYCLOSPORINE ACUTE GRAFT VERSUS HOST DISEASE PROPHYLAXIS IN CHILDREN UNDERGOING HAEMATOPOIETIC STEM CELL TRANSPLANT
Lee Dupuis1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2010年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Relationship between CSA area-under-the-curve (AUC) prior to ENGRAFTMENT and severe aGVHD
研究概览
简要总结
The specific objectives of this study are:
Primary:
1)To determine the relationship between cyclosporine AUC achieved prior to engraftment and severe aGVHD (grade III and IV)
Secondary:
- To determine the relationship between individual concentration-time points achieved prior to engraftment and severe aGVHD (grade III and IV)
- To validate the previously developed LSS to determine cyclosporine AUC after IV administration at steady state and
- To describe the relationship between cyclosporine AUC and individual concentration-time points achieved prior to engraftment and other HSCT outcomes (clinically significant aGVHD (grade II to IV), hypertension, engraftment failure, relapse
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than 18 years of age
- •undergoing allogeneic myeloablative HSCT at one of the participating centres and
- •scheduled to receive cyclosporine for aGVHD prophylaxis
- •minimum patient weight:
- •6.4kg if < 6 months old or 7.2kg if > 6 months old
- •All patients or guardians will provide informed consent or assent as appropriate. Initial contact will be made by a member of the patient's current care team. Consent will be obtained by a co-investigator or the CTSU personnel.
排除标准
- •receipt of voriconazole or posaconazole within 14 days of the first cyclosporine dose or at any time until engraftment
结局指标
主要结局
Relationship between CSA area-under-the-curve (AUC) prior to ENGRAFTMENT and severe aGVHD
时间窗: Weekly for 7 weeks or until engraftment and for 100 days after HSCT
1)To determine the relationship between cyclosporine AUC achieved prior to engraftment and severe aGVHD (grade III and IV)
次要结局
未报告次要终点
研究者
Lee Dupuis
Dr. Lee Dupuis
The Hospital for Sick Children
研究点 (1)
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