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    Summary
    EudraCT Number:2019-002709-23
    Sponsor's Protocol Code Number:PLN-74809-IPF-202
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-002709-23
    A.3Full title of the trial
    A randomized, double-blind, dose-ranging, placebo-controlled Phase 2a evaluation of the safety, tolerability and pharmacokinetics of PLN 74809 in participants with idiopathic pulmonary fibrosis (IPF) (INTEGRIS-IPF)
    Studio di dose-ranging, randomizzato, in doppio cieco, controllato con placebo di fase 2a per la valutazione della sicurezza, tollerabilità e farmacocinetica di PLN-74809 in partecipanti affetti da fibrosi polmonare idiopatica (FPI) (INTEGRIS-IPF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy, safety and pharmacokinetics of PLN-74809 in participants with idiopathic pulmonary fibrosis
    Studio per valutare l'efficacia, la sicurezza e la farmacocinetica di PLN-74809 in partecipanti affetti da fibrosi polmonare idiopatica
    A.3.2Name or abbreviated title of the trial where available
    INTEGRIS-IPF
    INTEGRIS-IPF
    A.4.1Sponsor's protocol code numberPLN-74809-IPF-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04396756
    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 SponsorPliant Therapeutics 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 supportPliant Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPliant Therapeutics Inc.
    B.5.2Functional name of contact pointMonica Sandberg
    B.5.3 Address:
    B.5.3.1Street Address260 Littlefield Avenue
    B.5.3.2Town/ city260 Littlefield Avenue
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016504816931
    B.5.5Fax number0016504816776
    B.5.6E-mailMsandberg@pliantrx.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 namePLN-74809
    D.3.2Product code [PLN-74809]
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codePLN-74809
    D.3.9.3Other descriptive namePLN-74809-000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 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 placeboTablet
    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
    idiopathic pulmonary fibrosis
    fibrosi polmonare idiopatica
    E.1.1.1Medical condition in easily understood language
    idiopathic pulmonary fibrosis
    fibrosi polmonare idiopatica
    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 SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of the safety and tolerability of PLN-74809 following daily
    administration for up to 12 weeks
    Valutazione della sicurezza e tollerabilità di PLN-74809 dopo somministrazione
    giornaliera fino a un massimo di 12 settimane
    E.2.2Secondary objectives of the trial
    Assessment of pharmacokinetics (PK) of PLN-74809
    Valutazione della farmacocinetica (PK) di PLN-74809
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants, aged 40 years or older.
    2. Diagnosis of IPF for up to 5 years prior to screening based on
    ATS/ERS/JRS/ALAT 2018 guidelines (Raghu et al, 2018)
    Note: If IPF diagnosis is within >3 to =5 years at screening, the
    participant must have evidence of progression within the last 24 months,
    as defined by decline in FVC percent predicted based on a relative
    decline of = 5%
    3. FVC percent of predicted =45%; historical FVC for entry in the study is
    permitted if within 1 month of screening
    4. Diffusing capacity for carbon monoxide (DLco) (hemoglobin-adjusted)
    =30%%; historical DLco for entry in the study is permitted if within 1
    month of screening
    5. Participants currently receiving treatment for IPF with nintedanib or
    pirfenidone are allowed, provided these drugs have been given at a
    stable dose for at least 3 months before the Screening Visit and are
    expected to remain unchanged during the study stable dose is defined as
    the highest dose tolerated by the participant during = 3 months)
    6. Estimated glomerular filtration rate = 50 mL/min, according to the
    Cockcroft-Gault equation
    7. Female participants of non-childbearing potential must be either
    surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy,
    and/or bilateral oophorectomy at least 26 weeks before the Screening
    Visit) or post-menopausal, defined as spontaneous amenorrhea for at
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    least 2 years
    8. Female participants of childbearing potential (i.e., ovulating, premenopausal,
    and not surgically sterile) and all male participants with
    sexual partners of childbearing potential must use highly effective
    methods of birth control during their participation in the study and for
    90 days after the last administration of study drug. Hormonal
    contraceptives are not allowed. Highly effective methods of birth control
    are defined as those with 99% or greater efficacy.
    9. Participants must agree to abstain from sperm or egg donation
    through 90 days after administration of the last dose of study drug
    10. Able to read and sign a written informed consent form (ICF)
    1. Partecipanti di età pari o superiore a 40 anni.
    2. Diagnosi di FPI formulata fino a 5 anni prima dello screening sulla base delle linee
    guida ATS/ERS/JRS/ALAT del 2018 (Raghu et al, 2018)
    Nota: se la diagnosi di FPI risale a > 3 e = 5 anni prima dello screening, il
    partecipante deve presentare evidenza di progressione negli ultimi 24 mesi,
    definita dal declino dei valori percentuali predetti della FVC basati su un declino
    relativo = 5%
    3. percentuale di FVC dei valori predetti = 45%; per l'ammissione allo studio è ammessa
    una FVC storica se rientra nel mese precedente allo screening
    4. Capacità di diffusione per il monossido di carbonio (DLco) (aggiustata per
    l'emoglobina) = 30%; per l'ammissione allo studio è ammessa una DLco storica se
    rientra nel mese precedente allo screening
    5. Sono ammessi partecipanti attualmente in terapia per FPI con nintedanib o
    pirfenidone, a condizione che questi farmaci siano stati somministrati a una dose
    stabile perlomeno nei 3 mesi precedenti alla visita di screening e che non siano
    previste variazioni durante lo studio (per dose stabile si intende la dose massima
    tollerata dal partecipante durante un periodo = 3 mesi)
    6. Velocità di filtrazione glomerulare stimata = 50 mL/min, secondo l'equazione di Cockcroft-Gault
    7. Le partecipanti femmine non potenzialmente fertili devono essere chirurgicamente
    sterili (isterectomia, legatura tubarica bilaterale, salpingectomia e/o ooforectomia
    bilaterale effettuata perlomeno nelle 26 settimane precedenti alla visita di screening)
    o in postmenopausa, definita come amenorrea spontanea da almeno 2 anni.
    8. Le partecipanti femmine in età fertile (ovulanti, in premenopausa e non
    chirurgicamente sterili) e tutti i partecipanti maschi le cui partner sessuali sono in età
    fertile devono far uso di metodi contraccettivi altamente efficaci durante la
    partecipazione allo studio e per i 90 giorni successivi all'ultima somministrazione del
    farmaco sperimentale. Per metodi contraccettivi altamente efficaci si intendono i
    metodi con una percentuale di efficacia pari o superiore al 99%
    9. I partecipanti devono acconsentire ad astenersi dalla donazione di ovuli o sperma per
    un periodo rispettivamente di 30 o 90 giorni dalla somministrazione dell'ultima dose
    del farmaco sperimentale
    10. I partecipanti devono essere capaci di leggere e firmare il modulo di consenso
    informato scritto
    E.4Principal exclusion criteria
    1. Receiving any non-approved agent intended for treatment of fibrosis
    in IPF
    2. Forced expiratory volume during the first second (FEV1) over the
    forced vital capacity (FVC) ratio (FEV1/FVC ratio) <0.7 at Screening
    3. Clinical evidence of active infection, including but not limited to
    bronchitis, pneumonia, or sinusitis that can affect FVC measurement
    during Screening or at Randomization.
    4. Any other condition that prevents the correct assessment of
    spirometry performance (for example a broken rib or chest pain of other
    origin that prevents adequate forced breathing)
    5. Known acute IPF exacerbation or suspicion by the Investigator of
    such, within 6 months of Screening
    6. The extent of fibrotic changes is greater than the extent of
    emphysema on the most recent HRCT scan (as determined by central
    reader)
    7. Diagnosis of severe pulmonary hypertension
    8. Smoking of any kind (not limited to tobacco) within 3 months of
    Screening or unwilling to avoid smoking throughout the study
    9. Lower respiratory tract infection requiring antibiotics within 4 weeks
    prior to screening and/or during the screening period
    10. History of malignancy within the past 5 years or ongoing malignancy
    other than basal cell carcinoma, resected noninvasive cutaneous
    squamous cell carcinoma, or treated cervical carcinoma in situ
    11. Hepatic impairment or end-stage liver disease
    12. Renal impairment or end-stage kidney disease requiring dialysis
    13. History of unstable or deteriorating cardiac or pulmonary disease
    (other than IPF) within the 6 months prior to Screening, including but
    not limited to the following:
    a. Unstable angina pectoris or myocardial infarction
    b. Congestive heart failure requiring hospitalization during the 6 months
    prior to
    Screening
    c. Uncontrolled clinically significant arrhythmias
    d. Significant electrocardiogram (ECG) abnormalities, including but not
    limited to, QT interval corrected for heart rate using Fridericia's formula
    (QTcF) >450 msec for males or >460 msec for females at the Screening
    visit (including Day -1) or prior to administration of the initial dose of
    study drug.
    14. Any of the following liver function test criteria above specified limits:
    total bilirubin >1.5× the upper limit of normal (ULN); aspartate
    aminotransferase (AST) or alanine aminotransferase (ALT) >3× ULN;
    alkaline phosphatase >2.5× ULN.
    Note: participants currently receiving nintedanib or pirfenidone as IPF
    SoC treatment, who have previously presented any liver function test
    elevations associated with nintedanib or pirfenidone treatment greater
    than that described above or resulting in dose reduction, treatment
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    interruption, or discontinuation are not eligible.
    15. Any of the following at Screening: hemoglobin <10.0 g/dL, or
    neutrophils <1500 /mm3, or platelets <100.000 /mL
    16. Pregnant or lactating females
    17. Daily use of phosphodiesterase-5 (PDE-5) inhibitor drugs (e.g.,
    sildenafil, tadalafil, other) (Note: Intermittent use for erectile
    dysfunction is allowed.)
    18. A medical or surgical condition known to affect drug absorption (e.g.,
    major gastric surgery)
    19. Surgical procedures planned to occur during the study period
    20. Uncontrolled systemic arterial hypertension
    21. Has participated in a clinical trial with an investigational agent in the
    30 days prior to Screening
    22. Likely to have lung transplantation during the study (being on
    transplantation list is acceptable)
    23. Any medical condition that, in the opinion of the Investigator, may
    make candidates not suitable for the study, including, but not limited to,
    suspected infection with COVID-19
    24. Hypersensitivity to PLN-74809 or to any of the excipients, or placebo
    1. Soggetti trattati con qualsiasi agente non approvato, indicato per il trattamento della
    fibrosi nella FPI
    2. Rapporto tra volume espiratorio forzato nel primo secondo (FEV1) e FVC (rapporto
    FEV1/FVC) < 0,7 allo screening
    3. Evidenza clinica di infezione in atto, compresa a mero titolo esemplificativo
    bronchite, polmonite o sinusite, che possa influire sulla misurazione della FVC
    durante lo screening o alla randomizzazione
    4. Qualsiasi altra condizione medica che impedisca la valutazione corretta della
    spirometria (ad esempio frattura alle costole o dolore toracico di altra origine che
    impedisca un'adeguata respirazione forzata)
    5. Nota o, secondo l'opinione dello sperimentatore, sospetta esacerbazione acuta della
    FPI nei 6 mesi precedenti allo screening
    6. L'entità delle variazioni fibrotiche è risultata maggiore di quella dell'enfisema alla
    HRCT più recente (come determinato dal lettore centrale)
    7. Diagnosi di ipertensione polmonare severa
    8. Fumatori di qualsiasi tipo (non solo tabacco) nei 3 mesi precedenti allo screening o
    non disposti ad astenersi dal fumo per l'intera durata dello studio
    9. Infezione delle basse vie respiratorie necessitante di antibiotici nelle 4 settimane
    precedenti allo screening e/o durante il periodo dello screening
    10. Anamnesi di neoplasia maligna negli ultimi 5 anni o presenza di neoplasia maligna
    diversa da carcinoma basocellulare, carcinoma cutaneo spinocellulare non invasivo
    resecato o carcinoma cervicale trattato in situ
    11. Compromissione epatica o epatopatia allo stadio terminale
    12. Compromissione renale o malattia renale allo stadio terminale necessitante di dialisi
    13. Anamnesi di cardiopatia o pneumopatia (diversa dalla FPI) instabile o in
    deterioramento nei 6 mesi precedenti allo screening, comprese a mero titolo
    esemplificativo le seguenti patologie:
    a. angina pectoris instabile o infarto miocardico
    b. insufficienza cardiaca congestizia necessitante il ricovero nei 6 mesi precedenti
    allo screening
    c. aritmie non controllate clinicamente significative
    d. anomalie clinicamente importanti dell'elettrocardiogramma (ECG), compreso, a
    mero titolo esemplificativo, l'intervallo QT corretto per la frequenza cardiaca
    > 450 msec in soggetti maschi o > 460 msec in soggetti femmine (secondo la
    formula di Fridericia, QTcF) alla visita di screening (compreso il Giorno -1) o
    precedenti alla somministrazione della dose iniziale del farmaco sperimentale.
    14. Uno qualsiasi dei seguenti criteri degli esami di funzionalità epatica che superino i
    limiti specificati: bilirubina totale > 1,5 volte il limite superiore della norma (ULN),
    aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) > 3 volte l'ULN,
    fosfatasi alcalina > 2,5 volte l'ULN.
    Nota: non sono eleggibili i partecipanti attualmente in terapia con nintedanib o
    pirfenidone quale SoC per la FPI, che in precedenza avevano manifestato un
    aumento dei parametri di funzionalità epatica associato al trattamento con
    nintedanib o pirfenidone superiore ai limiti sopra descritti o che abbia comportato
    la riduzione della dose, l'interruzione o la sospensione del trattamento
    15. Uno qualsiasi dei seguenti referti rilevati allo screening: emoglobina < 10,0 g/dL o
    neutrofili < 1500 /mm3 o piastrine < 100.000/mL
    16. Donne in gravidanza o che allattano.
    17. Uso giornaliero di inibitori della fosfodiesterasi-5 (PDE-5) (ad es., sildenafil,
    tadalafil, altro) (Nota: è ammesso l'uso intermittente per la disfunzione erettile)
    18. Una condizione medica o chirurgica il cui effetto sull'assorbimento del farmaco sia
    noto (ad es., intervento di chirurgia gastrica maggiore)
    19. Interventi chirurgici elettivi da effettuarsi durante il periodo dello studio.
    20. Ipertensione arteriosa sistemica non controllata
    21. Soggetti che hanno partecipato a uno studio clinico con un agente sperimentale nei
    30 giorni precedenti allo screening
    E.5 End points
    E.5.1Primary end point(s)
    Nature and proportion of AEs between PLN-74809 and placebo groups
    (descriptive)
    Safety data from all participants who received at least one dose of study
    drug will be incorporated into the final safety analysis. Further details of
    the safety analyses will be provided in the SAP. AEs will be collected
    from the time the participant signs the ICF until the last study visit.
    Treatment-emergent adverse events (TEAEs) are defined as AEs that
    emerged or worsened in severity after the first administration of study
    drug.
    Natura e proporzione degi eventi avversi tra i gruppi PLN-74809 e placebo (descrittivi)
    I dati di sicurezza di tutti i partecipanti che hanno ricevuto almeno una dose del farmaco in studio saranno incorporati nell'analisi di sicurezza finale. Ulteriori dettagli sulle analisi di sicurezza saranno forniti nel SAP. Gli eventi avversi verranno raccolti dal momento in cui il partecipante firma l'ICF fino all'ultima visita di studio.
    Gli eventi avversi emergenti dal trattamento (TEAE) sono definiti come eventi avversi che sono emersi o sono peggiorati in gravità dopo la prima somministrazione del farmaco in studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    week 12
    E.5.2Secondary end point(s)
    a. Secondary Pharmacokinetic Endpoints
    Plasma PLN-74809 concentrations (total and unbound concentrations) at
    each sampling time point will be presented in listings and descriptive
    summary statistics by dose and visit. The data will also be presented
    graphically.
    b. Secondary Pharmacodynamic Endpoints
    Urine, plasma and serum samples will be analyzed for biomarkers
    (presence or actual concentration). These samples will be used to
    determine the levels of these markers in participants and the
    relationship between these markers. Results will be presented by
    listings, descriptive summary statistics and in graphical form by treatment and dose and expressed as the relative change (and or absolute) for each participant.
    a. Endpoint farmacocinetici secondari
    Le concentrazioni plasmatiche di PLN-74809 (concentrazioni totali e non legate) in ciascun punto temporale di campionamento saranno presentate in elenchi e statistiche riassuntive descrittive per dose e visita. I dati verranno anche presentati graficamente.



    b. Endpoint farmacodinamici secondari
    Campioni di urina, plasma e siero saranno analizzati per biomarcatori (presenza o concentrazione effettiva). Questi campioni verranno utilizzati per determinare i livelli di questi marcatori nei partecipanti e la relazione tra questi marcatori. I risultati saranno presentati da elenchi, statistiche riassuntive descrittive e in forma grafica per trattamento e dose ed espressi come variazione relativa (eo assoluta) per ciascun partecipante.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12
    week 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 trial4
    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 EEA3
    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
    Australia
    Canada
    New Zealand
    United States
    Belgium
    France
    Germany
    Italy
    Netherlands
    United Kingdom
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days9
    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: 84
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 84
    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)
    Subsequent treatments of the study subject will be at the discretion of
    the investigator in accordance to standard care.
    I trattamenti successivi del soggetto in studio saranno a discrezione di
    lo sperimentatore secondo le cure standard.
    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 Decision2020-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-09
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