Specified Drug-use Survey of Leqvio for s.c. Injection (Familial Hypercholesterolaemia or Hypercholesterolaemia, CKJX839A11401)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 585
- 试验地点
- 107
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice
详细描述
Uncontrolled, central registration system, multicenter, special drug use-results surveillance.
This is a prospective, open-label, multicenter, single-arm observational study (non-interventional study: NIS) conducted only in Japan.
The survey will include patients with familial hypercholesterolaemia or hypercholesterolaemia who have received treatment with Leqvio. Patients who discontinued treatment with Leqvio before completing the 24-month observation period will be followed for safety until the date of the last dose of Leqvio plus 180 days or until 24 months after the first dose of Leqvio, whichever comes earlier.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who provided written informed consent to participate in this survey prior to the start of treatment with Leqvio.
- •Patients who received treatment with Leqvio as per the package insert.
排除标准
- •Patients who received treatment with a formulation containing the same ingredients as Leqvio in the past.
- •Patients participating in other interventional studies at the time of informed consent.
- •Patients planning to participate in other interventional studies during this survey.
研究组 & 干预措施
inclisiran
Patients prescribed with inclisiran
干预措施: inclisiran (Other)
结局指标
主要结局
Number of patients with adverse events
时间窗: Up to 24 months
To evaluate the long-term safety profile of Leqvio
Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions
时间窗: Up to 24 months
To evaluate the long-term safety profile of Leqvio
次要结局
- Percent change from baseline in LDL-C levels(Month 24)
- Number of patients with adverse events leading to discontinuation of treatment with the product(Up to 24 months)