EUCTR2013-004642-41-GB进行中(未招募)不适用
Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Prospective study of understudied drugs in children
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 2,000 人开始时间: 2015年7月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 2,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Children and young people (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1306
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 175
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1) Failure to obtain consent/assent
- •2) Know pregnacy as determined via interview or testing if available
- •3) If a child, who is capable of assenting, does not give their assent, even if their parent does give their consent
- •4) Aged 16 or over with mental health issues
研究者
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