NCT02065011进行中（未招募）2 期
An Open-label Study to Determine the Long-term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- The incidence of adverse events
研究概览
简要总结
Primary Objective:
To evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome Type 1B
Secondary Objective:
To assess long-term safety and biological activity of SAR421869
详细描述
The total duration of study period is up to 15 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Provide signed and dated written informed consent (and if appropriate assent) and any locally required authorization eg, Health Insurance Portability and Accountability Act (HIPAA).
- •Must have been enrolled in protocol TDU
- •Must have received a subretinal injection of SAR421869
排除标准
- •Did not receive SAR421869 as part of the TDU13600 protocol.
研究组 & 干预措施
Long-term follow up
Other
Long-term follow up of patients who received SAR421869 in a previous study TDU13600
干预措施: Blood draw for the laboratory assessment (Drug)
结局指标
主要结局
The incidence of adverse events
时间窗: 15 years
The number and percentage of patients with treatment emergent adverse events
次要结局
- Delay in retinal degeneration(baseline to 15 years)
- Clinically important changes in ocular safety assessments(baseline to 15 years)
研究者
研究点 (2)
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