TCTR20190528003已完成未知
A Pilot Therapeutic Drug Monitoring of Intravenous Busulfan in Thai Children Undergoing Hematopoietic Stem Cell Transplantation
Faculty of Medicine, Mahidol University, Thailand0 个研究点目标入组 10 人开始时间: 2019年5月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1 Years 至 18 Years（—）
- 性别
- All
入选标准
- •Pediatric patients undergoing allogeneic HSCT were enrolled in this study.
- •-The age range was from one year after birth to less than 18 years.
- •-The eligibility criteria are the patients must have adequate organ system function (cardiac, pulmonary, renal, and hepatic systems). That are, serum creatinine < 2 times of the upper limit of normal (ULN) values, serum total bilirubin < 1.5 times of the ULN, and AST and ALT < 3 times of the ULN.
- •-Histocompatibility was determined by DNA typing with intermediate- or high-resolution in class I (A, B, C) and II (DR, DQ) for 10 loci, using standard technique.
- •-The protocol and informed consent forms were approved by institutional review boards, Mahidol University, with full compliance of international Guidelines for Human Research Protection, such as Declaration of Helsinki, The Belmont Report, CIOMS Guidelines and the International Conference on Harmonization in Good Clinical Practice (ICG-GCP).
- •-Written consent or assent in children were informed before they were enrolled in this study.
排除标准
- •Patients previously undergoing HSCT were excluded.
研究者
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