EUCTR2020-003571-17-HU进行中（未招募）1 期
An Open-Label Study of CK-3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM).
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- 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 study 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 [Section 10.3] of the protocol)
- •5. A female patient is eligible to participate if she is not pregnant, breastfeeding or planning to donate eggs, 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]) and male partner agrees to use a condom 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) before the first dose of study IP.
- •Note: The Principal Investigator or designee 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 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •Patients will be excluded from the study if any of the following criteria apply:
- •1. Has received treatment with mavacamten.
- •2. Has participated in another investigational device or drug study or received an investigational device or drug <1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.
- •3. Has any acute or serious comorbid condition (e.g., major infection or hematologic, oncologic, cardiac, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the opinion of the site Principal Investigator/designee or Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion
- •4. Has developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (e.g., direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) within 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if rate (HR <100 bpm) and/or rhythm is stable >30 days. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for =14 days.)
- •5. Has undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation) since the completion of a prior study of CK-3773274.
- •6. Has current obstructive coronary artery disease (>70% stenosis documented in one or more arteries).
- •7. Has moderate or severe aortic valve stenosis
- •8. Had a confirmed LVEF <40% with an associated dose interruption during CY 6021 or CY 6031. If data from the participant’s cohort has been unblinded, the patient may be considered for entry into CY 6022
- •9. History of syncope or sustained ventricular tachyarrhythmia with exercise within 30 days prior to screening
- •10. History of ICD placement within 30 days prior to screening.
- •11. Hypersensitivity to excipients in CK-3773274 Tablets, Film-Coated
- •Criteria for CMR sub-study
- •1. Does not consent to participate in CMR sub-study
- •2. Inability to tolerate CMR
- •3. Has an implantable cardioverter-defibrillator (ICD).
- •4. Has a cardiac pacemaker.
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