EUCTR2020-002726-84-GB进行中（未招募）1 期
ong-Term Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment with SHP607 in Extremely Premature Infants - Footsteps
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Premacure AB
- 入组人数
- 382
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.Subject was randomized into Study SHP607-202. Subjects who were randomized, but did not complete Study SHP607-202 must be at least 12 months CA.
- •2.Written informed consents (and assents, if applicable) must be signed and dated by the subject's parent(s)/legally authorized representative(s) prior to any study-related procedures. The informed consent and any assents for underage parents must be approved by the institutional review board (IRB)/independent ethics committee (IEC).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 382
- •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
- •Subjects are excluded from the study if the subject or subject’s parent(s)/legally authorized representative(s) is/are unable to comply with the protocol or is/are unlikely to be available for long-term follow-up as determined by the investigator.
研究者
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