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    Summary
    EudraCT Number:2020-004033-20
    Sponsor's Protocol Code Number:ARGX-113-2005
    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:2021-08-17
    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 number2020-004033-20
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
    Sperimentazione di fase 3, multicentrica, in aperto, a lungo termine per valutare la sicurezza e l’efficacia di efgartigimod (ARGX 113) PH20 per via sottocutanea in pazienti adulti con trombocitopenia immune primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
    Studio per valutare la sicurezza e l’efficacia di Efgartigimod (ARGX-113) PH20 con somministrazione sottocutanea in pazienti adulti affetti da trombocitopenia immune primaria
    A.3.2Name or abbreviated title of the trial where available
    ADVANCE SC+
    ADVANCE SC+
    A.4.1Sponsor's protocol code numberARGX-113-2005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04812925
    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 SponsorARGENX BV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportargenx BV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationargenx BV
    B.5.2Functional name of contact pointRegulatory
    B.5.3 Address:
    B.5.3.1Street AddressIndustriepark Zwijnaarde 7
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post codeB-9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number003293103400
    B.5.6E-mailregulatory@argenx.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/3/19/2230
    D.3 Description of the IMP
    D.3.1Product nameefgartigimod PH20 SC
    D.3.2Product code [ARGX-113]
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNefgartigimod alfa
    D.3.9.1CAS number 1821402-21-4
    D.3.9.2Current sponsor codeARGX-113
    D.3.9.4EV Substance CodeSUB198780
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary immune thrombocytopenia (ITP)
    Trombocitopenia immune primaria (ITP)
    E.1.1.1Medical condition in easily understood language
    Disorder that can lead to easy or excessive bruising and bleeding due to low levels of the cells that help blood clot
    Disturbo che può causare facile comparsa di ecchimosi ed eccessivo sanguinamento dovuti ai bassi livelli di cellule che aiutano la coagulazione del sangue
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10083843
    E.1.2Term Primary immune thrombocytopenia
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of efgartigimod PH20 SC in adult patients with primary ITP
    Valutare la sicurezza e la tollerabilità di efgartigimod PH20 SC in pazienti adulti affetti da ITP primaria
    E.2.2Secondary objectives of the trial
    First 52-week treatment period only
    • To evaluate the efficacy of efgartigimod PH20 SC on overall platelet count response
    • To evaluate the use of rescue treatment and reduction in concurrent ITP therapy while receiving treatment with efgartigimod PH20 SC
    • To evaluate the incidence and severity of bleeding events while receiving treatment with efgartigimod PH20 SC
    • To assess the PK of efgartigimod PH20 SC
    • To evaluate the effects of efgartigimod PH20 SC treatment on quality-of-life (QoL) measures and patient-reported outcomes (PRO)
    • To assess the PD effects of efgartigimod PH20 SC
    • To evaluate the feasibility of self-administration of efgartigimod PH20 SC

    First 52-week treatment period and additional 52-week treatment
    periods
    • To assess the immunogenicity of efgartigimod and/or rHuPH20
    Solo nel primo periodo di trattamento di 52 settimane
    • Valutare l’efficacia di efgartigimod PH20 SC sulla risposta della conta piastrinica complessiva
    • Valutare l’utilizzo del trattamento di soccorso e la riduzione della terapia ITP concomitante durante il ricevimento del trattamento con efgartigimod PH20 SC
    • Valutare l’incidenza e la gravità degli eventi di sanguinamento durante il ricevimento del trattamento con efgartigimod PH20 SC
    • Valutare la PK di efgartigimod PH20 SC
    • Valutare gli effetti del trattamento con efgartigimod PH20 SC sulle misure della qualità della vita (QoL) e gli esiti riferiti dai pazienti (PRO)
    • Valutare gli effetti PD di efgartigimod PH20 SC
    • Valutare la fattibilità dell’auto-somministrazione di efgartigimod PH20 SC

    Primo periodo di trattamento di 52 settimane e periodi di trattamento di 52 settimane aggiuntivi
    • Valutare l’immunogenicità di efgartigimod e/o rHuPH20
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the trial only if all of the following criteria apply:
    1. Ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits).
    2. Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period. Note: If a participant has had an SAE during the ARGX-113-2004 trial, his/her eligibility should be evaluated by the investigator and the sponsor's trial physician. The decision of enrolling the participant will be evaluated case by case.
    3. Women of childbearing potential:
    • As defined in Woman of Childbearing Potential in the protocol, women of childbearing potential must have a negative urine pregnancy test at baseline before trial medication can be administered
    • Must be on a stable regimen for at least 1 month of a highly effective or acceptable method of contraception (see Female Contraception in the protocol) during the trial and for 90 days after the last administration of efgartigimod PH20 SC
    4. Non-sterilized male participants who are sexually active with a female partner of childbearing potential must use an acceptable method of contraception, ie, a condom (see Male Contraception in the protocol) from signing the informed consent form (ICF) until the end of the trial. Male participants are not allowed to donate sperm from signing the ICF until the end of the trial.
    In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period (only applicable in case efgartigimod is not yet commercially available for patients with primary ITP or available through another patient program for patients with primary ITP):
    5. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).
    6. Participant has completed a 52-week treatment period.
    I partecipanti sono idonei all’inclusione nello studio solo se si applicano tutti i seguenti criteri:
    1. capacità di comprendere i requisiti dello studio e di fornire il consenso informato scritto (incluso il consenso per l’utilizzo e la divulgazione delle informazioni sanitarie correlate alla ricerca), disponibilità e capacità di rispettare le procedure del protocollo dello studio (incluso presentarsi alle visite dello studio obbligatorie);
    2. partecipanti arruolati nello studio ARGX-113-2004 che hanno completato il periodo dello studio di 24 settimane. Nota: se un/una partecipante ha manifestato un SAE durante lo studio ARGX-113-2004, la sua idoneità dovrà essere rivalutata dallo sperimentatore e dal medico dello studio dello sponsor. La decisione relativa all’arruolamento dei partecipanti sarà valutata caso per caso.
    3. Donne in età fertile:
    • come definito nella sezione Donne potenzialmente fertili del protocollo, le donne in età fertile devono avere un test di gravidanza delle urine negativo al basale prima di procedere alla somministrazione del farmaco sperimentale;
    • devono seguire un regime stabile da almeno 1 mese con un metodo contraccettivo altamente efficace o accettabile (vedere la sezione Contraccezione femminile nel protocollo) durante lo studio e per 90 giorni dopo l’ultima somministrazione di efgartigimod PH20 SC;
    4. I partecipanti di sesso maschile non sterilizzati che sono sessualmente attivi con una partner femminile in età fertile devono utilizzare un metodo contraccettivo accettabile, ossia un profilattico (vedere la sezione Contraccezione maschile nel protocollo) dalla firma del modulo di consenso informato (ICF) fino alla fine dello studio. I partecipanti di sesso maschile non sono autorizzati a donare lo sperma dalla firma dell’ICF fino alla fine dello studio.
    Oltre ai criteri anzidetti, per i partecipanti che vogliono continuare a ricevere efgartigimod durante un periodo di trattamento di 52 settimane aggiuntivo (applicabile solo nel caso in cui efgartigimod non sia ancora disponibile in commercio per i pazienti affetti da ITP primaria o disponibile tramite un altro programma per pazienti affetti da ITP primaria):
    5. capacità di comprendere i requisiti del periodo di trattamento di 52 settimane aggiuntivo dello studio, di fornire il consenso informato scritto (incluso il consenso per l’utilizzo e la divulgazione delle informazioni sanitarie correlate alla ricerca) e di rispettare le procedure del protocollo dello studio (incluse le visite dello studio obbligatorie);
    6. il/la partecipante ha completato un periodo di trattamento di 52 settimane.
    E.4Principal exclusion criteria
    Participants are eligible to be included in the trial only if none of the following criteria apply:
    1. Introduction or continuation of nonpermitted medications during the ARGX-113-2004 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins, or live/live-attenuated vaccines)
    2. Use of any other investigational drug or participation in any other investigational trial
    3. Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients
    4. Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC
    I partecipanti sono idonei all’inclusione nello studio solo se non si applica nessuno dei seguenti criteri:
    1. introduzione o continuazione dei farmaci non consentiti durante lo studio ARGX-113-2004 (come terapia anti-CD20, romiplostim, anticorpi monoclonali, proteine di fusione Fc o vaccini vivi/attenuati vivi);
    2. utilizzo di qualsiasi altro farmaco sperimentale o partecipazione ad altri studi sperimentali;
    3. nota reazione da ipersensibilità a efgartigimod PH20 SC o a uno qualsiasi dei suoi eccipienti;
    4. donne in gravidanza o che allattano al seno e donne che intendono iniziare una gravidanza durante lo studio o entro 90 giorni dall’ultima dose di efgartigimod PH20 SC.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence, frequency, and severity of adverse events (AEs), AEs of special interest (AESIs), and serious AEs (SAEs)
    2. Vital signs, electrocardiogram (ECG), and laboratory safety evaluations
    1. Incidenza, frequenza e gravità degli eventi avversi (AE), AE di speciale interesse (AESI) e AE gravi (SAE)
    2. Parametri vitali, elettrocardiogramma (ECG) e valutazioni di laboratorio sulla sicurezza
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At all visits
    2. At planned visits per schedule of assessment
    1. Durante tutte le visite
    2. Durante le visite programmate secondo il calendario delle valutazioni
    E.5.2Secondary end point(s)
    First 52-week treatment period only
    1. Extent of disease control defined as the percentage of weeks in the trial with platelet counts of > and =50×10^9/L
    2. Proportion of patients with overall platelet count response defined as achieving a platelet count of > and =50×10^9/L on at least 4 occasions at any time during the 52-week treatment period
    3. Mean change from baseline in platelet count at each visit
    4. For patients rolling over from the ARGX-113-2004 trial with a platelet count of <30×10^9/L: time to response defined as the time to achieve 2 consecutive platelet counts of > and =50×10^9/L
    5. The percentage of weeks in the trial with platelet counts of > and = 30×10^9/L and > and =20×10^9/L above baseline
    6. In patients with a baseline platelet count of <15×10^9/L in the current trial (ARGX-113-2005), the percentage of weeks in the trial with platelet counts of > and =30×10^9/L and > and =20×10^9/L above baseline
    7. In patients with the first exposure to efgartigimod PH20 SC, the proportion of patients who achieve a sustained platelet response defined as achieving platelet counts of > and =50×10^9/L for at least 4 of the 6 visits between week 19 and week 24
    8. In patients with the first exposure to efgartigimod PH20 SC, the proportion of patients achieving platelet counts of > and =50×10^9/L for at least 6 of the 8 visits between week 17 and week 24
    9. Proportion of patients for whom dose and/or frequency of concurrent ITP therapies have been reduced compared to baseline
    10. Rate of receipt of rescue therapy (rescue per patient per month)
    11. Incidence and severity of the World Health Organization (WHO)- classified bleeding events
    12. Serum efgartigimod concentration observed predose (Ctrough)
    13. Change from baseline in PRO (Functional Assessment of Chronic Illness Therapy Fatigue Scale [FACIT-fatigue], Functional Assessment of Cancer Therapy questionnaire-Th6 [FACT-Th6]) and QoL (Short Form-36 [SF-36]) at planned visits
    14. Pharmacodynamics markers: total IgG
    15. Number and percentage of patients who performed self-administration at home over time
    16. Number and percentage of caregivers who administered the injection to the patient at home over time
    17. Number of training visits needed for the participant or caregiver to be competent to start administering efgartigimod PH20 SC
    18. Number and percentage of self- or caregiver-supported administrations at home

    First 52-week treatment period and additional 52-week treatment periods
    19. Incidence and prevalence of antibodies to efgartigimod
    20. Titers of antibodies to efgartigimod
    21 Presence of neutralizing antibodies (NAb) against efgartigimod
    Solo il primo periodo di trattamento di 52 settimane
    1. Grado di controllo della malattia definito come la percentuale di settimane nello studio con conte piastriniche di > e = 50×10^9/l
    2. Proporzione di pazienti con risposta della conta piastrinica complessiva definita come il raggiungimento di una conta piastrinica > e =50×10^9/l in almeno 4 occasioni in qualsiasi momento durante il periodo di trattamento di 52 settimane
    3. Cambiamento medio dal basale nella conta piastrinica durante ogni visita
    4. Per i pazienti che effettuano il passaggio dallo studio ARGX-113-2004 con una conta piastrinica di <30×10^9/l: tempo alla risposta definito come periodo necessario per ottenere 2 conte piastriniche consecutive di > e =50×10^9/l
    5. La percentuale di settimane nello studio con conte piastriniche di > e =30×10^9/l e > e =20×10^9/l al di sopra del basale
    6. Nei pazienti con una conta piastrinica basale di <15×10^9/l nello studio attuale (ARGX-113-2005), la percentuale di settimane nello studio con conte piastriniche di > e =30×10^9/l e > e =20×10^9/l al di sopra del basale
    7. Nei pazienti con prima esposizione a efgartigimod PH20 SC, la proporzione di pazienti che ottiene una risposta piastrinica sostenuta definita come il raggiungimento di conte piastriniche di > e =50×10^9/l per almeno 4 delle 6 visite tra la settimana 19 e la settimana 24
    8. Nei pazienti con prima esposizione a efgartigimod PH20 SC, la proporzione di pazienti che ottiene conte piastriniche di > e =50×10^9/l per almeno 6 delle 8 visite tra la settimana 17 e la settimana 24
    9. Proporzione di pazienti per cui la dose e/o la frequenza delle terapie ITP concomitanti sono state ridotte rispetto al basale
    10. Tasso di ricevimento della terapia di soccorso (soccorso per paziente al mese)
    11. Incidenza e gravità degli eventi di sanguinamento classificati secondo l’Organizzazione Mondiale della Sanità (OMS)
    12. Concentrazione di efgartigimod osservata nel siero prima della dose (Ctrough)
    13. Variazione dal basale nei punteggi PRO (Functional Assessment of Chronic Illness Therapy Fatigue Scale [FACIT-fatigue], Functional Assessment of Cancer Therapy questionnaire-Th6 [FACT-Th6]) e QoL (Forma breve-36 [SF-36]) alle visite programmate
    14. Marcatori di farmacodinamica: IgG totale
    15. Numero e percentuale di pazienti che hanno eseguito l’auto-somministrazione a casa nel tempo
    16. Numero e percentuale di caregiver che hanno somministrato l’iniezione al/alla paziente a casa nel tempo
    17. Numero di visite formative necessarie per il/la partecipante o il caregiver per acquisire la competenza richiesta per iniziare la somministrazione di efgartigimod PH20 SC
    18. Numero e percentuale di auto-somministrazioni o somministrazioni effettuate dal caregiver a casa

    Primo periodo di trattamento di 52 settimane e periodi di trattamento di 52 settimane aggiuntivi
    19. Incidenza e prevalenza di anticorpi contro efgartigimod
    20. Titoli degli anticorpi contro efgartigimod
    21. Presenza di anticorpi neutralizzanti (Nab) contro efgartigimod
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2 At any time during the 52-week treatment period
    3. At each visit
    4, 5, 6 At planned visits per schedule of assessment
    7. Between week 19 and week 24
    8. Between week 17 and week 24
    9,10,11,12, 13, 14 At planned visits per schedule of assessment
    15, 16, 17, 18 Throughout the treatment period
    19, 20, 21 At planned visits per schedule of assessments
    1, 2 In qualunque momento durante il periodo di trattamento di 52 settimane
    3. Durante ogni visita
    4, 5, 6 Durante le visite programmate secondo il calendario delle valutazioni
    7. Tra la settimana 19 e la settimana 24
    8. Tra la settimana 17 e la settimana 24
    9, 10, 11, 12, 13, 14 Durante le visite programmate secondo il calendario delle valutazioni
    15, 16, 17, 18 Per tutto il periodo di trattamento
    19, 20, 21 Durante le visite programmate secondo il calendario delle valutazioni
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    immonogenicita'
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    non applicabile
    not applicable
    E.8.2.4Number of treatment arms in the trial1
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Chile
    China
    Colombia
    Georgia
    Israel
    Japan
    Jordan
    Korea, Republic of
    Mexico
    New Zealand
    Peru
    Russian Federation
    Serbia
    South Africa
    Taiwan
    Thailand
    Tunisia
    Turkey
    United States
    Bulgaria
    Denmark
    France
    Germany
    Ireland
    Italy
    Latvia
    Norway
    Poland
    Portugal
    Romania
    Spain
    United Kingdom
    Argentina
    Greece
    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
    LPLV
    ultimo paziente ultima visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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: 136
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 156
    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)
    After a participant has completed the trial, has withdrawn/discontinued early, or has completed the 2 follow-up visits, usual treatment will be administered if required, in accordance with the trial site's standard of care and generally accepted medical practice depending on the participant's individual needs.
    Dopo che un/una partecipante ha completato lo studio, si è ritirato/a o ha interrotto lo studio anticipatamente oppure ha completato le 2 visite di follow-up, se necessario sarà somministrato il trattamento abituale, in conformità con lo standard di cura del centro sperimentale e la prassi medica generalmente accettata a seconda delle esigenze individuali del/della partecipante.
    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 Decision2021-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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