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    Summary
    EudraCT Number:2015-002283-16
    Sponsor's Protocol Code Number:1P50HL112349
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-16
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-002283-16
    A.3Full title of the trial
    Phase II randomized, placebo-controlled, double blind clinical trial of valsartan for attenuating disease evolution in early sarcomeric HCM
    En randomiseret, placebo-kontrolleret, dobbel-blindet undersøgelse af effekten af valsartan på sygdomsprogression ved tidlig hypertrofisk kardiomyopati
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international study of the effect of Valsartan in hypertrophic cardiomyopathy.
    ET INTERNATIONALT STUDIE VEDRØRENDE EFFEKTEN AF VALSARTAN TIL PATIENTER MED HYPERTROFISK KARDIOMYOPATI
    A.3.2Name or abbreviated title of the trial where available
    VANISH
    A.4.1Sponsor's protocol code number1P50HL112349
    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 SponsorNational Heart, Lung, and Blood Institute / National Institutes of Health
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHeart Development and Structural Diseases Branch / Division of Cardiovascular Sciences National Heart, Lung, and Blood I
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHeart Development and Structural Diseases Branch / Division of Cardiovascular Sciences National Heart, Lung, and Blood I
    B.5.2Functional name of contact pointKristin Burns
    B.5.3 Address:
    B.5.3.1Street Address6701 Rockledge Drive
    B.5.3.2Town/ cityBethesda
    B.5.3.3Post codeMD 20892
    B.5.3.4CountryUnited States
    B.5.4Telephone number001301-594-6859
    B.5.5Fax number001301-480-2858
    B.5.6E-mailkristin.burns@nih.gov
    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 Yes
    D.2.1.1.1Trade name Diovan 40 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form 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 INNVALSARTAN
    D.3.9.1CAS number 137862-53-4
    D.3.9.2Current sponsor codeDiovan
    D.3.9.3Other descriptive nameDiovan
    D.3.9.4EV Substance CodeSUB00017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.2.1.1.1Trade name Diovan 80 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form 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 INNVALSARTAN
    D.3.9.1CAS number 137862-53-4
    D.3.9.2Current sponsor codeDiovan
    D.3.9.3Other descriptive nameDiovan
    D.3.9.4EV Substance CodeSUB00017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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: 3
    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 Yes
    D.2.1.1.1Trade name Diovan 160 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form 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 INNVALSARTAN
    D.3.9.1CAS number 137862-53-4
    D.3.9.4EV Substance CodeSUB00017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 placeboCoated 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 placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated 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
    Hypertrophic cardiomyopathy
    Hypertrofisk kardiomyopati
    E.1.1.1Medical condition in easily understood language
    Hypertrophic cardiomyopathy
    Hypertrofisk kardiomyopati
    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 LLT
    E.1.2Classification code 10020204
    E.1.2Term HOCM Hypertrophic obstructive cardiomyopathy
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of Valsartan in young patients in an early stage of hypertrophic cardiomyopathy.
    At undersøge effekten af Valsartan hos unge patienter i et tidlig stadium af hypertrofisk kardiomyopati.
    E.2.2Secondary objectives of the trial
    To assess the safety of Valsartan in young patients in an early stage of hypertrophic cardiomyopathy.
    At undersøge om Valsartan er sikkert hos unge patienter i et tidlig stadium af hypertrofisk kardiomyopati.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    5.2 Inclusion Criteria
    1. All subjects must have a Pathogenic or Likely Pathogenic HCM Sarcomere Mutation
    a. The following categories of mutations are considered acceptable for subjects who have previously undergone clinical genetic testing. If results are ambiguous or testing was performed at a lab other than those listed below, they will be reviewed by the Clinical Coordinating Center to determine eligibility.
    i. Laboratory for Molecular Medicine
    1. Pathogenic
    2. Likely Pathogenic
    ii. Transgenomics/ PGXHealth
    1. Class I
    iii. GeneDx
    1. Disease causing
    2. Variant, likely disease-causing
    3. Published, disease-causing mutation
    4. Novel, likely disease-causing, mutation
    iv. Correlagen
    1. Associated
    2. Probably Associated
    2. Group 1 Cohort
    a. LV wall thickness ≥12 mm and ≤25 mm or z score ≥3 and ≤18 as determined by rapid assessment by the echocardiographic core laboratory
    b. NYHA functional class I or II; no perceived or only slight limitations in physical activities
    c. No resting or provokable LV obstruction (peak gradient ≤ 30 mmHg) on clinically-obtained ETT-echo within the past 24 months or transthoracic echo with Valsalva maneuver within the past 12 months
    d. Age 8-45 years
    3. Group 2 Cohort (G+/LVH-)
    a. LV Wall Thickness <12 mm and z score <3, as determined by rapid assessment by the echocardiographic core laboratory
    b. Age 10-25 years
    c. E’ z score ≤ -1.5 OR ECG abnormalities other than NSSTW changes (Q waves, T wave inversion, repolarization changes) OR LV wall thickness z-score 1.5-2.9 combined with LV thickness to dimension ratio ≥0.19 (as determined by rapid assessment by the echocardiographic core laboratory)

    4. Able to attend follow-up appointments, complete all study assessments, and provide written informed consent
    Inklusionskriterier
    Alle forsøgspersoner skal have en genfejl der er blevet klassificeret som sygdomsfremkallende eller formentlig sygdomsfremkallende for HCM.
    1) Gruppe 1
    a) Maksimal tykkelse af hjertets væg ≥12 mm og ≤25 mm eller z score ≥3 og ≤18 bedømt af Core lab ud fra ekkokardiografi.
    b) NYHA klasse I eller II; ingen eller kun få begrænsninger ved fysisk aktivitet.
    c) Ingen udløbsgradient (modstand mod at blodet løber forbi hjertemuskelfortykkelsen og ud i hovedpulsåren). Ekkokardiografisk målt gradient skal foreligge og have været ≤ 30 mmHg under stress (indenfor sidste 24 måneder) eller under Valsalva manøvre (indenfor 12 måneder).
    d) Alder 8-45 år.
    2) Gruppe 2
    a) Maksimal tykkelse af hjertets væg <12 mm og z score <3 bedømt af Core lab ud fra ekkokardiografi.
    b) Alder 10-25 år.
    c) E’ z score ≤ -1.5 eller abnormt EKG (andet end non-specifikke ST-ændringer; f.eks. Q-takker, T-taks inversion eller repolariserings abnormaliteter).
    3) Kunne medvirke til opfølgende besøg, alle undersøgelser samt give samtykke.
    E.4Principal exclusion criteria
    5.3 Subject Exclusion Criteria
    1. Contraindication to ARB administration, including impaired renal function, hyperkalemia (serum K>5.0 mmol/L), prior history of angioedema
    2. Medical conditions associated with increased collagen turnover that may confound interpretation of biomarkers of collagen synthesis (liver, pulmonary or renal fibrosis, inflammatory states, cancer, trauma or surgery within 6 months of enrollment)
    3. Concomitant use of Spironolactone, Lithium, Aliskren, ARB or ACE-inhibitors.. If these drugs are in active use but not necessary for medical care, they may be discontinued and baseline studies can be performed after a 2-week washout period.
    4. Pregnant or breastfeeding females
    5. Females of childbearing potential with no effective contraceptive method (including abstinence)
    6. Uncontrolled systemic HTN [persistent SBP>160 and/or DBP>90 in adult or equivalent in children (e.g. SBP>99th or DBP>95th percentile for sex, age, and height centile based on the American Academy of Pediatrics normal values)
    7. Obstructive physiology, defined by resting, Valsalva-provoked or exercise-induced gradient >30mmHg within the past 24 months
    8. Prior septal myectomy or alcohol septal ablation
    9. Known, suspected, or symptomatic coronary artery disease or evidence of prior myocardial infarction based on symptoms or cardiac imaging
    10. More than mild valvular heart disease or clinically significant congenital heart disease. Allowable conditions include bicuspid aortic valve without clinically significant stenosis or regurgitation; spontaneously closed ventricular septal defects; patent foramen ovale, small (≤ 2 mm) restrictive ventricular septal defects with normal ventricular size, and other minor defects that are considered allowable after [review and consensus by participating pediatric cardiologists, overall study PI and] adjudication by the echocardiographic core laboratory.
    11. LVEF <55%
    12. Concomitant medical conditions that would preclude performance of or confound interpretation of echocardiography, exercise testing, or CMR (e.g., renal insufficiency, lung disease, orthopedic/rheumatologic conditions, atrial fibrillation)
    13. Secondary prevention implantable cardioverter-defibrillator device (ICD; primary prevention ICDs without a history of appropriate therapy, including shock or ATP, are allowable).
    14. Prior treatment or hospitalization for symptomatic heart failure
    15. Participation in a clinical trial (except observational studies) involving investigational medications within the previous 30 days.
    Eksklusionskriterier
    1) Kontraindikation til valsartan inklusive hyperkaliæmi, nedsat nyrefunktion, tidligere angioødem.
    2) Sygdomme der er associeret med en øget kollagen omsætning og som kan lede til forvirring ved fortolkning af de biomarkører der er involverede i kollagen syntese (lever, lunge eller nyre fibrose, inflammatoriske sygdomme, cancer, trauma eller operation indenfor de seneste 6 måneder)
    3) Behandling indenfor de seneste 2 uger med en medicin der hæmmer renin-angiotensin-systemet
    4) Graviditet eller amning
    5) Intet brug af sikker prævention (se neden for detalier*)
    6) Systolisk blodtryk >160 eller diastolisk blodtryk> 90 hos voksne eller tilsvarende hos børn (Systolisk blodtryk >99th or diastolisk blodtryk>95th percentilen for køn, alder og højde baseret på the American Academy of Pediatrics normalværdier).
    7) Udløbsgradient >30 mmHg i hvile, under Valsalva manøvre eller ved stress ekkokardiografi indenfor 24 måneder.
    8) Tidligere myektomi eller alkohol ablation
    9) Kendt eller mistænkt, tidligere eller nuværende sygdom i kranspulsårerne.
    10) Mere end mild hjerteklapssygdom eller medfødt hjertesygdom udfra detaljerede kriterier i protokollen.
    11) Nedsat pumpefunktion af hjertet (LVEF <55%)
    12) Komorbiditet som kan medføre nedsat arbejdskapacitet eller som kan forstyrre fortolkningen af undersøgelserne (f.eks. nyresvigt, lungesygdom, sygdomme i bevægeapparatet, atrieflimmer).
    13) Sekundær profylaktisk ICD (Primær prævention ICD uden tidligere shock eller ATP er tilladt).
    14) Tidligere behandling eller indlæggelse pga. symptomgivende hjertesvigt.
    15) Deltagelse indenfor de sidste 30 dage i et klinisk studie der involverer afprøvning af medicin.
    E.5 End points
    E.5.1Primary end point(s)
    We hypothesize that administration of the ARB, valsartan, compared to placebo, will demonstrate treatment efficacy across multiple domains of cardiac structure/ function and clinical outcomes. Average z scores will be calculated for key components of the primary outcome. The primary endpoint will compare the composite total z score across all domains for sarcomere mutation carriers with at least borderline left ventricular hypertrophy (designated Group 1) treated with valsartan compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year and 2 years
    E.5.2Secondary end point(s)
    We will more broadly characterize the impact of valsartan treatment on disease pathology, and identify variables that may influence both treatment response and disease progression. We will assess the impact of valsartan therapy on the important but relatively rare cohort of preclinical HCM (designated Group 2). These analyses will provide a crucial foundation for future studies to test novel strategies of disease prevention.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year and 2 years
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 No
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    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 years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 75
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For children under the age of 18 consent will be given by the parents/legal guardians.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 150
    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)
    None
    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 Decision2016-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-01
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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