EUCTR2019-000337-39-GB进行中（未招募）1 期
An Open-Label Safety, Tolerability, and Efficacy Study of Eteplirsen inPatients with Duchenne Muscular Dystrophy Who Have Completed Study4658-102
Sarepta Therapeutics, Inc0 个研究点目标入组 15 人开始时间: 2019年4月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- Male
入选标准
- •1. Patient has successfully completed 96 weeks of treatment in Study
- •4658-102.
- •2. Parent(s) or legal guardian(s) who is/are able to understand and
- •comply with the study requirements.
- •3. Patient and/or their parent(s)/legal guardian(s) are willing and able
- •to provide signed informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •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
- •1. Patient has a prior or ongoing medical condition that, in the
- •Investigator's opinion, could adversely affect the safety of the patient, or
- •make it unlikely that the course of treatment or follow-up would be
- •completed, or impair the assessment of study results.
研究者
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