NCT04848506Enrolling By Invitation2 期
A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)
Cytokinetics225 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2021年5月6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
- Enrolling By Invitation
- 发起方
- 入组人数
- 900
- 试验地点
- 225
- 主要终点
- Incidence of adverse events observed during dosing of aficamten in patients with HCM
研究概览
简要总结
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of a Cytokinetics trial investigating aficamten
- •LVEF ≥ 55% at the Screening Visit
排除标准
- •Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
- •Has participated in another investigational device or drug study or received an investigational device or drug < 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.
- •Since completion of a previous trial of aficamten has:
- •Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) < 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) < 100 bpm and/or rhythm is stable > 30 days
- •Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation)
- •Had a confirmed LVEF < 40% with an associated dose interruption during participation in a prior study with aficamten
- •History of implantable ICD placement within 30 days prior to screening.
研究组 & 干预措施
Aficamten up to 20 mg
Experimental
Patients in this arm take daily dose of aficamten. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose.
干预措施: Aficamten (5 - 20 mg) (Drug)
结局指标
主要结局
Incidence of adverse events observed during dosing of aficamten in patients with HCM
时间窗: Baseline to End of study, up to 5 years
Patient incidence of reported Adverse Events (AEs)
次要结局
- Incidence of serious adverse events observed during dosing of aficamten in patients with HCM(Baseline to End of study, up to 5 years)
- Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of aficamten in patients with HCM(Baseline to End of study, up to 5 years)
- Long-term effects of aficamten on left ventricular outflow tract gradient (LVOT G) in patients with oHCM(Baseline through the end of participation at 12-24 week intervals)
- Long-term effects of aficamten on resting LVOT-G(Baseline through the end of participation at 12-24 week intervals)
- Long-term effects of aficamten on left ventricular ejection fraction (LVEF) and post-Valsalva LVOT-G(Baseline through the end of participation at 12-24 week intervals)
- Long-term effects of aficamten on time to first resting LVOT-G < 30 mmHg through last follow-up(Time to the following event through last follow-up, up to 5 years)
- Long-term effects of aficamten on time to first post-Valsalva LVOT-G < 50 mmHg through last follow-up(Time to the following event through last follow-up, up to 5 years)
- Long-term effects of aficamten on time to first post-Valsalva LVOT-G < 30 mmHg through last follow-up(Time to the following event through last follow-up, up to 5 years)
- Long-term effects of aficamten on time to first LVEF ≥ 50%, resting LVOT-G < 30 mmHg, and post-Valsalva LVOT-G < 50 mmHg through last follow-up(Time to the following event through last follow-up, up to 5 years)
- Long-term effects of aficamten on post Valsalva LVOT-G(Baseline through the end of participation at 12-24 week intervals)
研究者
研究点 (225)
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