NCT01135797已完成不适用
Retrospective Safety Survey In Patients Included In Phase I-II NV1FGF Clinical Trials
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Incidence of Deaths
研究概览
简要总结
The objective of this study is to collect retrospectively long term safety data in patients who have participated in the previous phase I-II trials conducted with the compound.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of Deaths
时间窗: From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake
Including all causes of deaths
Incidence of safety events of interest
时间窗: From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake
Safety events of interest when gene therapy is used i.e. development of any new/recurrent cancer, immunogenicity reactions
次要结局
未报告次要终点
研究者
研究点 (1)
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