Long-Term Follow-up of Fabry Disease Subjects Who Were Treated With ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 24
- 主要终点
- To evaluate long-term safety of ST-920
研究概览
简要总结
Long-term follow-up of subjects who received ST-920 in a previous trial (ST-920-201) and completed at least 52 weeks post-infusion follow-up in their primary protocol. Enrolled subjects will be followed for a total of up to 5 years following ST-920 infusion.
详细描述
Non-interventional, multi-center, long-term follow-up (LTFU) study of subjects dosed with ST-920 in the clinical study ST-920-201. All subjects dosed in the study who completed at least 52 weeks post-infusion follow-up in their primary protocol will be offered to participate. Subjects who enroll will be monitored for a total of up to 5 years following ST-920 infusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subjects who received ST-920 therapy in a separate parent trial
- •Subjects who have consented to participate in this LTFU study.
排除标准
- •This study has no exclusion criteria
研究组 & 干预措施
Subjects who received ST-920
Subjects who received ST-920 in a separate parent trial
干预措施: ST-920 (Biological)
结局指标
主要结局
To evaluate long-term safety of ST-920
时间窗: 4 years
To evaluate long-term safety of ST-920 by assessment of incidence and severity of adverse events (AEs)
次要结局
未报告次要终点