Long-Term Follow-up of Subjects Who Were Treated With SB-318, SB-913, or SB-FIX, for Targeted Genome Editing Into the Albumin Gene in the Liver
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 6
- 主要终点
- Long-term safety
研究概览
简要总结
Long-term follow-up of subjects who received SB-318, SB-913, or SB-FIX in a previous trial 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 10 years following exposure to SB-318, SB-913, or SB-FIX.
详细描述
Non-interventional, multi-center, long-term follow-up (LTFU) study of subjects dosed with SB-318 in the clinical study SB-318-1502, SB-913 in the clinical study SB-913-1602, and SB-FIX in clinical study SB-FIX-1501. All subjects dosed in the studies and 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 10 years following exposure to the respective investigational products.
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 SB-318 under Study Protocol SB-318-1502, SB-913 under Study Protocol SB-913-1602, or SB-FIX under Study Protocol SB-FIX-1501
- •Subjects who have provided consent to participate in the LTFU study.
排除标准
- •Unable to comply with study visit schedule or study visit procedures.
- •Any other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for participation in the study.
研究组 & 干预措施
Subjects who received SB-913
Subjects who received SB-913 in clinical study SB-913-1602.
干预措施: SB-913 (Biological)
Subjects who received SB-318
Subjects who received SB-318 in clinical study SB-318-1502
干预措施: SB-318 (Biological)
Subjects who received SB-FIX
Subjects who received SB-FIX in clinical study SB-FIX
干预措施: SB-FIX (Biological)
结局指标
主要结局
Long-term safety
时间窗: 10 years
Long-term safety of SB-318, SB-913, and SB-FIX by assessment of any newly-diagnosed or worsening of existing medical conditions.
次要结局
未报告次要终点