NL-OMON54979已完成3 期
A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICKHCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Has completed the Parent Study through to the EOS Visit within
- •90 days of signing consent. (Participants who are beyond the 90
- •day window from EOS Visit may be included in this study
- •pending MyoKardia Medical Monitor approval). Participants who prematurely
- •discontinued
- •from the Parent Study or the MAVA LTE study may be considered for
- •2. Is able to understand and comply with the study procedures,
- •understand the risks involved in the study, and provide informed
- •consent according to federal, local, and institutional guidelines
- •before the first study-specific procedure
- •3. Body weight is greater than 45 kg at the Screening Visit or Day 1
- •(Day 1 weight must be verified prior to dosing)
- •4. Has adequate acoustic windows to enable accurate TTEs (refer to
- •Echocardiography Site Instruction Manual)
- •5. Has documented LVEF >= 50% by echocardiography core
- •laboratory read of screening TTE at rest
- •6. Has safety laboratory parameters within normal limits (according
- •to the central laboratory reference range); however, a participant
- •with safety laboratory parameters outside normal limits may be
- •included if he or she meets all of the following criteria:
- •The safety laboratory parameter outside normal limits is
- •considered by the Investigator to be clinically unimportant
- •If there is an alanine aminotransferase or aspartate
- •aminotransferase result, the value must be < 3× the upper limit
- •of the laboratory reference range
- •The body size-adjusted estimated glomerular filtration rate is
- •>= 30 mL/min/1.73 m2
- •7. 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).
- •combined (estrogen- and progestogen-containing) hormonal
- •contraception associated with inhibition of ovulation or
- •progestogen-only hormonal contraception associated with inhibition of ovulation
- •by oral, implantable, or injectable route
- •of administration
- •intrauterine device (IUD)
- •intrauterine hormone-releasing system (IUS)
- •bilateral tubal occlusion
- •Female is surgically sterile for 6 months or postmenopausal
- •for 1 year. Permanent sterilization includes hysterectomy,
- •bilateral oophorectomy, bilateral salpingectomy, and/or
- •documented bilateral tubal occlusion at least 6 months prior to
- •Screening. Females are considered postmenopausal if they
- •have had amenorrhea for at least 1 year or more following
- •cessation of all exogenous hormonal treatments and follicle
- •stimulating hormone (FSH) levels are in the postmenopausal
- •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
- •1. Has persistent or permanent atrial fibrillation not on
- •anticoagulation for at least 4 weeks prior and/or is not adequately
- •rate-controlled
- •(Note: participants with persistent or permanent atrial fibrillation
- •who are anticoagulated and adequately rate-controlled are
- •2. Is currently taking, or has taken within 14 days of Screening, a
- •prohibited medication such as a cytochrome P450 (CYP) 2C19
- •inhibitor (eg, omeprazole), a strong CYP 3A4 inhibitor, or St.
- •John*s Wort (see APPENDIX 2 for more details)
- •3. Has QTcF > 500 ms at Screening or any other ECG abnormality
- •considered by the Investigator to pose a risk to participant safety
- •(eg, second degree atrioventricular block type II)
- •4. Has documented obstructive coronary artery disease (> 70%
- •stenosis in one or more epicardial coronary arteries) or history of
- •myocardial infarction
- •5. Has known moderate or severe (as per Investigator*s judgment)
- •aortic valve stenosis at Screening Visit
- •6. Has hypersensitivity to any of the components of the mavacamten
- •formulation
- •7. 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 noninterventional
- •observational study is
- •8. Has a history of syncope or a history of sustained ventricular
- •tachyarrhythmia with exercise between Parent Study EOS Visit and
- •9. 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
- •(Note: history of anti-tachycardia pacing (ATP) is
- •10. Currently treated with disopyramide or ranolazine (within 14 days
- •prior to Screening Visit) or treatment with disopyramide or ranolazine is
- •planned during the
- •11. Currently treated or planned treatment during the study with a
- •combination of beta blocker and verapamil or a combination of beta
- •blocker and
- •12. 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
- •13. History of clinically significant malignant disease that developed
- •since enrollment in the Parent
- •Participants who have been successfully treated for nonmetastatic
- •cutaneous squamous cell or basal cell carcinoma or have been
- •adequately treated for cervical carcinoma in situ or breast ductal
- •carcinoma in situ (DCIS) can be included in the
- •14. Is unable to comply with the study requirements, including the
- 另有 3 项未显示
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