A clinical trial with GS-6615 for treatment of Ventricular Arrhythmia in Subjects with Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D)

Phase 1

• Conditions: Subjects with an ICD or CRT-D implanted for primary or secondary prevention; MedDRA version: 17.0Level: PTClassification code 10047281Term: Ventricular arrhythmiaSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-004430-15-DK
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-11
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

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 as described in Appendix 3
5) Subjects must be hemodynamically stable at both Screening and Randomization visits as defined by: systolic blood pressure = 90 mmHg, HR = 100 beats/min, and not requiring mechanical circulatory support (intra-aortic balloon pump or LV assist device), or treatment with IV inotropic drugs, IV vasodilators, or IV diuretics.
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified