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    Summary
    EudraCT Number:2021-001498-21
    Sponsor's Protocol Code Number:A011-14
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-10
    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 number2021-001498-21
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality
    Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo volto a valutare Sotatercept in aggiunta alla terapia di base massima tollerata in partecipanti affetti da ipertensione polmonare arteriosa (PAH) di classe funzionale (FC) III o FC IV secondo l’Organizzazione Mondiale della Sanità (OMS) ad alto rischio di mortalità
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality
    Studio per valutare Sotatercept in partecipanti con PAH FC III o FC IV (OMS) ad alto rischio di mortalità
    A.3.2Name or abbreviated title of the trial where available
    A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality
    Studio per valutare Sotatercept in partecipanti con PAH FC III o FC IV (OMS) ad alto rischio di mort
    A.4.1Sponsor's protocol code numberA011-14
    A.5.4Other Identifiers
    Name:INDNumber:136150
    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 SponsorACCELERON PHARMA 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 supportAcceleron Pharma Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcceleron Pharma Inc.
    B.5.2Functional name of contact pointSaraBeth Hahn
    B.5.3 Address:
    B.5.3.1Street Address128 Sidney Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number0014847675150
    B.5.6E-mailshahn@acceleronpharma.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2369
    D.3 Description of the IMP
    D.3.1Product nameSotatercept
    D.3.2Product code [ACE-011]
    D.3.4Pharmaceutical form Lyophilisate for solution for 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.3.9.1CAS number 1001080-50-7
    D.3.9.2Current sponsor codeACE-011
    D.3.9.4EV Substance CodeSUB179718
    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.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 placeboLyophilisate for solution for injection
    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
    Pulmonary Arterial Hypertension (PAH)
    Ipertensione polmonare arteriosa (PAH)
    E.1.1.1Medical condition in easily understood language
    Cardiovascular Disease
    Malattia cardiovascolare
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    The objective of this study is to evaluate the effects of sotatercept
    treatment (plus maximum tolerated background PAH therapy) versus
    placebo (plus maximum tolerated background PAH therapy) on time to
    first event of all-cause death, lung transplantation, or PAH worsening
    related hospitalization of = 24 hours, in participants with WHO FC III
    or FC IV PAH at high risk of mortality.
    L'obiettivo di questo studio è quello di valutare gli effetti del trattamento con sotatercept (più la terapia di base massima tollerata per la PAH) rispetto al placebo (più la terapia di base massima tollerata per la PAH) sul tempo al primo evento di morte per tutte le cause, trapianto di polmone o ricovero ospedaliero legato al peggioramento della PAH di = 24 ore, in partecipanti con PAH FC III o FC IV secondo l'OMS, ad alto rischio di mortalità.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible participants must meet all of the following inclusion criteria to
    be enrolled in the study:
    1. Age 18 to 75 years, inclusive
    2. Documented diagnostic right heart catheterization prior to screening
    confirming the diagnosis of WHO PAH Group 1 in any of the following
    subtypes:
    • Idiopathic PAH
    • Heritable PAH
    • Drug/toxin-induced PAH
    • PAH associated with CTD
    • PAH associated with simple, congenital systemic-to-pulmonary shunts
    at least 1 year following repair
    3. Symptomatic PAH classified as WHO FC III or IV
    4. REVEAL Lite 2 risk score of = 10
    5. Right heart catheterization performed during screening (or within 2
    weeks prior to screening, if done at the clinical study site) documenting
    a minimum PVR of = 5 Wood units and a pulmonary capillary wedge
    pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of =
    15 mmHg
    6. Clinically stable and on stable doses of maximum tolerated (per
    investigator's judgment) double or triple background PAH therapies for
    at least 30 days prior to screening
    7. Females of childbearing potential must:
    • Have 2 negative urine or serum pregnancy tests as verified by the
    investigator prior to starting study therapy; must agree to ongoing urine
    or serum pregnancy testing during the course of the study and until 8
    weeks after the last dose of the study drug
    • If sexually active, have used, and agree to use highly
    effective contraception without interruption; for at least28 days prior to
    starting the investigational product, during the study (including dose
    interruptions), and for 16 weeks (112 days) after discontinuation of
    study treatment
    • Refrain from breastfeeding a child or donating blood, eggs, or ovum for
    the duration of the study and for at least 16 weeks (112 days) after the
    last dose of study treatment
    8. Male participants must:
    • Agree to use a condom, defined as a male latex condom or nonlatex
    condom NOT made out of natural (animal) membrane (e.g.,
    polyurethane), during sexual contact with a pregnant female or a female
    of childbearing potential while participating in the study, during dose
    interruptions, and for at least 16 weeks (112 days) following
    investigational product discontinuation, even if he has undergone a
    successful vasectomy
    • Refrain from donating blood or sperm for the duration of the study and
    for 16 weeks (112 days) after the last dose of study treatment
    9. Ability to adhere to study visit schedule and understand and
    comply with all protocol requirements
    10. Ability to understand and provide written informed consent
    I partecipanti eleggibili devono soddisfare tutti i seguenti criteri di inclusione per essere arruolati nello studio:
    1. Età compresa tra i 18 e i 75 anni, inclusi
    2. Cateterismo del cuore destro a scopo diagnostico documentato prima dello screening che confermi la diagnosi di PAH del gruppo 1 OMS in uno dei seguenti sottotipi:
    • PAH idiopatica
    • PAH ereditaria
    • PAH indotta da farmaci/tossine
    • PAH associata a CTD
    • PAH associata a shunt semplici, congeniti sistemico-polmonari almeno 1 anno dopo la riparazione
    3. PAH sintomatica classificata come FC III o IV secondo l’OMS
    4. Punteggio di rischio REVEAL Lite 2 = 10
    5. Cateterismo del cuore destro eseguito durante lo screening (o entro 2 settimane prima dello screening, se eseguito nel centro dello studio clinico) che documenta una PVR minima di = 5 unità Wood e una pressione capillare polmonare di incuneamento (PCWP) o una pressione ventricolare sinistra di fine diastole (LVEDP) di = 15 mmHg
    6. Clinicamente stabili e riceventi dosi stabili di terapie PAH di base massime tollerate (a giudizio dello sperimentatore) a due o tre farmaci per almeno 30 giorni prima dello screening
    7. Le donne in età fertile devono:
    • Avere 2 test di gravidanza negativi sulle urine o sul siero come verificato dallo sperimentatore prima di iniziare la terapia in studio; accettare di sottoporsi a test di gravidanza sulle urine o sul siero su base continuativa durante il corso dello studio e fino a 8 settimane dopo l'ultima dose del farmaco in studio
    • Se sessualmente attive, aver utilizzato e accettare di utilizzare una contraccezione altamente efficace senza interruzioni per almeno
    28 giorni prima di iniziare il prodotto sperimentale, durante lo studio (comprese le interruzioni della dose) e per 16 settimane (112 giorni) dopo l'interruzione del trattamento in studio
    • Astenersi dall'allattare o dal donare sangue o ovuli per tutta la durata dello studio e per almeno
    16 settimane (112 giorni) dopo l'ultima dose del trattamento in studio
    8. I partecipanti di sesso maschile devono:
    • Accettare di usare un preservativo, definito come preservativo maschile in lattice o non in lattice NON realizzato in membrana naturale (animale) (ad es. poliuretano), durante il contatto sessuale con una donna in gravidanza o una donna potenzialmente fertile durante la partecipazione allo studio, durante le interruzioni della dose e per almeno 16 settimane (112 giorni) dopo l'interruzione del prodotto in studio, anche in caso di vasectomia eseguita con successo
    • Astenersi dal donare sangue o sperma per tutta la durata dello studio e per 16 settimane (112 giorni) dopo l'ultima dose del trattamento in studio
    9. Essere disposti ad aderire al programma delle visite dello studio nonché comprendere e rispettare tutti i requisiti del protocollo
    10. Essere in grado di comprendere e fornire il consenso informato scritto
    E.4Principal exclusion criteria
    1. Diagnosis of PAH WHO Groups 2, 3, 4, or 5
    2. Diagnosis of the following PAH Group 1 subtypes: human
    immunodeficiency virus-associated PAH and PAH associated
    with portal hypertension
    3. Diagnosis of pulmonary veno-occlusive diseases or pulmonary
    capillary hemangiomatosis or overt signs of capillary and/or venous
    involvement
    4. Hemoglobin at screening above gender-specific upper limit of
    normal (ULN), per local laboratory test
    5. Baseline platelet count < 50,000/mm3 (< 50.0 x 109/L) at
    screening
    6. Baseline systolic blood pressure < 85 mmHg at screening
    7. Pregnant or breastfeeding women
    8. Any of the following clinical laboratory values at the Screening
    Visit:
    • Estimated glomerular filtration rate < 30 mL/min/m2 (as
    defined by the Modification of Diet in Renal Disease Study
    equation)
    • Serum alanine aminotransferase or aspartate aminotransferase levels
    > 3 × ULN or total bilirubin > 2.0 × ULN
    9. Currently enrolled in or have completed any other investigational
    product study within 30 days for small-molecule drugs or within 5 halflives
    for biologics prior to the date of signed informed consent
    10. Prior exposure to or known allergic reaction to sotatercept
    (ACE-011) or luspatercept (ACE-536)
    11. History of pneumonectomy
    12. Pulmonary function test values of forced vital capacity < 60%
    predicted within 1 year prior to the Screening Visit
    13. Untreated obstructive sleep apnea
    14. History of known pericardial constriction
    15. History of restrictive or congestive cardiomyopathy
    16. Electrocardiogram (ECG) with Fridericia's corrected QT interval
    (QTcF) > 450 ms (or > 500 ms if right bundle branch block is present)
    during the Screening Period
    17. Personal or family history of long QT syndrome or sudden cardiac
    death
    18. Left ventricular ejection fraction < 50% on historical echocardiogram
    within 1 year prior to the Screening Visit
    19. Any current or prior history of symptomatic coronary disease (prior
    myocardial infarction, percutaneous coronary
    intervention, coronary artery bypass graft surgery, or cardiac anginal
    chest pain) in the past 6 months prior to the Screening Visit
    20. Cerebrovascular accident within 3 months prior to the Screening
    Visit
    21. Significant (= 2+ regurgitation) mitral regurgitation or aortic
    regurgitation valvular disease
    1. Diagnosi di PAH dei gruppi 2, 3, 4 o 5 OMS
    2. Diagnosi dei seguenti sottotipi di PAH del gruppo 1: PAH associata al virus dell'immunodeficienza umana e PAH associata a ipertensione portale
    3. Diagnosi di malattie veno-occlusive polmonari o emangiomatosi capillare polmonare o segni evidenti di coinvolgimento capillare e/o venoso
    4. Emoglobina allo screening superiore al limite superiore della norma (ULN) specifico per il sesso, secondo il test di laboratorio locale
    5. Conta piastrinica al basale < 50.000/mm3 (< 50,0 x 109/L) allo screening
    6. Pressione sanguigna sistolica al basale < 85 mmHg allo screening
    7. Donne in gravidanza o allattamento
    8. Uno qualsiasi dei seguenti valori clinici di laboratorio alla visita di Screening
    • Velocità di filtrazione glomerulare stimata < 30 mL/min/m2 (come definita dall’equazione di Modifica della dieta nella malattia renale)
    • Livelli sierici di alanina aminotransferasi o aspartato aminotransferasi > 3 × ULN o bilirubina totale > 2,0 × ULN
    9. Attualmente arruolato o che abbia completato qualsiasi altro studio su prodotti sperimentali entro 30 giorni per i farmaci a piccole molecole o entro 5 emivite per i farmaci biologici prima della data della firma del consenso informato
    10. Precedente esposizione o reazione allergica nota a sotatercept (ACE-011) o luspatercept (ACE-536)
    11. Anamnesi di pneumonectomia
    12. Valori del test di funzionalità polmonare della capacità vitale forzata < 60% previsto entro 1 anno prima della visita di Screening
    13. Apnea ostruttiva del sonno non trattata
    14. Anamnesi di costrizione pericardica nota
    15. Anamnesi di cardiomiopatia restrittiva o congestizia
    16. Elettrocardiogramma (ECG) con intervallo QT corretto usando la formula di Fridericia (QTcF) > 450 ms (o > 500 ms se è presente un blocco di branca destra) durante il periodo di Screening
    17. Anamnesi personale o familiare di sindrome del QT lungo o morte cardiaca improvvisa
    18. Frazione di eiezione ventricolare sinistra < 50% su ecocardiogramma storico entro 1 anno prima della visita di Screening
    19. Qualsiasi anamnesi precedente o condizione attuale di malattia coronarica sintomatica (precedente infarto miocardico, intervento coronarico percutaneo, intervento chirurgico di bypass dell'arteria coronarica o dolore toracico anginoso cardiaco) negli ultimi 6 mesi prima della visita di Screening
    20. Accidente cerebrovascolare nei 3 mesi precedenti la visita di Screening
    21. Significativo (= 2+ rigurgito) rigurgito mitralico o malattia valvolare da rigurgito aortico.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the time to first event of all-cause
    death, lung transplantation, or PAH worsening-related hospitalization
    of = 24 hours.
    L'endpoint primario di efficacia è il tempo al primo evento di morte per tutte le cause, trapianto di polmone o ricovero legato al peggioramento della PAH di = 24 ore.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint, time to first event of all-cause death, lung
    transplantation, or PAH worsening-related hospitalization of = 24 hours,
    will be analyzed using the log-rank test with randomization factors as
    strata. The Cui-Hung-Wang (CHW) method will be used to control the
    overall Type I error rate. If there is no increase in the number of
    events and sample size following the planned interim analysis, then the
    CHW method will be the same as a conventional analysis of this data.
    The Chen-DeMets-Lan method will be used as a supportive analysis to
    the CHW method. The point estimate of the hazard ratio with 95% CI
    will be estimated by a Cox regression model stratified by the
    randomization factors.
    L'endpoint primario, tempo al primo evento di morte per tutte le cause, trapianto di polmone o ricovero legato al peggioramento della PAH di = 24 ore, verrà analizzato utilizzando un log-rank test stratificato con fattori di randomizzazione come strati.
    Il metodo Cui-Hung-Wang (CHW) sarà utilizzato per controllare il tasso di errore globale di tipo I. Se non ci sarà aumento del numero di eventi e della dimensione del campione in seguito all'analisi ad interim prevista, il metodo CHW sarà lo stesso di un'analisi convenzionale di questi dati.
    Il metodo Chen-DeMets-Lan sarà utilizzato come analisi di supporto al metodo CHW.
    La stima puntuale del rapporto di rischio con un IC al 95% sarà stimata da un modello di regressione di Cox stratificato con i fattori di randomizzazione.
    E.5.2Secondary end point(s)
    The secondary endpoints are ranked as follows:
    1. Overall survival
    2. Transplant-free survival
    3. Proportion of participants who experienced a mortality event at EOS
    4. Change from baseline REVEAL Lite 2 risk score at Week 24
    5. Proportion of participants achieving a low intermediate (= 7) REVEAL Lite 2 risk score at Week 24
    6. Change from baseline in NT-proBNP levels at Week 24
    7. Change from baseline in mean pulmonary artery pressure (mPAP) at Week 24
    8. Change from baseline in PVR at Week 24
    9. Proportion of participants who improve in WHO Fc at the end of the DBPC Treatment Period
    10. Change from baseline in 6MWD at Week 24
    11. Change from baseline in cardiac output (CO) at Week 24
    12. Change from baseline in EuroQoL-5 dimensions scale 5 levels (EQ-5D-5L) index score at Week 24
    Gli endpoint secondari sono classificati come segue:
    1. Sopravvivenza globale
    2. Sopravvivenza libera da trapianto
    3. Percentuale di partecipanti che hanno avuto un evento di mortalità all'EOS
    4. Variazione rispetto al basale nel punteggio di rischio REVEAL Lite 2 alla Settimana 24
    5. Percentuale di partecipanti che hanno ottenuto un punteggio di rischio REVEAL Lite 2 basso o intermedio (= 7) alla Settimana 24
    6. Variazione rispetto al basale nei livelli NT-proBNP alla Settimana 24
    7. Variazione rispetto al basale nella pressione media dell'arteria polmonare (mPAP) alla Settimana 24
    8. Variazione rispetto al basale nella PVR alla Settimana 24.
    9. Percentuale di partecipanti che migliorano nella FC dell'OMS alla fine del periodo di Trattamento DBPC
    10. Variazione rispetto al basale nella 6MWD alla Settimana 24
    11. Variazione rispetto al basale nella gittata cardiaca (CO) alla settimana 24
    12. Variazione rispetto al basale nel punteggio dell'indice della scala EuroQoL-5 dimensioni 5 livelli (EQ-5D-5L) alla Settimana 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    The first-ranked secondary endpoint of overall survival will be measured at the end of the double blind placebo-controlled period (up to approximately 46 months) at the primary analysis period which will occur when either 92 events occur if promising zone is not triggered or when 128 events occur if promising zone is triggered. Transplant-free survival and proportion of participants who experienced a mortality event will be measured at the end of the study (up to approximately 49 months). All other secondary endpoints will be measured at week 24.
    Il primo endpoint secondario di sopravvivenza globale verrà misurato all fine del periodo di studio in doppio cieco controllato con placebo (a circa 46 mesi), nel periodo dell'analisi primaria che avverrà o quando saranno stati raggiunti i 92 eventi, se la zona promettente non sarà stata raggiunta, o al raggiungimento dei 128 eventi sel la zona promettente sarà stata raggiunta. La sopravvivenza libera da trapianto e la proporzione di partecipanti che avranno avuto un evento di mortalità verranno misurate alla fine dello studio (a circa 49 mesi). Tutti gli altri endpoint secondari saranno misurati alla settimana 24.
    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 Yes
    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) 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 Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Belgium
    Canada
    France
    Germany
    Israel
    Italy
    Mexico
    Netherlands
    Spain
    United Kingdom
    United States
    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
    A participant is considered to have completed the study if he/she has
    completed all phases of the study, including the EOT and/or EOS Visits.
    Participants who discontinue the study early or decline enrollment into
    the LTFU Study A011-12 (SOTERIA) will be asked to return to the clinic
    for the EOS Visit.
    The end of the study is defined as when the last participant completes
    the last visit (LVLS).
    Un partecipante si considera avere completato lo studio quando ha competato tutte le fasi dello studio, incluse le visite di EOT e/o EOS. Ai partecianti che interrompono lo studio precocemente o rifiutano l'arruolamento nello studio di LTFU A011-12 (SOTERIA) verrà chiesto di ritornare al centro clinico per eseguire la visita di EOS.
    La fine dello studio è definita come quando l'ultimo paziente completa l'ultima visita (LVLS).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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: 83
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 83
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 166
    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)
    At the time of study unblinding, after the required number of events
    are met, the participants will complete an EOT Visit and may continue
    into the LTFU Study A011-12 (SOTERIA).
    Al momento dell'apertura del cieco dello studio, dopo che il numero di eventi sarà stato raggiunto, i partecipanti completeranno la visita di EOT e potranno continuare nello studio di LTFU A011-12 (SOTERIA)
    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 Decision2021-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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