A FOLLOW-UP, OPEN-LABEL, RESEARCH EVALUATION OF SUSTAINED TREATMENT WITH AFICAMTEN (CK-3773274) IN HYPERTROPHIC CARDIOMYOPATHY (HCM)

Cytokinetics, Inc.0 个研究点目标入组 600 人开始时间: 2022年11月25日最近更新: 2024年7月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Cytokinetics, Inc.
入组人数: 600

研究概览入排标准研究者记录与标识符相似试验

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 (LVEF) = 55%.
•4. Male patients are eligible to participate if they agree to the following:
•a. Refrain from donating sperm during the trial plus at least 10 weeks after the last dose of IP
•b. During the trial plus 4 weeks after the last dose of IP either:
•- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent in writing
•Must agree to use a male condom when his female partner is a woman of childbearing potential, and 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 420
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 180

排除标准

•Patients will be excluded from the study if any of the following criteria apply:
•1. Has received treatment with mavacamten:
•(a) within 56 days prior to dosing and
•(b) has not received approval for participation from the Medical Monitor.
•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. Since completion of a previous study of CK-3773274, 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 (heart rate <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. Since completion of a previous study of CK-3773274, has undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation) since the completion of a prior study of CK-3773274.
•6. Had a confirmed LVEF <40% with an associated dose interruption during participation in a prior study with CK-3773274. If data from the patient's cohort has been unblinded, the patient may be considered for entry into CY 6022 after the patient’s unblinded data have been reviewed by Cytokinetics and discussion between the Principal Investigator (or designee) and Medical Monitor.
•7. History of implantable cardioverter-defibrillator (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 ICD.
•4. Has a cardiac pacemaker.

研究者

发起方

Cytokinetics, Inc.

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