NCT07021963招募中2 期
A Multicenter, Open-label Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年7月4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
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs).
研究概览
简要总结
This study mainly evaluates the long-term safety of HRS-1893 in subjects with hypertrophic cardiomyopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with hypertrophic cardiomyopathy who have previously completed HRS-1893 related studies.
- •Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must be non-lactating during the study. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time they sign the informed consent form until 3 months after the last dose of trial drug, and to comply with relevant contraceptive requirements.
- •Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
排除标准
- •Previous history of coronary artery disease (stenosis of one or more coronary arteries >70%) or myocardial infarction.
- •Have received medication for negative inotropic other than disopyramide, β-blocker, verapamil, diltiazem 4 weeks before screening.
- •History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
- •Other conditions that the investigator considers the subject to be unsuitable for participating in this trial, such as physical or psychological diseases or conditions that may increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial.
研究组 & 干预措施
Obstructive Hypertrophic Cardiomyopathy Group
Experimental
干预措施: HRS-1893 Tablet (Drug)
Non-obstructive Hypertrophic Cardiomyopathy Group
Experimental
干预措施: HRS-1893 Tablet (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs).
时间窗: About 1 year.
Incidence of left ventricular ejection fraction (LVEF) <50%.
时间窗: About 1 year.
次要结局
- The change in cardiac troponin from baseline.(Week 24 and Week 52.)
- The change in N-terminal B-type natriuretic peptide (NT-proBNP) from baseline.(Week 24 and Week 52.)
研究者
研究点 (1)
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