A Phase 2, Double-Blind, Randomized, Placebo Controlled, Dose Ranging, Parallel Group Study to Evaluate the Effect of GS-6615 on Ventricular Arrhythmia in Subjects with Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) - GS-US-356-0101

Gilead Sciences0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Gilead Sciences
入组人数: 25

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

年龄范围: 18 至 99（—）

入选标准

•1) Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
•2) Between 18 and 80 years of age (inclusive)
•3) Implanted ICD or CRT-D for primary or secondary prevention
•a) ICD or CRT-D must have capabilities of counting device interventions and storing electrograms
•b) Subjects with ICD or CRT-D implanted for primary prevention must have at least one ICD intervention for VT/VF (shock or ATP) within 60 days prior to Screening
•c) Subjects with ICD or CRT-D implanted for secondary prevention must have at least one ICD intervention for VT/VF (shock or ATP) or a documented VT/VF episode (prior to implantation) within 60 days prior to Screening
•4) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use the protocol specified method(s) of contraception
•5) Subjects must be hemodynamically stable at both Screening and Randomization visits.

排除标准

•1) New York Heart Association (NYHA) Class IV heart failure
•2) Myocardial infarction, unstable angina, coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within 4 weeks prior to Screening or during the screening period before Randomization
•3) Hemodynamically significant primary obstructive valvular disease
•4) History of congenital heart disease
•5) Inherited arrhythmia such as Brugada syndrome. Subjects with LQT-3 or HCM may be considered.
•6) Subjects who are being considered for cardiac transplantation and are on a cardiac transplant list. Subjects who are not expected to have a transplant during the study can be considered for the study after consultation with the Gilead Medical Monitor.
•7) Known or suspected history of seizures or epilepsy
•8) Cardiac ablation within 3 months prior to Screening or planned cardiac ablation during the course of the study
•9) Severe renal impairment at Screening (defined as an estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease [MDRD] equation by the central laboratory)
•10) Abnormal liver function test defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2xULN at Screening, or bilirubin > 1.5xULN at Screening
•11) Current use of Class I and Class III antiarrhythmic drugs; such medications should be discontinued > 5 half-lives (or > 28 days for chronic use of amiodarone) prior to Randomization.
•12) Current use of concomitant treatment with drugs or products that are strong inhibitors or inducers of CYP3A; such medications should be discontinued at least 5 half lives prior to Randomization.
•13) Current use of concomitant treatment with ranolazine. Ranolazine should be discontinued at least 7 days prior to Randomization.
•14) Previous exposure to GS-6615
•15) Known hypersensitivity to the study drug, its metabolites, or formulation excipient
•16) Females who are pregnant or are breastfeeding. Lactating females must agree to discontinue nursing before the study drug is administered. A negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization are required for female subjects of childbearing potential.
•17) Subjects with a subcutaneous ICD
•18) Any ICD/CRT-D -related technical issue, malfunction, or potential malfunction which in the judgment of the investigator would disrupt adequate data collection or interpretation
•19) In the judgment of the investigator, any clinically-significant ongoing medical condition that might jeopardize the subject*s safety or interfere with the study, including participation in another investigational drug or investigational device study within the previous 30 days with potential residual effects that might confound the results of this study
•20) Any condition that in the opinion of the investigator would preclude compliance with the study protocol
•21) Body mass index (BMI) * 36 kg/m2

研究者

发起方

Gilead Sciences

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