EUCTR2014-000499-24-IT进行中（未招募）不适用
Follow-up Study to Assess Long-Term Safety and Outcomes in Infants Born to Mothers Partecipating in Retosiban Treatment Studies - NA
GLAXOSMITHKLINE S.P.A.0 个研究点目标入组 330 人开始时间: 2015年5月14日最近更新:
适应症
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
- 330
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
- •Mother is randomly assigned and dosed (retosiban or comparator) in 1
- •of the Phase III retosiban clinical studies.
- •2.Infant is alive at 28 days post EDD.
- •3.Written informed consent is obtained from the parent(s) or legal
- •guardian(s) of the infant.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 330
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •All infants who meet the inclusion criteria will be eligible to enroll in the study. There are no formal exclusion criteria for participation.
研究者
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