An Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)

Bristol-Myers Squibb4 个研究点分布在 1 个国家目标入组 13 人开始时间: 2018年4月26日最近更新: 2025年1月9日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 13
试验地点: 4
主要终点: Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).

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

•Completed Study MYK-461-
•Prior participation in a non-interventional observational study is allowed.
•Body weight > 45 kg at Screening
•Has safety laboratory parameters (chemistry and hematology) within normal limits

排除标准

•Has QTcF > > 500 ms or any other ECG abnormality considered by the investigator to pose a risk to subject safety (eg, second degree atrioventricular block type II)
•Since enrollment into Study MYK-461-004, has developed obstructive coronary artery disease (> 70% stenosis in one or more arteries) or known moderate or severe aortic valve stenosis
•Since enrollment into Study MYK-461-004, has developed any acute or serious comorbid condition (eg, major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the opinion of the investigator or medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
•Since enrollment into Study MYK-461-004 has developed clinically significant malignant disease

研究组 & 干预措施

mavacamten (MYK-461)

Experimental

干预措施: mavacamten (Drug)

结局指标

主要结局

Number of Participants With Treatment Emergent Adverse Events and Treatment Emergent Serious Adverse Events

时间窗: From first dose to end of treatment + 56 days (Approximately an average of 240 Weeks)

AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: * Results in death * Is immediately life-threatening (places the participant at immediate risk of death from the event as it occurred) * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions * Results in a congenital abnormality or birth defect * Is an important medical event that may not result in death, be life- threatening, or require hospitalization, but may be considered an SAE when, based upon appropriate medical judgment, it may require medical or surgical intervention to prevent any of the outcomes listed above.

Number of Participants Who Had Cardiovascular Death