NCT06262399Enrolling By Invitation不适用
Long-Term Follow-Up of Subjects Treated With NTLA 2002
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Incidence of treatment-related Adverse Events (AEs); incidence of treatment-related Serious Adverse Events (SAEs); incidence of treatment-related Adverse Events of Special Interest (AESIs) defined per protocol
研究概览
简要总结
This is a follow-up study of subjects who received NTLA-2002 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
- 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 or -supported treatment protocol in which a complete or partial dose of NTLA-2002 was received.
- •A subject has provided informed consent for the LTFU study.
- •A subject is willing to attend study visits, complete protocol-required follow-up schedule, and comply with the study requirements.
排除标准
- 未提供
结局指标
主要结局
Incidence of treatment-related Adverse Events (AEs); incidence of treatment-related Serious Adverse Events (SAEs); incidence of treatment-related Adverse Events of Special Interest (AESIs) defined per protocol
时间窗: up to 15 years
次要结局
- Change from baseline in healthcare utilization for HAE attacks(up to 15 years)
- To evaluate the long-term efficacy of NTLA-2002 in previously treated subjects(up to 15 years)
- Change from baseline in QoL parameters as measured by the MOXIE Angioedema-QoL instrument.(up to 5 years)
- Change from baseline in consumption of on-demand HAE medications for reported HAE attacks(up to 15 years)
- Change from baseline in QoL parameters as measured by the EQ-5D-5L instrument.(up to 5 years)
- Change from baseline in QoL parameters as measured by the WPAI:GH instrument.(up to 5 years)
研究者
研究点 (7)
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