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    Summary
    EudraCT Number:2013-004430-15
    Sponsor's Protocol Code Number:GS-US-356-0101
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2013-004430-15
    A.3Full title of the trial
    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)
    Randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení fáze 2 s paralelními skupinami, hodnotící účinnost léčby s různými dávkami přípravku GS-6615 na komorovou arytmii u pacientů s implantabilním kardioverter-defibrilátorem (ICD) nebo s defibrilátorem pro srdeční resynchronizační terapii (CRT D)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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)
    A.4.1Sponsor's protocol code numberGS-US-356-0101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02104583
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences, Inc.
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address333 Lakeside Drive
    B.5.3.2Town/ cityFoster City
    B.5.3.3Post codeCA 944 04
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16505743000
    B.5.5Fax number+16505789264
    B.5.6E-mailclinical.trials@gilead.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code GS-6615 3 mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNo INN or proposed INN available
    D.3.9.1CAS number 1443211-72-0
    D.3.9.2Current sponsor codeGS-6615
    D.3.9.3Other descriptive nameCAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
    D.3.9.4EV Substance CodeSUB130565
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code GS-6615 10 mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNo INN or proposed INN available
    D.3.9.1CAS number 1443211-72-0
    D.3.9.2Current sponsor codeGS-6615
    D.3.9.3Other descriptive nameCAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] and IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
    D.3.9.4EV Substance CodeSUB130565
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with an ICD or CRT-D implanted for primary or secondary prevention
    E.1.1.1Medical condition in easily understood language
    Subjects with Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT D)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10047281
    E.1.2Term Ventricular arrhythmia
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the effect of GS-6615 compared to placebo on the overall occurrence of appropriate ICD interventions (antitachycardia pacing [ATP] or shock) in subjects with ICD or CRT-D during the first 24 weeks of treatment
    E.2.2Secondary objectives of the trial
    The overall occurrence of appropriate ICD interventions in subjects with ICD or CRT-D through the end of the study
    Premature ventricular complex count/48 hours after 12 weeks of treatment
    Nonsustained ventricular tachycardia episodes/48 hours after 12 weeks of treatment
    The overall occurrence of ventricular tachycardia/ventricular fibrillation, (treated and untreated) during the first 24 weeks and through the end of the study
    The time from randomization to the first occurrence of appropriate ICD interventions (ATP or shock) or cardiovascular (CV) death
    The overall occurrence of electrical storm during the first 24 weeks and through the end of the study
    The occurrence of inappropriate ICD interventions during the first 24 weeks and through the end of the study
    Time from randomization to the first CV hospitalization, CV emergency room (ER) visit, or CV death
    Left ventricular (LV) systolic and diastolic function as assessed by echocardiography (ECHO)
    Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the overall occurrence (total number) of appropriate ICD interventions (ATP or shock) through Week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monitoring will be conducted on subject in the clinic at Randomization (Day 1 of the Treatment period), Week 2, Week 4, Week 12, Week 24, and every 12 weeks thereafter until the last subject randomized is followed up for approximately 24 weeks
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    - Overall occurrence (total number) of appropriate ICD interventions (ATP or shock) through the end of the study
    - The change in PVC (count/48 hours) from Screening to Week 12
    - The change in nsVT (number of episodes/48 hours) from Screening to Week 12
    - Overall occurrence (total number) of VT/VF (treated or untreated) through Week 24 and through the end of the study
    - The time from randomization to the first occurrence of appropriate ICD interventions (ATP or shock) or CV death
    - Overall occurrence (total number) of electrical storm through Week 24 and through the end of the study
    - Overall occurrence (total number) of inappropriate ICD interventions through Week 24 and through the end of the study
    - Time from randomization to the first occurrence of CV hospitalization, CV ER visit, or CV death
    - Change in LV systolic and diastolic function as assessed by ECHO at Week 12 and Week 24
    Safety will be assessed by collecting AEs, vital signs, clinical laboratory tests, PE findings, and ECG data (PR, RR, QRS, and QT interval)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monitoring will be conducted on subject in the clinic at Randomization (Day 1 of the Treatment period), Week 4, Week 12, Week 24, and every 12 weeks thereafter until the end of the study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Czech Republic
    Denmark
    Germany
    Hungary
    Israel
    Netherlands
    Poland
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 270
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After a patient has completed/terminated their study participation, long term care for the participant will remain the responsability of their primary treating physicians.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-14
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