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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41018   clinical trials with a EudraCT protocol, of which   6709   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2017-003356-23
    Sponsor's Protocol Code Number:ALX0171-C204
    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:2018-11-13
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-003356-23
    A.3Full title of the trial
    A randomized, double-blind, multicenter study to evaluate the efficacy and safety of ALX-0171 versus placebo, in addition to standard of care, in adults who have undergone hematopoietic stem cell transplantation and present with a respiratory syncytial virus respiratory tract infection
    Studio randomizzato, in doppio cieco, multicentrico, volto a valutare l’efficacia e la sicurezza di ALX-0171 rispetto a placebo, in aggiunta alla terapia standard, in adulti sottoposti a trapianto di cellule staminali ematopoietiche e che presentano un’infezione delle vie respiratorie causata da virus respiratorio sinciziale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of ALX-0171 in adults hematopoietic stem cell transplant (HST) recipients who present with an respiratory syncytial virus (RSV) infection
    Efficacia e sicurezza di ALX-0171 in pazienti adulti trapiantati con cellule staminali ematopoietiche (HST) che presentano con un'infezione da virus respiratorio sinciziale (RSV)
    A.3.2Name or abbreviated title of the trial where available
    Safety and antiviral effect of ALX-0171 in adult HSCT recipients who present with RSV infection
    Sicurezza e effetto antivirale di ALX-0171 in pazienti adulti sottoposti a trapianto di midollo osse
    A.4.1Sponsor's protocol code numberALX0171-C204
    A.5.4Other Identifiers
    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 SponsorABLYNX NV
    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 supportAblynx NV
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAblynx NV
    B.5.2Functional name of contact pointClinical Trial Team
    B.5.3 Address:
    B.5.3.1Street AddressTechnologiepark
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post code9052
    B.5.4Telephone number003292620000
    B.5.5Fax number003292620001
    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 nameALX-0171
    D.3.2Product code ALX-0171
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeALX-0171
    D.3.9.3Other descriptive nameALX-0171
    D.3.9.4EV Substance CodeSUB117525
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboNebuliser solution
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory Syncytial Virus Infection
    Infezione da Virus Respiratorio Sinciziale
    E.1.1.1Medical condition in easily understood language
    RSV infection
    Infezione RSV
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    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
    The primary objective of the trial is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with RSV respiratory tract infection after HSCT
    L'obiettivo principale della sperimentazione è valutare l'effetto antivirale e la sicurezza dell'ALX-0171 inalato in adulti con diagnosi di infezione del tratto respiratorio da RSV dopo trapianto di cellule staminali ematopoietiche
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial are: assess the clinical activity, PK, virology and immunogenecity of inhaled ALX-0171 in adults diagnosed with RSV respiratory tract infection after HSCT
    Gli obiettivi secondari dello studio sono: valutare l'attività clinica, PK, virologia e immunogenicità di ALX-0171 inalato in adulti con diagnosi di infezione del tratto respiratorio da RSV dopo trapianto di cellule staminali ematopoietiche
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is male or female, inpatient/outpatient, agend 18-75 years at screening
    2. Subject has received an HSCT using any conditioning regiment and for any underlying etiology (an autologous HSCT within 90 days of screening or an allogeneic HSCT within 180 days of screening or an allogeneic HSCT within 365 days of screening with ongoing chronic GVHD requiring systemic immunosuppresive therapy or subjects who have undergone transplantation with T-cell-depleted graft)
    3. Clinically diagnosed with RSV infection with new onset or acute worsening (in case of pre-existing symptoms due to underlying respiratory disease) of at least one of the following symptoms: rhinorrhea/nasal congestion, sore throat, cough or dyspnea
    4. Symptoms likely related to RSV infection have appeared within 5 days of screening and their severity requires initial or maintained hospitalization as judged by the investigator
    5. Documented RSV infection in the upper respiratory tract (ie mid-turbinate nasal swam, nasopharyngeal swab, nasopharyngeal aspirate, nasal wash), as determined by local testing. Samples collected within 5 days of screening will be acceptable. If not yet available the assessments should be performed at the time of screening.
    6. Subject has: a) diagnosis of RSV LRT disease OR b) diagnosis of RSV URT disease with high risk of progression to LRTI
    7. Female subjects of childbearing potential (ie fertile, following menarche and until becoming post-menopausal unless permanently sterile) and fertile male subjects must agree to use highly effective contraceptive methods prior to study entry, for the duration of the study participation and for 3 months after the last dose of the study drug.
    8. Female subjects of childbearing potential (exclusing postmenopausal women, sterilized, ovariectomized and hysterectomized women) must have a negative pregnancy test assessed locally at screening
    9. Subject is capable to comprehend the informed consent document and provides a signed and dated Informed Consent Form
    10. Subject must be willing and able (according to the investigator) to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    1. Soggetto di sesso maschile o femminile, in regime ospedaliero/ambulatoriale, di età 18-75 anni allo screening.
    2. Il soggetto ha ricevuto un HSCT utilizzando un qualsiasi regime di condizionamento e per qualsiasi eziologia sottostante: un HSCT autologo entro 90 giorni dallo screening, oppure un HSCT allogenico entro 180 giorni dallo screening, oppure un HSCT allogenico entro 365 giorni dallo screening per i soggetti con malattia del trapianto contro l’ospite (Graft-Versus-Host Disease, GVHD) cronica e in fase attiva che richiede una terapia immunosoppressiva sistemica o soggetti che si sono sottoposti a trapianto con innesto T-depleto.
    3. Il soggetto presenta una diagnosi clinica di infezione da RSV con nuovo episodio di o peggioramento acuto (in caso di sintomi preesistenti dovuti alla malattia respiratoria sottostante) di almeno uno dei seguenti sintomi: rinorrea/congestione nasale, mal di gola, tosse o dispnea.
    4. I sintomi probabilmente correlati all’infezione da RSV sono comparsi entro 5 giorni dallo screening e la loro gravità richiede un ricovero iniziale o il proseguimento di quello in corso, secondo il parere dello sperimentatore.
    5. Infezione documentata da RSV delle vie respiratorie superiori (Upper Respiratory Tract, URT) (es. tampone nasale del turbinato medio, tampone nasofaringeo, aspirato nasofaringeo, lavaggio nasale), come stabilito da analisi locale. Saranno accettabili campioni raccolti entro 5 giorni dallo screening. Se non ancora disponibili, le valutazioni devono essere eseguite al momento dello screening.
    6. Il soggetto presenta diagnosi di malattia da RSV delle vie respiratorie inferiori (Lower Respiratory Tract, LRT) oppure diagnosi di malattia delle URT da RSV con alto rischio di progressione in LRTI.
    7. I soggetti di sesso femminile in età fertile (ovvero, fertili, dopo menarca e fino alla fase post-menopausale, salvo se permanentemente sterili) e i soggetti fertili di sesso maschile devono acconsentire all’uso di metodi contraccettivi altamente efficaci prima di accedere allo studio, per la durata della partecipazione allo studio e nei 3 mesi successivi all’ultima dose del farmaco in studio.
    8. I soggetti di sesso femminile in età fertile (escluse le donne in post-menopausa, sterilizzate e le donne sottoposte a ovariectomia e isterectomia) devono risultare negative al test di gravidanza valutato a livello locale allo screening.
    9. Il soggetto è in grado di comprendere il documento di consenso informato e fornisce un Modulo di consenso informato (Informed Consent Form, ICF) firmato e datato.
    10. Il soggetto deve essere disposto a e in grado di (secondo lo sperimentatore) attenersi alle visite programmate, al piano terapeutico, agli esami di laboratorio e alle altre procedure dello studio (es. raccolta di campioni nasali ed ematici, procedura di inalazione del farmaco in studio).
    E.4Principal exclusion criteria
    1. Subject has clinically significant bacteremia or fungemia within 7 days of screening for which adequate treatment has not been completed at screening as determined by the investigator
    2. Subject has clinically significant bacterial, fungal or viral pneumonia (other than the current RSV episode) within 15 days of screening that has not been adequately treated, as determined by the investigator
    3. Subject is known to be HIV positive
    4. Subject presents evidence of shock requiring ICU monitoring and/or vasopressor treatment
    5. Subject requires or is expected to require invasive mechanical ventilation or intensive non-invasive respiratory support (CPAP, BiPAP, HFOT). Standard oxygen supplementation up to 6l/minute is permitted provided it can be interrupted for the duration of the study drug administration
    6. Subject has been/is being treated with any of the following
    - any investigational antiviral medication or investigational biological within 5 half lives of screening
    - any investigational inhaled treatment within 5 half lives of screening
    - any monoclonal anti-RSV antibodies within 4 months or 5 half lives of screening (whichever is longer)
    - any investigational vaccine after HSCT
    - Aerosolized ribavirin within 3 days of screening or needing to initiate or continue this treatment
    7. Subject is pregnant or breastfeeding
    8. Subject has history of drug or alcohol abuse within 5 years of screening
    9. Subject has concurrent life-threatening disease with life expectancy of less than 1 month
    10. Subject has significant underlying lung disease that confounds the assessment of the RSV episode or any condition that, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of any study endpoints
    11. Subject was previously enrolled in a clinical study of ALX-0171 (including the current study ALX0171-C204)
    12. Subject has a known hypersensitivity to the study drug or any excipient of the study drug
    Il soggetto presenta batteriemia o fungemia clinicamente significativa entro 7 giorni dallo screening per la quale il trattamento adeguato non sia stato completato allo screening, come stabilito dallo sperimentatore.
    2. Il soggetto presenta polmonite batterica, fungina o virale clinicamente significativa (diversa dall’attuale episodio di infezione da RSV) entro 15 giorni dallo screening che non sia stata adeguatamente trattata, come stabilito dallo sperimentatore.
    3. Il soggetto è notoriamente positivo al virus dell’immunodeficienza umana (Human Immunodeficiency Virus, HIV).
    4. Il soggetto presenta segni di shock che richiedono un monitoraggio nell’unità di terapia intensiva (UTI) e/o trattamento con vasopressori.
    5. Il soggetto necessita o si prevede che necessiti di ventilazione meccanica invasiva o supporto respiratorio intensivo non invasivo (ovvero, pressione positiva continua delle vie aeree [Continuous Positive Airway Pressure, CPAP], pressione positiva bilivello delle vie aeree [Bilevel Positive Airway Pressure, BiPAP] o ossigeno terapia ad alto flusso [High Flow Oxygen Therapy, HFOT]). È consentita la somministrazione di ossigeno supplementare standard fino a 6 l/min, a condizione che possa essere interrotta per la durata della somministrazione del farmaco in studio.
    6. Il soggetto è stato/viene sottoposto a uno qualsiasi dei seguenti trattamenti:
    - Qualsiasi farmaco antivirale sperimentale o farmaco biologico sperimentale entro 5 emivite dallo screening
    - Qualsiasi trattamento inalatorio sperimentale entro 5 emivite dallo screening
    - Qualsiasi anticorpo monoclonale anti-RSV entro 4 mesi o 5 emivite dallo screening (a seconda di quale condizione duri di più)
    - Qualsiasi vaccino sperimentale dopo HSCT
    - Ribavirina via aerosol entro 3 giorni dallo screening o necessità di iniziare o proseguire tale trattamento
    7. Il soggetto è in gravidanza o allattamento al seno.
    8. Il soggetto presenta un’anamnesi di abuso di droghe e/o alcol entro 5 anni dallo screening.
    9. Il soggetto presenta una malattia concomitante potenzialmente letale con un’aspettativa di vita <1 mese.
    10. Il soggetto presenta una pneumopatia sottostante significativa che desta confusione nella valutazione dell’episodio di infezione da RSV o qualsiasi condizione che, secondo il parere dello sperimentatore, impedirebbe la partecipazione a questo studio o interferirebbe con la valutazione di un qualsiasi endpoint dello studio.
    11. Il soggetto è stato precedentemente arruolato in uno studio clinico di ALX-0171 (compreso lo studio attuale ALX0171-C204).
    12. Il soggetto presente ipersensibilità nota al farmaco in studio o a qualsiasi eccipiente del farmaco in studio.
    E.5 End points
    E.5.1Primary end point(s)
    Time-weighted average change from baseline to day 7 in log RSV nasal viral load (as measured by quantative reverse transcriptase polymerase chain reaction)
    Variazione media ponderata in base al tempo, espressa in log10, misurata dal valore basale al Giorno 7 per quanto riguarda la carica virale nasale di RSV (rilevata mediante PCR quantitativa con trascrittasi inversa, RT-qPCR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 7
    valore basale
    giorno 7
    E.5.2Secondary end point(s)
    - The safety profile of ALX-0171 (as assessed by AEs, physical
    examination, clinical laboratory assessments, vital signs and oxygen
    - Nasal RSV load parameters over time, including time to undetectable
    - Clinical stabilization, defined as respiratory rate <25/min and stable
    oxygen saturation >92% on room air for at least 12 hours, by Day 7 and
    up to EOS visit for subjects with LRTI at baseline
    - Percentage of subjects needing any supplemental oxygen therapy and
    percentage of subjects needing >2 l/minute oxygen supplementation
    through Day 7 and up to EOS visit
    - Number of day without oxygen or without oxygen supplementation at
    levels <= 2L/minute through Day7 and up to EOS visit
    - Progression to LRTI disease in subjects presenting with URTI at
    baseline by Day 7 and up to EOS visit. Progression to LRTI will be
    conducted by the investigator based on standard of care clinical,
    radiological and laboratory assessments
    - The PK parameters of ALX-0171 (serum concentrations of ALX-0171,
    area under the curve, Cmax, Tmax)
    - ADA serum concentrations over time
    • Profilo di sicurezza di ALX-0171 (valutato in base a EA, esame obiettivo, valutazioni di laboratorio, segni vitali e saturazione d’ossigeno)
    • Parametri della carica nasale di RSV nel tempo, compreso il tempo riguardante la dispersione non rilevabile del visus
    • Stabilizzazione clinica definita come frequenza respiratoria <25/min e saturazione d’ossigeno stabile >92% in atmosfera ambiente per almeno 12 ore, entro il Giorno 7 e fino alla visita EOS per i soggetti con LRTI al valore basale
    • Percentuale di soggetti che necessitano di qualsiasi terapia con ossigeno supplementare e percentuale di soggetti che necessitano di >2 l/min di ossigeno supplementare fino al Giorno 7 e alla visita EOS
    • Numero di giorni senza ossigeno o con ossigeno supplementare a livelli ≤2 l/min fino al Giorno 7 e alla visita EOS
    • Progressione verso malattia LRT nei soggetti che si presentano con URTI al valore basale entro il Giorno 7 e fino alla visita EOS. La progressione verso LRTI sarà accertata dallo sperimentatore in base a valutazioni cliniche, radiologiche e di laboratorio previste dalla terapia standard.
    • Parametri di PK di ALX-0171 (concentrazioni sieriche di ALX-0171, area sotto la curva [AUC], concentrazione massima [Cmax], tempo al raggiungimento della concentrazione massima [tmax], concentrazione minima [Cmin])
    • Concentrazioni sieriche di ADA nel tempo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 42
    dal giorno 1 al giorno 42
    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. 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    United States
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 35
    F.4.2.2In the whole clinical trial 75
    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 - patients will receive standard of care after study end
    Nessuno - I pazienti riceveranno la terapia standard dopo la fine dello studio
    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 Decision2018-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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