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    Summary
    EudraCT Number:2019-002101-21
    Sponsor's Protocol Code Number:ARGX-113-1803
    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:2021-06-17
    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 number2019-002101-21
    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) 10 mg/kg Intravenous 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) 10 mg/kg per via endovenosa in pazienti adulti con trombocitopenia immune primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder
    that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)
    Studio a lungo termine per valutare la sicurezza e l’efficacia di efgartigimod in pazienti adulti con trombocitopenia immune primaria (una malattia autoimmune che distrugge le piastrine, le cellule del sangue che favoriscono la coagulazione, e che può portare a facilità o eccessiva contusione o sanguinamento)
    A.3.2Name or abbreviated title of the trial where available
    ADVANCE+
    ADVANCE+
    A.4.1Sponsor's protocol code numberARGX-113-1803
    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 BVBA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationargenx BVBA
    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.5.5Fax number003293103499
    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
    D.3.2Product code [ARGX-113]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEfgartigimod
    D.3.9.1CAS number 1821402-21-4
    D.3.9.2Current sponsor codeARGX-113
    D.3.9.3Other descriptive nameARGX-113
    D.3.9.4EV Substance CodeSUB180001
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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
    Trombocitopenia immune primaria
    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
    Malattia che può portare a facile o eccessiva contusione e sanguinamento a causa dei bassi livelli di cellule che favoriscono la coagulazione del sangue
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10050245
    E.1.2Term Autoimmune 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 long-term safety of efgartigimod in adult patients with primary immune thrombocytopenia (ITP).
    Valutare la sicurezza a lungo termine di efgartigimod in pazienti adulti con trombocitopenia immune (ITP) primaria.
    E.2.2Secondary objectives of the trial
    • To evaluate the long-term efficacy of efgartigimod on overall platelet count response.
    • To explore the potential for reduction in concurrent ITP therapy.
    • To evaluate the effects of efgartigimod treatment on quality-of-life (QoL) measures and patient-reported outcomes (PRO).
    • To assess the pharmacodynamic (PD) effects of efgartigimod.
    • To evaluate the pharmacokinetics (PK) of efgartigimod.
    • To assess the immunogenicity of efgartigimod.
    • Valutare l’efficacia a lungo termine di efgartigimod sulla risposta complessiva in termini di conta piastrinica.
    • Esplorare la potenziale riduzione della terapia concomitante per l’ITP.
    • Valutare gli effetti del trattamento con efgartigimod sulle misurazioni della qualità della vita (QoL) e sugli esiti segnalati dal/la paziente (PRO).
    • Valutare gli effetti farmacodinamici (PD) di efgartigimod.
    • Valutare la farmacocinetica (PK) di efgartigimod.
    • Valutare l’immunogenicità di efgartigimod.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand the requirements 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).
    2. Patients enrolled in the ARGX-113-1801 trial who completed the 24- week trial period.
    3. Women of childbearing potential must have a negative urine pregnancy test at baseline before trial medication (infusion) can be administered. Women are considered of childbearing potential unless they are post-menopausal (defined by continuous amenorrhea) for at least 1 year with a FSH of >40 IU/L or are surgically sterilized (ie, women who had a hysterectomy, both ovaries surgically removed, or have a documented permanent female sterilization procedure including tubal ligation). Follicle-stimulating hormone can be used to confirm postmenopausal status in amenorrheic patients not on hormonal replacement therapy.
    4. Women of childbearing potential should use a highly effective method of contraception (ie, pregnancy rate of less than 1% per year) during the trial and for 90 days after the last administration of the IMP. They must be on a stable regimen, for at least 1 month:
    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
    - oral
    - intravaginal
    - transdermal
    • progestogen-only hormonal contraception associated with inhibition of ovulation:
    - oral
    - injectable
    - implantable
    • intrauterine device (IUD)
    • intrauterine hormone-releasing system
    • bilateral tubal occlusion
    • vasectomized partner(provided that the partner is the sole sexual partner of the trial participant and that aspermia was documented post procedure)
    • continuous abstinence from heterosexual sexual contact. Sexual abstinence is only allowable if it is the preferred and usual lifestyle of the patient. Periodic abstinence (calendar, symptothermal, postovulation methods) is not acceptable.
    5. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use effective double contraception, being a condom for male patients and a highly effective form of contraception for the female partner of childbearing potential (same as for female patients described in inclusion criterion 4). Male patients practicing true sexual abstinence (when this is in line with the preferred and usual lifestyle of the participant) can be included. Sterilized male patients who have had vasectomy with documented aspermia post procedure can be included. In addition, male patients are not allowed to donate sperm during this period from signing of informed consent form, throughout the duration of the trial, and for 90 days after the last administration of IMP.
    1. Capacità di comprendere i requisiti della sperimentazione, di fornire il consenso informato scritto (compreso il consenso ad usare e divulgare le informazioni sanitarie correlate alla ricerca), e a seguire le procedure del protocollo della sperimentazione (comprese le visite della sperimentazione richieste).
    2. Pazienti arruolati nello studio ARGX-113-1801 che hanno completato il periodo di sperimentazione di 24 settimane.
    3. Le donne potenzialmente fertili devono avere un test di gravidanza delle urine negativo al basale prima che possa essere somministrato il medicinale della sperimentazione (infusione). Le donne sono considerate potenzialmente fertile salvo che siano in menopausa (definita da amenorrea continua) da almeno 1 anno con un ormone follicolo-stimolante (FSH) >40 IU/L o che siano sterilizzate chirurgicamente (cioè donne che sono state sottoposte a isterectomia, rimozione chirurgica di entrambe le ovaie o che sono state sottoposte ad una procedura di sterilizzazione femminile permanente documentata, compresa la legatura delle tube). L’ormone follicolo-stimolante può essere usato per confermare lo stato post-menopausa in pazienti amenorreiche che non assumono la terapia ormonale sostitutiva.
    4. Le donne potenzialmente fertili devono usare un metodo contraccettivo altamente efficace (cioè con tasso di gravidanza di meno dell’1% all’anno) durante la sperimentazione e per 90 giorni dopo l’ultima somministrazione dell’IMP. Devono essere in regime stabile da almeno 1 mese:
    • contraccezione ormonale combinata (contenente estrogeno e progestinico) associata all’inibizione dell’ovulazione:
    o orale
    o intravaginale
    o transdermica
    • contraccezione ormonale a base di solo progestinico associata all’inibizione dell’ovulazione:
    o orale
    o iniettabile
    o impiantabile
    • dispositivo intrauterino (IUD)
    • sistema intrauterino a rilascio ormonale
    • occlusione bilaterale delle tube
    • partner vasectomizzato (purché il partner sia l’unico partner sessuale della partecipante alla sperimentazione e purché l’aspermia sia stata documentata dopo l’intervento)
    • astinenza continua dal contatto sessuale eterosessuale. L’astinenza sessuale è accettabile solo se corrisponde allo stile di vita preferito e abituale del/della paziente. L’astinenza periodica (metodi basati sul calendario, sintotermici, post-ovulazione) non è accettabile.
    5. I pazienti di sesso maschile non sterilizzati che sono sessualmente attivi con una partner potenzialmente fertile, devono usare un doppio metodo contraccettivo efficace, cioè un preservativo per il paziente di sesso maschile e un metodo contraccettivo altamente efficace per la partner potenzialmente fertile (stessi metodi descritti per le pazienti di sesso femminile nel criterio di inclusione 4). I soggetti di sesso maschile che praticano l’astinenza totale (quando ciò è conforme allo stile di vita preferito e abituale del partecipante) possono essere inclusi. Pazienti di sesso maschile che hanno avuto una vasectomia con aspermia documentata post-procedura, possono essere inclusi. Inoltre i pazienti di sesso maschile non devono donare sperma durante questo periodo, dalla firma del consenso informato, per tutta la durata della sperimentazione e per 90 giorni dopo l’ultima somministrazione di IMP.
    E.4Principal exclusion criteria
    1. Introduction or continuation of non-permitted medications during the ARGX-113-1801 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins or live/live-attenuated vaccines).
    2. Pregnant or lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing.
    3. Patients with known medical history of hypersensitivity to any of the ingredients of efgartigimod.
    4. Use of any other investigational drug or participation in any other investigational trial.
    1. Introduzione o continuazione di medicinali non permessi durante la sperimentazione ARGX 113 1801 (come la terapia anti-CD20, romiplostim, anticorpi monoclonali, proteine di fusione Fc o vaccini vivi/vivi-attenuati).
    2. Donne in gravidanza o che allattano con latte materno e quelle che programmano di iniziare una gravidanza durante la sperimentazione o entro 90 giorni dopo l’ultima somministrazione della dose.
    3. Pazienti con anamnesi clinica nota di ipersensibilità ad uno qualsiasi dei componenti di efgartigimod.
    4. Uso di un qualsiasi altro medicinale sperimentale o partecipazione a qualsiasi altra sperimentazione.
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and severity of AEs, vital signs, and laboratory assessments.
    Frequenza e gravità degli eventi avversi, parametri vitali, valutazioni di laboratorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Frequency and severity of AEs - at each visit
    Vital signs - at baseline visit (week 1), followed by every even week (week 2 to week 52) and Early discontinuation, follow-up 1 and 2,
    unscheduled visits.
    Laboratory assessments - please refer to protocol Table 1 Schedule of Assessments for various laboratory assessments
    Frequenza e gravità degli EA - a ciascuna visita
    Parametri vitali - alla visita basale (settimana 1) e, in seguito, ad ogni visita pari (dalla settimana 2 alla settimana 52) e alle visite di Interruzione anticipata, follow-up 1 e 2 e non programmate.
    Valutazioni di laboratorio- vedere Tabella 1 del protocollo, Programma delle valutazioni per le varie valutazioni di laboratorio
    E.5.2Secondary end point(s)
    1. Extent of disease control defined as the number of cumulative weeks over the planned 52-week treatment period with platelet counts of > and =
    50×10^9/L.
    2. Percentage 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-113-1801 trial with a platelet count of <30×10^9/L: time to response is defined as the time to achieve 2 consecutive platelet counts of > and =50×10^9/L.
    5. The number of cumulative weeks over the planned 52-week treatment period with platelet counts of > and =30×10^9/L and at least 20×10^9/L
    above baseline.
    6. In patients with baseline platelet count of <15×10^9/L in the current trial (ARGX-113-1803), the number of cumulative weeks over the
    planned 52-week treatment period with platelet counts of > and =30×10^9/L and at least 20×10^9/L above baseline.
    7. In patients with first exposure to efgartigimod: proportion of patients who achieve a sustained platelet response defined as achieving platelet counts of at least 50×10^9/L for at least 4 of the 6 visits between week 19 and 24 of the trial.
    8. In patients with first exposure to efgartigimod: proportion of patients in the overall population achieving platelet counts of at least 50×10^9/L for at least 6 of the 8 visits between week 17 and 24 of the trial.
    9. Rate of receipt of rescue therapy (rescue per patient per month).
    10. Reduction in concurrent ITP therapy.
    11. Incidence and severity of the WHO-classified bleeding events.
    12. Change from baseline in PRO (FACIT-Fatigue, Fact-Th6) and QoL (SF-36) at planned visits.
    13. Incidence of anti-drug antibodies (ADA) to efgartigimod.
    14.Pharmacokinetic parameters of efgartigimod:maximum observed serum concentration (C max) and serum concentration observed predose (Ctrough)
    15. Pharmacodynamics markers: total IgG, IgG isotypes (IgG1, IgG2, IgG3, IgG4).; 1. Grado di controllo della malattia definito come il numero cumulativo di settimane con conta piastrinica > e=50×109/L nel periodo di trattamento previsto di 52 settimane.
    2. Percentuale di pazienti con risposta complessiva in termini di conta piastrinica definita come il raggiungimento di una conta piastrinica > e =50×109/L in almeno 4 occasioni in qualsiasi momento nel periodo di trattamento di 52 settimane.
    3. Cambiamento medio dal basale nella conta piastrinica a ciascuna visita.
    4. Per i pazienti che passano dallo studio ARGX-113-1801 con una conta piastrinica <30×109/L: il tempo alla risposta è definito come il tempo per raggiungere 2 conte piastriniche consecutive di > e =50×109/L.
    5. Numero cumulativo di settimane con conta piastrinica > e =30×109/L e almeno 20×109/L sopra il basale nel periodo di trattamento previsto di 52 settimane.
    6. Nei pazienti con conta piastrinica <15×109/L nella sperimentazione attuale (ARGX-113-1803), numero cumulativo di settimane con conta piastrinica > e =30×109/L e almeno 20×109/L sopra il basale nel periodo di trattamento previsto di 52 settimane.
    7. In pazienti con prima esposizione a efgartigimod: proporzione di pazienti che raggiungono una risposta piastrinica sostenuta, definita come il raggiungimento di conte piastriniche di almeno 50×109/L per almeno 4 delle 6 visite tra la settimana 19 e la 24 della sperimentazione.
    8. In pazienti con prima esposizione a efgartigimod: proporzione di pazienti nella popolazione complessiva che raggiungono conte piastriniche di almeno 50×109/L per almeno 6 delle 8 visite tra la settimana 17 e la 24 della sperimentazione.
    9. Tasso di utilizzo della terapia di emergenza (emergenza per paziente per mese).
    10. Riduzione della terapia concomitante per l’ITP.
    11. Incidenza e gravità degli eventi di sanguinamento classificate in base a WHO.
    12. Cambiamento dal basale in PRO (FACIT-Affaticamento, Fact-Th6) e QoL (SF-36) alle visite programmate.
    13. Incidenza di anticorpi anti farmaco (ADA) contro efgartigimod.
    14.Parametri farmacocinetici di efgartigimod: massima concentrazione sierica osservata (Cmax) e concentrazione sierica osservata pre-dose (Cvalle)
    15. Marcatori di farmacodinamica: IgG totale, isotipi IgG (IgG1, IgG2, IgG3, IgG4).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Over the 52-week treatment period
    2. Over the 52-week treatment period
    3. At each visit
    4. At each visit
    5. Over the 52-week treatment period
    6. Over the 52-week treatment period
    7. Between week 19 and 24
    8. Between weeks 17 and 24
    9. At each visit
    10. At each visit
    11. At each visit
    12. PRO: Visit 1, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 47, 49, 52 of Treatment period, Early Discontinuation QoL: Visit 1, 9, 17, 25, 33, 41, 49, 52 of Treatment period, Early Discontinuation
    13. Visit 1, 5, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Treatment period, Early Discontinuation, Follow-up 2, Unscheduled Visit
    14 and 15. Visit 1, 5, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Treatment period, Early Discontinuation, Follow-up 1/2, Unscheduled Visit
    1.Durante trattamento di 52 sett, 2.Durante trattamento di 52 sett, 3.Ad ogni visita, 4.Ad ogni visita, 5.Durante trattamento di 52 settimane, 6.Durante trattamento di 52 sett, 7.Tra la sett.19 e 24, 8.Tra le sett. 17 e 24, 9.Ad ogni visita, 10.Ad ogni visita, 11.Ad ogni visita, 12.PRO: Visita 1, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 47, 49, 52 del Per. di tratt., Interruz anticipata QoL: Visita 1, 9, 17, 25, 33, 41, 49, 52 del Periodo di trattamento, Interruz anticipata, 13.Visita 1, 5, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, del Periodo di trattamento, Interruzione anticipata, Follow-up 2, Visita non programmata, 14 e 15.Visita 1, 5, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, del Periodo di trattamento, Interruzione anticipata, Follow-up 1/2, Visita non programmata
    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 of efgartigimod
    Immunogenicità di efgartigimod
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Georgia
    Japan
    Russian Federation
    Turkey
    United States
    Austria
    Belgium
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    Czechia
    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 years2
    E.8.9.1In the Member State concerned months0
    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 months0
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    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 patient has completed the trial or has withdrawn/discontinued early, usual treatment will be administered if required, in accordance with the trial sites' standard of care and generally accepted medical practice depending on the patient's individual needs.
    Dopo che un paziente ha completato la sperimentazione o si è ritirato/ha interrotto anticipatamente, il trattamento abituale sarà somministrato, se necessario, in conformità allo standard di cura del centro della sperimentazione e alla pratica clinica generalmente accettata, in base alle necessità individuali del/la paziente.
    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 Decision2020-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-18
    P. End of Trial
    P.End of Trial StatusOngoing
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