2023-503293-21-00招募中3 期
Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment with Romosozumab in Children and Adolescents with Osteogenesis Imperfecta
Amgen Inc.1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2026年2月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
To evaluate the safety of romosozumab in participants with osteogenesis imperfecta (OI) that have completed Study 20200105, regardless of whether they received investigational product (romosozumab) until the last protocolspecified dose or ended investigational product early
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Safety follow-up period
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •101 Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
- •101 Participant’s legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent, and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- •102 Participant was randomized to the romosozumab arm and completed Study 20200105 through the Month 15 Visit, regardless of whether they received investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early.
排除标准
- •201 Currently receiving treatment in another investigational device or drug study, or less than 2 years since ending treatment on another investigational device or drug study(ies) with the exception of Study
- •Other investigational procedures while participating in this study are excluded.
- •202 Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator’s knowledge.
结局指标
主要结局
Adverse events
Adverse events
次要结局
未报告次要终点
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (1)
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