EUCTR2020-003571-17-IT进行中（未招募）1 期
An Open-Label Study of CK3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM) and Left Ventricular Outflow Tract Obstruction - na
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients are eligible to be included in the study only if all the following criteria apply:
- •1. Able to comprehend and willing to sign an ICF and willing to comply with all study procedures and restrictions for the duration specified in the Schedule of Activities.
- •2. Completion of a Cytokinetics trial investigating CK-3773274. If unable to complete due to circumstances not related to compliance or safety, Medical Monitor may review and determine eligibility.
- •3. Left ventricular ejection fraction = 55%.
- •4. Male patients are eligible to participate if they agree to the following during the study and for at least 10 weeks after the last dose of IP:
- •a. Refrain from donating sperm
- •Plus either:
- •b. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- •Must agree to use a male condom and, when his female partner is a woman of childbearing potential, have his female partner use a highly effective method of contraception (as described in Appendix 3 [Section10.3] of the protocol)
- •5. A female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •a. Is not a woman of childbearing potential (WOCBP; as described in Appendix 3 [Section 10.3] of the protocol)
- •Is a WOCBP and using a highly effective method of contraceptive (as described in Appendix 3 [Section 10.3]) during the study and for at least 4 weeks after the last dose of IP.
- •b. A WOCBP must have a negative pregnancy test (urine or serum as required by local regulations) within 3 days before the first dose of study
- •intervention.
- •Note: The Principal Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Contraceptive use by men or WOCBPs should be consistent with the guidance in Appendix 3 (Section 10.3) and local regulations regarding the methods of contraception for those participating in clinical studies.
- •6. Willing and able to complete all screening procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •- Has taken any investigational study drug other than CK-3773274 within 30 days prior to screening.
- •- Since completion of a previous trial of CK-3773274 has:
- •1. Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days.
- •2. Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation).
- •- Has current obstructive coronary artery disease (>70% stenosis
- •documented in one or more arteries).
- •- Has moderate or severe aortic valve stenosis.
- •- Had a confirmed LVEF <40% with an associated dose interruption during CY 6021. If data from the participant's cohort has been unblinded, the patient may be considered for entry into CY 6022 (see Section 6.6.1 of the protocol).
- •- Has been treated with drugs that have negative inotropic activity within 30 days prior to screening.
- •- History of syncope or sustained ventricular tachyarrhythmia with exercise within 30 days prior to screening.
- •- History of appropriate ICD shock within 30 days prior to screening.
- •- Has received treatment with mavacamten within 3 months prior to screening.
- •Exclusion Criteria for CMR sub-study:
- •- Inability to tolerate CMR.
- •- Has an implantable cardioverter-defibrillator (ICD).
- •- Has a cardiac pacemaker.
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