EUCTR2021-006781-21-FR进行中（未招募）1 期
ong-term follow-up of patients with spinal muscular atrophy Treated with OAV101 IT or OAV101 IV in Clinical Trials
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Participants eligible for inclusion in this study must meet all of the following criteria:
- •1. Received OAV101 IT or OAV101 IV in a Phase I to IIIb clinical trial sponsored by AveXis, Novartis or Novartis Gene Therapies.
- •2. Patient/Parent/legal guardian willing and able to complete the informed consent process and comply with study procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 260
- •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
- •Score yes” on item 4 or item 5 of the suicidal ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or yes” on any item of the suicidal behavior section, except for the Non-Suicidal Self-Injurious Behavior” (item also included in the suicidal behavior section) if this behavior occurred in the past 2 years.
研究者
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