EUCTR2021-005404-36-Outside-EU/EEA进行中(未招募)1 期
A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Japanese Pediatric Subjects with Short Bowel Syndrome Who Completed SHP633-302
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- Shire
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
- •- Informed consent by a parent or guardian prior to any study-related procedures.
- •- When applicable, informed assent (as deemed appropriate by the Institutional Review Board [IRB]) by the participant prior to any study-related procedures.
- •- Participant completed Study SHP633-302 (NCT02980666).
- •- Participant (and/or parent/guardian) understands and is willing and able to fully adhere to study requirements as defined in this protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 9
- •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
- •There are no exclusion criteria for this study.
研究者
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