NCT07004972进行中（未招募）4 期
A Phase 4, Single-Arm, Open-Label Study to Evaluate Safety, Tolerability, and Efficacy of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy in India
Bristol-Myers Squibb46 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月4日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 46
- 主要终点
- Incidence of serious Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and effectiveness of mavacamten in adults with obstructive hypertrophic cardiomyopathy in India.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with obstructive hypertrophic cardiomyopathy (HCM) consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines.
- •Has unexplained LV hypertrophy with nondilated ventricular chambers in the absence of other cardiac (ie, hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy).
- •Has LVOT (Valsalva left ventricular outflow tract) peak gradient ≥ 50 mmHg during screening as assessed by TTE at rest or with Valsalva maneuver.
- •Has LVOT peak gradient with Valsalva maneuver at screening TTE of ≥ 30 mmHg.
- •Has adequate acoustic windows to enable accurate TTEs.
- •Has New York Heart Association (NYHA) Class II or III symptoms at screening.
- •Body weight is greater than 45 kg at screening.
- •Documentation of LVEF ≥ 55% at rest of screening TTE.
排除标准
- •Known infiltrative or storage disorder causing cardiac hypertrophy that mimics obstructive hypertrophic cardiomyopathy, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.
- •Has paroxysmal atrial fibrillation present per the investigator's evaluation of the participant's ECG at the time of screening.
- •Has persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to screening and/or not adequately rate controlled within 6 months prior to screening. (Note: Participants with persistent or permanent atrial fibrillation who are anticoagulated and adequately rate-controlled are allowed).
- •Has a history of syncope with exercise within 6 months prior to screening.
- •History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening.
- •Has documented obstructive coronary artery disease (> 70% stenosis in one or more epicardial coronary arteries) or history of myocardial infarction.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Mavacamten
Experimental
干预措施: Mavacamten (Drug)
结局指标
主要结局
Incidence of serious Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to Week 48
次要结局
- Number of participants with heart failure (HF) events(Up to Week 48)
- Number of participants with atrial fibrillation/flutter(Up to Weeks 48)
- Number of participants with syncope(Up to Week 48)
- Number of participants with left ventricular ejection fraction (LVEF) < 50%(Up to Week 30)
- Number of participants with major adverse cardiac events(Up to Week 48)
- Number of participants with CV hospitalization(Up to Week 48)
- Number of participants with left ventricular ejection fraction (LVEF) < 45%(Up to Week 30)
- Number of participants with left ventricular ejection fraction (LVEF) < 40%(Up to Week 30)
- Number of participants with left ventricular ejection fraction (LVEF) < 30%(Up to Week 30)
- Number of participants with non-serious AEs(Up to Week 48)
- Change from baseline to Week 30 in Valsalva left ventricular outflow tract (LVOT) peak gradient(Up to Week 30)
- Change from baseline to Week 30 in resting LVOT peak gradient(Up to Week 30)
- Change from baseline to Week 30 in hs-troponin-I(Up to Week 30)
- Change from baseline to Week 30 in N-terminal pro b-type natriuretic peptide (NT-proBNP)(Up to Week 30)
- Proportion of participants with at least 1 class improvement in New York Heart Association (NYHA) functional class from baseline to Week 30(Up to Week 30)
研究者
研究点 (46)
Loading locations...
相似试验
已完成
4 期
A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)Juvenile Idiopathic ArthritisNCT03301883Hoffmann-La Roche62
已完成
4 期
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric PatientsPathological ProcessesNCT01092754Guerbet100
已完成
4 期
A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck RegionPsoriasisNCT05789576Organon and Co31
已完成
1 期
Open Label Phase 1 Study in Japan for Patient With Advanced Solid MalignanciesAdvanced Solid MalignancyAdvanced Solid TumorNCT01353781AstraZeneca39
已完成
4 期
A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque PsoriasisPsoriasisNCT05680740Organon and Co34