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    Summary
    EudraCT Number:2016-002146-23
    Sponsor's Protocol Code Number:ASN100-201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-20
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-002146-23
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Single Dose of ASN100 for the Prevention of Staphylococcus aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects
    Studio randomizzato di fase 2, in doppio cieco, controllato verso placebo, volto a determinare la sicurezza e l¿efficacia di una dose singola di ASN100 per la prevenzione della polmonite da Staphylococcus aureus in soggetti ventilati meccanicamente, fortemente colonizzati
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of ASN100 in Ventilated Subjects
    Studio su ASN100 in soggetti ventilati
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberASN100-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02940626
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorARSANIS 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 supportArsanis, INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Czech Republic s.r.o
    B.5.2Functional name of contact pointRegulatory Submissions
    B.5.3 Address:
    B.5.3.1Street AddressPrague Office Park II, K Hajum 2606/2b
    B.5.3.2Town/ cityPrague
    B.5.3.3Post code15000
    B.5.3.4CountryCzechia
    B.5.4Telephone number4202515514664169
    B.5.5Fax number420251510801
    B.5.6E-mailregsubmissions@medpace.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.3.1Product nameASN-1
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnon ancora assegnato
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameASN-1
    D.3.9.4EV Substance CodeSUB178400
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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.3.1Product nameASN-2
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameASN-2
    D.3.9.4EV Substance CodeSUB178401
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of Staphylococcus aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects
    Prevenzione della polmonite da Staphylococcus aureus in soggetti ventilati meccanicamente, fortemente colonizzati
    E.1.1.1Medical condition in easily understood language
    Pneumonia in Mechanically Ventilated Subjects
    Polmonite in soggetti ventilati meccanicamente
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10035664
    E.1.2Term Pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ¿To evaluate the safety, tolerability, and efficacy of a single dose of ASN100 (administered as ASN-1 and ASN-2 components) versus placebo for the prevention of S. aureus pneumonia in mechanically ventilated subjects who are heavily colonized with S. aureus.
    valutare sicurezza, tollerabilit¿ ed efficacia di una dose singola di ASN100 (somministrato come componenti ASN-1 e ASN-2) rispetto a placebo per la prevenzione della polmonite da S. aureus in soggetti ventilati meccanicamente, fortemente colonizzati con S. aureus.
    E.2.2Secondary objectives of the trial
    ¿To compare the duration of mechanical ventilation post-treatment in subjects treated with ASN100 versus placebo;
    ¿To compare the length of stay in the intensive care unit (ICU) post-treatment for subjects treated with ASN100 versus placebo;
    ¿To determine the serum pharmacokinetics (PK) (i.e., maximum serum concentration [Cmax], time to maximum serum concentration [Tmax], area under the serum concentration-time curve [AUC], and terminal elimination half-life [t1/2]) of ASN-1 and ASN-2 in mechanically ventilated subjects heavily colonized with S. aureus; and
    ¿To compare 28-day all-cause mortality in subjects treated with ASN100 versus placebo.
    ¿ confrontare la durata della ventilazione meccanica post-trattamento in soggetti trattati con ASN100 rispetto a placebo;
    ¿ confrontare la durata della degenza post-trattamento nell¿Unit¿ di terapia intensiva (UTI) dei soggetti trattati con ASN100 rispetto a placebo;
    ¿ determinare la farmacocinetica (PK) sierica (ovvero, la concentrazione sierica massima [Cmax], il tempo alla concentrazione sierica massima [Tmax], l¿area sotto la curva [AUC] concentrazione sierica-tempo) e l¿emivita di eliminazione terminale [t1/2]) di ASN-1 e ASN-2 in soggetti ventilati meccanicamente, fortemente colonizzati con S. aureus; e
    ¿ confrontare la mortalit¿ da tutte le cause a 28 giorni in soggetti trattati con ASN100 rispetto a placebo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Bronchoalveolar lavage (BAL) fluid pharmacokinetic sub-study
    Approximately 25 to 35 subjects will participate in this sub-study and will have BAL fluid collected 48 hours (¿36 hours) post-dose (on Day 2 or Day 3, depending on time of study drug administration) to determine ASN-1 and ASN-2 levels and and calculate a blood to epithelial lining fluid (ELF) ratio.
    The version date and number are the same as the ASN100-201 study

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio di farmacocinetica su fluido di lavaggio broncoalveolare (BAL). A cira 25-35 pazienti che parteciperanno al sottostudio verr¿ prelevato 48 ore (+-36 ore) dopo la somministrazione (nel Giorno 2 o nel Giorno 3, in base alla tempistica di somministrazione del farmaco dello studio) per determinare i livelli di ASN-1 e ASN-2 e calcolare il rapporto "blood to epithelial lining
    fluid (ELF)".
    E.3Principal inclusion criteria
    1.Subject or legally authorized representative or council of independent physicians (CIP) (if applicable) has provided written informed consent;
    2.Subject is 18 years of age or older at the time of enrollment;
    3.Subject is currently hospitalized and is mechanically ventilated endotracheally (i.e. orotracheal or nasotracheal);
    NOTE: Subjects with a tracheostomy at the time of enrollment are not elegible. After enrollment, conversion to tracheostomy is permitted per standard of care.
    4.Female subjects must not be pregnant or lactating. Female subjects of childbearing potential must have a documented negative pregnancy test at the Screening visit. Female subjects may be enrolled on the basis of a negative urine pregnancy test, pending the result of a negative serum pregnancy test prior to randomization; and
    5.Female subjects of childbearing potential and non-surgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post dose. Approved forms of contraception include hormonal contraceptives, intrauterine device, or partner sterility.
    NOTE: The following categories define women who are NOT considered to be of childbearing potential:
    •Premenopausal female with 1 of the following:
    o Documented hysterectomy,
    o Documented bilateral salpingectomy, or
    o Documented bilateral oophorectomy, or
    •Postmenopausal female, defined as having amenorrhea for at least 12 months without an alternative medical cause.
    1. il soggetto o il rappresentante legale o il consiglio dei medici indipendenti (se applicabile) ha fornito consenso informato scritto;
    2. il soggetto ha un’età ¿ 18 anni al momento dell’arruolamento;
    3. il soggetto è attualmente ricoverato e sottoposto a ventilazione meccanica con intubazione endotracheale (ossia orotracheale o nasotracheale) e, a giudizio dello sperimentatore, richiederà un supporto ventilatorio continuo per almeno 48 ore;
    NOTA: I soggetti con tracheostomia al momento dell'arruolamento non sono considerati idonei. Dopo l'arruolamento, la tracheostomizzazione è permessa secondo lo standard locale.
    4. i soggetti di sesso femminile non devono essere in stato di gravidanza o allattamento. I soggetti di sesso femminile in età fertile devono disporre di un test di gravidanza negativo documentato alla visita di Screening. I soggetti di sesso femminile possono essere arruolati sulla base dell’esito negativo di un test di gravidanza urinario, in attesa del risultato negativo di un test di gravidanza sul siero prima della randomizzazione; e
    5. se sessualmente attivi, i soggetti di sesso femminile in età fertile e i soggetti di sesso maschile non chirurgicamente sterili devono acconsentire a utilizzare una forma di contraccezione altamente efficace e approvata dalla firma del consenso informato fino a 165 giorni dopo la somministrazione della dose. Le forme di contraccezione approvate comprendono dispositivi intrauterini (IUD) ormonali, contraccettivi ormonali (pillola anticoncezionale orale, formulazioni a rilascio prolungato, cerotto o preparazioni iniettabili) insieme a metodi a doppia barriera aggiuntivi, quali preservativi o diaframmi con gel o schiuma spermicida.
    NOTA: Le seguenti categorie definiscono le donne che NON sono considerate in età fertile:
    • Donne in premenopausa con 1 delle seguenti:
    o isterectomia documentata,
    o salpingectomia bilaterale documentata, o
    o ovariectomia bilaterale documentata, oppure
    • Donne in postmenopausa, definite come soggetti con amenorrea da almeno 12 mesi senza una causa medica alternativa.
    E.4Principal exclusion criteria
    1.Subject has received intravenous (IV) immunoglobulin therapy within 4 months prior to the Screening visit;
    2. Subject has a chest X-Ray or thoracic CT scan that is definitive for a diagnosis of pneumonia
    3.Subject demonstrates both of the following:
    a.Need for acute changes in ventilator support to enhance oxygenation or to the amount of positive end-expiratory pressure; and
    NOTE: Changes made in ventilator support due to day to day maintenance other than those changes made to improve oxygenation will not exclude a subject from participation in the study.
    b.New onset of purulent suctioned respiratory secretions;
    4.Subject has known and documented ETA culture showing heavy colonization with a Gram-negative organism at enrollment or at any time during the Screening period;
    NOTE: Randomization should not be delayed while waiting for Gram-negative results if heavy colonization with S. aureus has been confirmed.
    5.Subject has been diagnosed with neutropenia (absolute neutrophil count 500/mm3);
    6.Subject has a severe non-pulmonary source of infection which, in the Investigator’s opinion, would interfere with the conduct of the study or jeopardize the subject’s safety;
    7.Subject is currently on either continuous veno- venous hemodialysis or extracorporeal membrane oxygenation;
    8.Subject has been previously exposed to ASN100 or ASN-1 or ASN-2, individually;
    9.Subject has a known hypersensitivity to ASN100 or any of its excipients;
    10.Subject has received any investigational product within 30 days prior to the Screening Visit (or 5 half-lives of the investigational product, whichever is longer);
    11.Subject has, in the opinion of the Investigator, a high probability of death within 72 hours of enrollment;
    12.Subject is, in the opinion of the Investigator, not able or willing to comply with the protocol; or
    13.Any condition that, in the opinion of the Investigator, would compromise the safety of the subject, the potential activity of the study drug, or the quality of the data; or
    14. Subject has a known history or current (suspected) diagnosis of cytokine release syndrome associated with the administration of peptides, proteins, and/or antibodies.
    NOTE: Subjects with a prior history of sepsis are not excluded.
    1. il soggetto ha ricevuto una terapia immunoglobulinica endovenosa (EV) nei 4 mesi precedenti la visita di Screening;
    2. il soggetto presenta una radiografia del torace o una tomografia computerizzata (TC) del torace che dimostra la presenza di polmonite;
    3. il soggetto presenta entrambe le seguenti:
    a. necessità di modifiche acute al supporto ventilatorio per aumentare l’ossigenazione o alla quantità di pressione positiva di fine espirazione; e
    NOTA: Le modifiche al supporto ventilatorio legate alla manutenzione quotidiana, diverse da quelle effettuate per migliorare l’ossigenazione, non comporteranno l’esclusione di un soggetto dalla partecipazione allo studio
    b. nuova insorgenza di secrezioni respiratorie aspirate di tipo purulento;
    4. il soggetto presenta una forte colonizzazione (documentata da ETA) o un’infezione note da organismo Gram-negativo all'arruolamento o in qualsiasi altro momento durante il period di screening;
    NOTA: la randomizzazione non va ritardata in attesa dei risultati per i Gram-negativi se è stata confermata la presenza di una forte colonizzazione da S. aureus
    5. il soggetto ha ricevuto una diagnosi di neutropenia (conta assoluta dei neutrofili ¿ 500/mm3);
    6. il soggetto presenta una grave fonte non polmonare di infezione che, a giudizio dello sperimentatore, potrebbe interferire con la conduzione dello studio o compromettere la sicurezza del soggetto;
    7. il soggetto è attualmente in terapia con emodialisi veno-venosa continua od ossigenazione a membrana extra-corporea;
    8. il soggetto è stato precedentemente esposto ad ASN100 oppure ad ASN-1 o ASN-2 separatamente;
    9. il soggetto presenta un’ipersensibilità nota ad ASN100 o a uno qualsiasi dei suoi eccipienti;
    10. il soggetto ha ricevuto qualsiasi prodotto sperimentale nei 30 giorni precedenti la Visita di Screening (o entro 5 emivite del prodotto sperimentale, a seconda di quale sia il periodo più lungo);
    11. a giudizio dello sperimentatore, il soggetto presenta un’elevata probabilità di decesso entro 72 ore dall'arruolamento;
    12. a giudizio dello sperimentatore, il soggetto non è in grado di attenersi al protocollo o non è disponibile a farlo;
    13. qualsiasi condizione che, a giudizio dello sperimentatore, potrebbe compromettere potrebbe compromettere la sicurezza del soggetto, l'attività del farmaco sperimentale o la qualità dei dati;
    14. soggetti con diagnosi pregressa o sospetta (attuale) di sindrome da rilascio di citochine associate alla somministrazione di peptide, protein e/o anticorpi.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects in the MITT Population who develop S. aureus pneumonia as defined in the protocol Section 7.4 up to but not including Day 22.
    Proporzione di soggetti nella Popolazione MITT che sviluppano una polmonite da S. aureus fino al
    Giorno 22 escluso.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endotracheal aspirates will be collected for culture during the screening period to determine the degree of S. aureus. Additional respiratory specimens may be collected throughout the monitoring period if
    clinically indicated. Subjects will be assessed daily throughout the monitoring period for clinical signs and symptoms of pneumonia.
    Gli aspirati endotracheali verranno raccolti per la cultura durante il period di screening per determinare il grado di S. aureus. Altri
    campioni potranno essere raccolti per tutto il periodo di monitoraggio, se clinicamente indicato. I soggetti saranno valutati quotidianamente in tutto il
    periodo di monitoraggio per i segni e sintomi clinici di polmonite.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints include:
    ¿ Duration of mechanical ventilation during the first 21 days postrandomization
    for subjects in the MITT, Intent-to-Treat (ITT), and Per Protocol (PP) Populations;
    ¿Length of ICU stay during the first 21 days post-randomization for subjects
    in the MITT, ITT, and PP Populations;
    ¿The Cmax, Tmax, AUC, and t1/2 of ASN-1 and ASN-2 in serum following
    a single dose of ASN100 in the PK Population; and
    ¿28-day all-cause mortality in the MITT, ITT, and PP Populations.
    ¿ la durata della ventilazione meccanica durante i primi 21 giorni post-randomizzazione per i
    soggetti nelle Popolazioni MITT, ITT e PP;
    ¿ la durata della degenza in UTI durante i primi 21 giorni post-randomizzazione per i soggetti nelle Popolazioni MITT, ITT e PP;
    ¿ i valori di Cmax, Tmax, AUC e t1/2 di ASN-1 e ASN-2 nel siero dopo una dose singola di ASN100 all¿interno della Popolazione PK;
    e
    ¿ la mortalit¿ da tutte le cause a 28 giorni nella Popolazione MITT, ITT e PP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Microbiological and clinical assessments will be done throughout the monitoring period.
    Valutazioni microbiologiche e cliniche saranno effettuati durante il period di monitoraggio.
    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 Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Georgia
    Israel
    Russian Federation
    United States
    Austria
    Czechia
    France
    Germany
    Hungary
    Italy
    Poland
    Portugal
    Spain
    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
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 254
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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
    Subjects maybe ventilated and not fully conscious
    Il paziente probabilmente ventilato potrebbe non essere pienamente consapevole
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state102
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 275
    F.4.2.2In the whole clinical trial 354
    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)
    Patient will return to standard of care
    I pazienti al termine verranno trattati con lo standard di cura
    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 Decision2017-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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