NCT07133815尚未招募2 期
A Multicenter, Single Arm, Open Label Phase II Clinical Study Evaluating the Long-term Efficacy and Safety of SHR-1918 in Homozygous Familial Hypercholesterolemia Patients
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The incidence and severity of adverse events
研究概览
简要总结
A multicenter, single arm, open label phase II clinical study evaluating the long-term efficacy and safety of SHR-1918 in homozygous familial hypercholesterolemia patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Subjects who received and completed the SHR-1918-301 study treatment in previous studies and were deemed to have therapeutic benefits by the researchers
排除标准
- •Known to be allergic to the investigational drug or any component of the investigational drug, or to have experienced severe allergic reactions to other antibody drugs;
- •History of malignant tumors in the past 5 years;
- •There are serious concurrent diseases
- •Pregnant or lactating women;
- •The researchers determined that the subjects had poor compliance or any inappropriate factors for participating in this trial
研究组 & 干预措施
SHR-1918
Experimental
干预措施: SHR-1918 (Drug)
结局指标
主要结局
The incidence and severity of adverse events
时间窗: during the study period About 48 months，
次要结局
未报告次要终点
研究者
研究点 (1)
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