NCT06112327Enrolling By Invitation不适用
Long-term Follow-up Study of Investigational Gene-editing Therapies in Participants with or At High Risk for Cardiovascular Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs) and other events of interest using CTCAE 5.0 to assess the long-term safety of gene-editing therapies.
研究概览
简要总结
LTF-001 is a long-term follow-up study of participants who received an investigational gene-editing therapy developed by the sponsor to evaluate the long-term effects of the investigational therapy. Participants will be followed for a total of 15 years after the first administration of the gene-editing 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs) and other events of interest using CTCAE 5.0 to assess the long-term safety of gene-editing therapies.
时间窗: up to 15 years
To assess the long-term safety of gene-editing therapies, the following will be assessed: Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs) and any CTCAE grade 3 or higher AEs.
次要结局
- Percent and absolute change from baseline of target biomarkers over time after administration of a gene-editing therapy.(up to 15 years)
- Percent and absolute change from baseline of lipid concentrations over time after administration of a gene-editing therapy.(up to 15 years)
研究者
研究点 (1)
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