NCT03723655已完成2 期
A Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)
Bristol-Myers Squibb68 个研究点 分布在 7 个国家目标入组 314 人开始时间: 2018年9月27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
- 已完成
- 发起方
- 入组人数
- 314
- 试验地点
- 68
- 主要终点
- Frequency and severity of treatment-emergent adverse events and serious adverse events
研究概览
简要总结
Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study.
Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study.
Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Site, Care Provider and Patients are blinded to study dose. Sponsor is now unblinded to study dose.
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
- •Has completed the Parent Study through to the EOS Visit within 90 days of consent. (Participants who are beyond the 90-day window from EOS Visit may be included in this study pending MyoKardia Medical Monitoring approval) Participants who prematurely discontinued from the Parent Study or the MAVA-LTE study may be considered for inclusion.
- •Has a body weight greater than 45 kg at the Screening Visit
- •Has adequate acoustic windows to enable accurate TTEs.
- •Has documented LVEF ≥ 50% by echocardiography core laboratory read of screening TTE at rest.
- •Has safety laboratory parameters (chemistry, hematology, coagulation, and urinalysis) within normal limits (according to the central laboratory reference range).
- •Female participants must not be pregnant or lactating and, if sexually active, must use one of the following highly effective birth control methods from the Screening Visit through 90 days after the last dose of investigational medicinal product (IMP).
- •In addition to the above contraceptive requirements for female participants, male partners must also use a contraceptive (eg. barrier, condom, or vasectomy).
排除标准
- •Has any ECG abnormality considered by the investigator to pose a risk to participant safety (eg. second degree atrioventricular block type II).
- •Has a history of syncope or a history of sustained ventricular tachyarrhythmia with exercise between Parent Study EOS Visit and Screening Visit.
- •Has a history of resuscitated sudden cardiac arrest or known history of appropriate implantable cardioverter-defibrillator (ICD) discharge for life-threatening ventricular arrhythmia between Parent Study EOS Visit and Screening Visit. (Note: history of anti-tachycardia pacing (ATP) is allowed).• Currently treated with disopyramide or ranolazine (within 14 days prior to Screening) or treatment with disopyramide or ranolazine is planned during the study.
- •Has any acute or serious comorbid condition (eg. major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the judgment of the Investigator, could lead to premature termination of study participation or interfere with the measurement or interpretation of the efficacy and safety assessments in the study.
- •History of clinically significant malignant disease that developed since enrollment in the Parent Study.
- •Is unable to comply with the study requirements, including the number of required visits to the clinical site.
- •Has participated in a clinical trial in which the participant received any investigational drug (or is currently using an investigational device) within 30 days prior to Screening, or at least 5 times the respective elimination half-life (whichever is longer), except for participation in MAVERICK-HCM or EXPLORER-HCM. Prior participation in a non-interventional observational study is allowed.
研究组 & 干预措施
Group 1
Experimental
Active Treatment for participants with base target trough concentration
干预措施: mavacamten (Drug)
Group 2
Experimental
Active Treatment for participants with higher target trough concentration
干预措施: mavacamten (Drug)
Group 3
Experimental
Active Treatment for participants dose titrated to clinical response
干预措施: mavacamten (Drug)
结局指标
主要结局
Frequency and severity of treatment-emergent adverse events and serious adverse events
时间窗: 252 weeks
次要结局
未报告次要终点
研究者
研究点 (68)
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