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    Summary
    EudraCT Number:2015-002105-11
    Sponsor's Protocol Code Number:BTT-gpASIT009
    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:2015-07-24
    Trial 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 number2015-002105-11
    A.3Full title of the trial
    A multicenter, international, randomised, double-blind, placebo controlled study to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis
    Multicentrické, mezinárodní, randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení k prokázání klinické účinnosti a bezpečnosti subkutánní imunoterapie přípravkem gpASIT+™ u pacientů s alergickou rhinokonjunktivitidou vyvolanou pyly trav
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study where patients will receive either a new medication (grass pollen -ASIT+TM of gpASIT+TM) either placebo (an inert substance) to treat patients with grass pollen-induced allergic rhinoconjunctivitis. Both products will administered in a subcutaneous way.
    A.3.2Name or abbreviated title of the trial where available
    not availabe
    A.4.1Sponsor's protocol code numberBTT-gpASIT009
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02560948
    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 SponsorASIT biotech S.A.
    B.1.3.4CountryBelgium
    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 supportASIT biotech S.A.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASIT biotech S.A.
    B.5.2Functional name of contact pointPirotton Sabine
    B.5.3 Address:
    B.5.3.1Street AddressAv. Ariane 5
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number3222640395
    B.5.5Fax number3222640399
    B.5.6E-mailsabine.pirotton@biotech.be
    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.3.1Product namegpASIT+TM
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgpASIT+TM
    D.3.9.3Other descriptive namePOLLEN PEPTIDES
    D.3.9.4EV Substance CodeSUB168148
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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 placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of seasonal grass pollen rhinoconjunctivitis
    E.1.1.1Medical condition in easily understood language
    Treatment of hay fever
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10019170
    E.1.2Term Hay fever
    E.1.2System Organ Class 100000004870
    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 clinical trial is to demonstrate the clinical efficacy of gpASIT+TM during the peak of the grass pollen season following subcutaneous administration to patients suffering from hay fever.
    Primárním cílem tohoto klinického hodnocení je prokázání klinické účinnosti přípravku gpASIT+TM během vrcholné pylové sezóny trav po subkutánním podání pacientům trpícím sennou rýmou
    E.2.2Secondary objectives of the trial
    The secondary objectives are
    • To assess individual symptom and medication scores over the peak and entire pollen season after treatment with gpASIT+TM compared to placebo,
    • To assess changes in allergic reactivity to Conjunctival Provocation Test (CPT) after treatment with gpASIT+TM compared to placebo,
    • To assess the Quality-of-Life of patients and health economic aspects after treatment with gpASIT+TM compared to placebo,
    • To assess the safety and clinical tolerability of gpASIT+TM treatment.
    Sekundární cíle jsou:
    • Vyhodnotit skóre jednotlivých symptomů a medikace na vrcholu pylové sezóny a v celém jejím průběhupo léčbě přípravkem gpASIT+TM ve srovnání s placebem.
    • Vyhodnotit změny alergické reaktivity na spojivkový provokační test (CPT) po léčbě přípravkem gpASIT+TM ve srovnání s placebem.
    • Vyhodnotit kvalitu života pacientů a zdravotně ekonomické aspekty po léčbě přípravkem gpASIT+TM ve srovnání s placebem.
    • Vyhodnotit bezpečnost a klinickou snášenlivost léčby přípravkem gpASIT+TM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed and dated Informed Consent Form by a legally competent patient
    • Female or male patients aged 18–64 years
    • The patients are in good physical and mental health according to his/her medical history and vital signs
    • For Females: non-pregnant, non-lactating females with adequate contraception or females unable to bear children (i.e. tubul ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period))
    • Allergy diagnosis:
    o A medical history of moderate to severe seasonal allergic rhinoconjunctivitis (SARC) for the grass pollen season during at least the two previous seasons (definition of allergy severity according to ARIA (Bousquet et al 2001))
    o A positive skin prick test (SPT - wheal diameter ≥ 3 mm) to grass pollen mixture, histamine wheal ≥ 3 mm, NaCl control reaction < 2 mm
    o Specific IgE against grass pollen (with recombinant allergens - g213) > 0.7 kU/L.
    o Positive response to CPT with at least the grass allergen solution dilution 1/10 in all sites where the CPT solution is available at the start of the study
    • Patients treated with anti-allergic medication for at least 2 grass pollen seasons prior to enrollment
    • For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014)
    • For patients with co-sensitisation to birch and parietaria (except Germany) pollen allergens, all of the following criteria must be fulfilled:
    o The result of the SPT to birch and parietaria (except Germany) pollen has to be less than the result to grass pollen
    o The specific-IgE level to birch and parietaria (except Germany) pollen allergens has to be less than the specific-IgE level to grass (the CAP RAST class for birch and parietaria has to be at least 1 CAP RAST class less than the CAP RAST class for grass)
    • Podepsaný a datovaný formulář informovaného souhlasu právně způsobilým pacientem
    • Pacient nebo pacientka ve věku 18–64 let
    • Pacienti s dobrým fyzickým i duševním zdravotním stavem na základě anamnézy a vitálních funkcí
    • Ženy: nejsou těhotné, nekojí, používají odpovídající antikoncepci nebo nemohou otěhotnět (tubální ligace,
    hysterektomie nebo po menopauze (což je definováno jako minimálně rok od poslední menstruace))
    • Diagnóza alergie:
    o Anamnéza středně závažné až závažné sezónní alergické rhinokonjunktivitidy (SARC) v sezóně pylů trav
    během alespoň dvou předcházejících sezón (definice závažnosti alergie podle iniciativy ARIA (Bousquet et
    al 2001))
    o Pozitivní kožní prick test (SPT - průměr pupence ≥ 3 mm) na směs travních pylů, histaminový pupenec ≥ 3
    mm, reakce na kontrolní roztok NaCl < 2 mm
    o Specifický IgE proti travním pylům (pomocí rekombinantních alergenů - g213) > 0,7 kU/l.
    o Pozitivní odezva na CPT při alespoň 10 000 SQ-E/ml travních alergenů
    • Pacienti léčení antialergickou medikací nejméně po dobu 2 pylových sezón trav před zařazením
    • Pacienti s astmatem: potvrzená diagnóza astmatu pod kontrolou podle směrnic Globální iniciativy pro
    astma (GINA) (kroky 1-3, GINA 2014)
    • U pacientů se současnou senzibilizací na alergeny pylů břízy a parietaria (drnavec) musejí být splněna
    všechna následující kritéria:
    o Výsledek testu SPT na pyly břízy a parietaria musí být nižší než výsledek na pyly trav.
    o Hladina specifického IgE na alergeny z pylu břízy a parietaria musí být nižší než hladina specifického IgE na
    trávu (třída CAP RAST pro břízu a parietaria musí být alespoň o 1 třídu CAP RAST menší než třída CAP RAST
    pro trávy).
    E.4Principal exclusion criteria
    • Patients with a history of hypersensitivity to the excipients of the investigational product (gpASIT+TM or placebo)
    • Patients with partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014).
    • Patients with chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) < 80% of the predicted value (ECSC) or with a peak expiratory flow (PEF) < 70% of the individual optimum value
    • Patients symptomatic to inhaled allergens circulating during the grass pollen season (specific to each country: e.g. birch, hazel, mugwort, ragweed, olive, Alternaria alternata)
    • Patients symptomatic to perennial inhaled allergens (house dust mites, cat, dog) to which the patients are regularly exposed
    • Patients with a history of significant renal disease or chronic hepatic disease
    • Patients with malignant disease
    • Patients with a known severe autoimmune disease
    • Patients with any chronic disease which may impair the patient’s ability to participate in the trial (e.g. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.)
    • Patients requiring beta-blockers/acetylcholinesterase inhibitors medication
    • Patients requiring antidepressant drugs with potent antihistamine properties i.e. tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.)
    • Patients requiring anti-IgE antibodies, mast cell stabilizers, anti-leukotriene agents or interleukin treatment (e.g. anti-IL 5)
    • Patients with any contraindication for the use of adrenaline
    • Patients with a known positive serology for Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
    • Patients who are immunocompromised by medication or illness, have received a vaccine, corticoids or immunosuppressive medications within 1 month before study entry
    • Female patients who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method
    • Consumption of corticosteroids (oral, topic or nasal) or of anti-histaminic drugs within time period preceding the trial (screening visit), as defined in Chapter VIII.6 of the protocol
    • Patients with laboratory values greater than grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit *
    • Unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a severe psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol

    *Patients with laboratory values greater than grade 1 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit will require a retest and only if normalising, the patient will be eligible.
    • Souběžná účast v jiných klinických hodnoceních nebo předchozí účast do 30 dnů před zařazením
    • Předchozí imunoterapie travními alergeny během posledních 5 let
    • Probíhající imunoterapie travními alergeny nebo jinými alergeny
    • Pacienti v jakémkoliv vztahu k zadavateli, smluvní výzkumné organizaci a/nebo zkoušejícímu nebo na nich
    závislí
    • Neschopnost pochopit pokyny / dokumenty klinického hodnocení
    • Pacienti s anamnézou anafylaxe, zahrnující potraviny (např. arašídy nebo mořské plody) nebo jed
    blanokřídlého hmyzu (např. bodnutí včely nebo vosy) nebo léky (např. penicilin)
    • Pacienti s anamnézou hypersenzitivity na pomocné látky hodnoceného přípravku (gpASIT+TM nebo placebo)
    • Pacienti s astmatem pod částečnou kontrolou nebo pod nedostatečnou kontrolou podle směrnic GINA (GINA
    2014).
    • Pacienti s chronickým astmatem nebo s emfyzémem, zejména s usilovným výdechovým objemem za 1
    sekundu (FEV1) < 80 % normální hodnoty (ECSC) nebo s nejvyšší výdechovou rychlostí (PEF) < 70 %
    individuální optimální hodnoty
    • Pacienti symptomatičtí na inhalační alergeny vyskytující se během pylové sezóny trav (specifické pro každou
    zemi: např. bříza, líska, pelyněk, ambrózie, oliva, houba Alternaria alternata)
    • Pacienti symptomatičtí na celoroční inhalační alergeny (roztoči bytového prachu, kočky, psi), kterým jsou tito
    pacienti pravidelně vystavováni
    • Pacienti s anamnézou závažného onemocnění ledvin nebo chronického onemocnění jater
    • Pacienti se zhoubným onemocněním
    • Pacienti se známým těžkým autoimunitním onemocněním
    • Pacienti s jakýmkoliv chronickým onemocněním, které může zhoršit jejich schopnost účastnit se klinického
    hodnocení (např. závažné městnavé srdeční selhání, aktivní žaludeční vřed, zánětlivé střevní onemocnění,
    nekompenzovaný diabetes mellitus atd.)
    • Pacienti vyžadující medikaci beta blokátory nebo inhibitory acetylcholinesterázy
    • Pacienti vyžadující léčbu antidepresivy se silnými antihistaminovými vlastnostmi, tedy tricyklickými
    antidepresivy (např. doxepin, amitriptylin, desipramin, imipramin atd.)
    • Pacienti vyžadující léčbu anti-IgE protilátkami, stabilizátory žírných buněk nebo anti-leukotrieny
    • Pacienti s jakoukoliv kontraindikací k použití adrenalinu
    • Pacienti se známou pozitivní sérologií na virus lidské imunodeficience-1/2, virus hepatitidy B nebo virus
    hepatitidy C
    • Pacienti, kteří mají oslabenou imunitu kvůli lékům nebo nemoci, kteří užívali vakcinační, kortikoidní nebo
    imunosupresivní léky v období 1 měsíce před vstupem do studie.
    • Pacientky, které jsou těhotné, kojí nebo mohou otěhotnět a nejsou chráněné před těhotenstvím dostatečně
    spolehlivou metodou
    • Užívání kortikosteroidů (orálně, topicky nebo nazálně) nebo antihistaminik v období předcházejícím
    klinickému hodnocení (skríninková návštěva), podle definice v kapitole VIII.6 protokolu
    • Pacienti s laboratorními hodnotami při skríninkové návštěvě většími než stupeň 2 podle Pokynů FDA pro
    Odvětví preventivních vakcinačních klinických hodnocení (FDA 2007) *
    • Nespolehliví pacienti včetně těch, co nedodržují pokyny, pacienti se známým alkoholismem nebo se
    zneužíváním léků nebo s anamnézou závažné psychiatrické poruchy, a také pacienti, kteří nejsou ochotni
    podepsat informovaný souhlas nebo plnit požadavky protokolu

    *Pacienty s laboratorními hodnotami při skríninkové návštěvě většími než stupeň 1 podle Pokynů FDA pro Odvětví preventivních vakcinačních klinických hodnocení (FDA 2007) bude nutné znovu otestovat a budou způsobilí, jedině když budou výsledky normální.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the reduction - in the treated group compared to the placebo group - of the Combined Symptom and Medication Score (CSMS) taking into account the daily Rhinoconjunctivitis Total Symptom Score (RTSS) and the daily Rescue Medication Score (RMS) over the peak of grass pollen season subsequent to treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    reduction of the Combined Symptom and Medication Score (CSMS): during the peak of the grass pollen season.
    E.5.2Secondary end point(s)
    • Clinical efficacy endpoints will include:
    - Combined Symptom and Medication Score (CSMS) over the entire grass pollen season
    - Rhinoconjunctivitis Total Symptom Score (RTSS) over the peak period and the pollen season
    - Rescue Medication Score (RMS) over the peak period and the pollen season
    - Symptom sub-scores (Eyes, Nose) over the peak period and the pollen season
    - Well days over the peak period and the pollen season
    - In monosensitised patients
    - CSMS over the peak period and the pollen season
    - RTSS over the peak period and the pollen season
    - RMS over the peak period and the pollen season
    - In asthmatic patients
    - CSMS over the peak period and the pollen season
    - RTSS over the peak period and the pollen season
    - RMS over the peak period and the pollen season
    - Lung symptoms over the peak period and the pollen season
    - Total Symptom Score (TSS; the sum of the nose, eye and lung scores) over the peak period and the pollen
    season
    - Use of rescue medication to relief asthma symptoms over the peak period and the pollen season
    - I the subgroup of patients receiving 10-12 injections of gpASIT+TM
    - CSMS over the peak period
    • Conjunctival Provocation Test (CPT) outcomes in sites concerned (see Chapter VII.7.3)
    • Quality-of-Life Questionnaires:
    - Standardised Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ(S)) and Nocturnal Rhinoconjunctivitis
    Quality-of-Life Questionnaire (NRQLQ) in all patients
    - Standardised Asthma Quality-of-Life Questionnaire (AQLQ(S)) in asthmatic patients
    • Health economic endpoints:
    - Number of working days lost due to grass pollen-induced allergy symptoms
    - Loss of productivity at work due to grass pollen induced-allergy symptoms, using a visual analog scale (VAS)
    • Responder analysis on
    - Reactivity to CPT: one patient will be considered as a responder if the reactivity to CPT decreases between
    V1 and V6
    - CSMS over the peak pollen period and entire pollen season: one patient will be considered as a responder if
    the score is lower of at least 20% with respect to the median score observed in the placebo group
    • Safety and clinical tolerability endpoints will include:
    - Solicited adverse events:
    - Local reactions at the injection site (swelling and redness) after investigational product administration
     - Allergic systemic reactions after investigational product administration
    - Unsolicited adverse events and serious adverse events
    - Physical examinations and vital signs
    - Laboratory investigations (haematology, clinical biochemistry, immunological parameters)
    - Use of rescue mediction during treatment phase
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Clinical efficacy endpoints: during the peak and entire pollen season
    • Conjunctival Provocation Test (CPT) outcomes: at visit 1 and 6
    • Quality-of-Life Questionnaires: at visit 6, 7 and 8
    • Health economic endpoints: at visit 6, 7 and 8
    • Responder analysis on
    - Reactivity to CPT: at visit 6
    - CSMS: during peak and entire season
    • Safety and clinical tolerability endpoints
    - Solicited adverse events: visit 2, 3, 4 and 5
    - Unsolicited adverse events and serious adverse events: visit 2 to visit 8
    - Physical examinations and vital signs: visit 1 to visit 8
    - Laboratory investigations (haematology, clinical biochemistry, immunological parameters): visit 1, 6 and 8
    - Use of rescue mediction during treatment phase: visit 2, 3, 4 and 5
    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 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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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: 654
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state162
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 654
    F.4.2.2In the whole clinical trial 654
    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 Decision2015-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-15
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