An Open-Label Study of Aficamten for Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 12
- 主要终点
- Incidence of adverse events observed during dosing of Aficamten in patients with symptomatic oHCM.
研究概览
简要总结
This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state Pharmacokinetics (PK) during chronic dosing with 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 CK-3773274
- •LVEF ≥55% at the Screening Visit
排除标准
- •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 study of aficamten has:Developed new-onset paroxysmal or permanent atrial fibrillation (AF) requiring rhythm restoring treatment (e.g., direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may rescreen for JX01003 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 appropriate implantable cardioverter defibrillator (ICD) shock within 30 days prior to screening.
- •Has received treatment with mavacamten.
研究组 & 干预措施
Aficamten
Patients in this arm take daily dose of Aficamten. Each patient will start at the lowest dose (5 mg) in the pre-specified dose range and undergo dose titration up to a maximum of 20 mg.
干预措施: Aficamten (Drug)
结局指标
主要结局
Incidence of adverse events observed during dosing of Aficamten in patients with symptomatic oHCM.
时间窗: through study completion, at least 1 year
* Patient incidence of reported adverse events (AEs) * Patient incidence of reported serious adverse events (SAEs) * Patient incidence of left ventricular ejection fraction (LVEF) \< 40 %
次要结局
未报告次要终点