NCT05697861Enrolling By Invitation不适用
Long-Term Follow-Up of Subjects Treated With NTLA-2001
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 72
- 试验地点
- 5
- 主要终点
- Incidence of Treatment-related SAEs and Protocol-specified AESIs
研究概览
简要总结
This is a follow-up study of subjects who received NTLA-2001 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy.
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
- •A subject has completed or discontinued from an Intellia-sponsored clinical study in which a complete or partial dose of NTLA-2001 was received.
- •A subject has provided informed consent for the LTFU study.
排除标准
- 未提供
结局指标
主要结局
Incidence of Treatment-related SAEs and Protocol-specified AESIs
时间窗: up to 15 years
Long-term safety assessment of any treatment-related SAEs and protocol-specified AESIs
次要结局
- PD biomarkers for ATTR including serum TTR and serum prealbumin(up to 15 years)
研究者
研究点 (5)
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