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    Summary
    EudraCT Number:2019-000465-20
    Sponsor's Protocol Code Number:NN7769-4513
    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:2021-06-15
    Trial results View 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 number2019-000465-20
    A.3Full title of the trial
    Safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple subcutaneous doses of NNC0365-3769 (Mim8) in healthy subjects and in subjects with haemophilia A with or without factor VIII inhibitors
    Sicurezza, tollerabilità, farmacocinetica e farmacodinamica di una dose singola e di dosi multiple di NNC0365-3769 (Mim8) in somministrazione sottocutanea in soggetti sani e in soggetti con emofilia A, in presenza o in assenza di inibitori del fattore VIII
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study investigating Mim8 in people with haemophilia A
    Uno studio clinico di ricerca su Mim8 in persone con emofilia A
    A.3.2Name or abbreviated title of the trial where available
    FRONTIER1
    FRONTIER1
    A.4.1Sponsor's protocol code numberNN7769-4513
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1227-4220
    A.5.4Other Identifiers
    Name:FRONTIER1Number:NN7769-4513
    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 SponsorNOVO NORDISK. S.P.A.
    B.1.3.4CountryItaly
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointClinical Disclosure (1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo Allé
    B.5.3.2Town/ cityBagsværd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.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 nameNNC0365-3769 A 10 mg/mL
    D.3.2Product code [NNC0365-3769 A 10 mg/mL]
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeNNC0365-3769
    D.3.9.3Other descriptive nameNNC0365-3769
    D.3.9.4EV Substance CodeSUB198393
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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.IMP: 2
    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 nameNNC0365-3769 A 100 mg/mL
    D.3.2Product code [NNC0365-3769 A 100 mg/mL]
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeNNC0365-3769
    D.3.9.3Other descriptive nameNNC0365-3769
    D.3.9.4EV Substance CodeSUB198393
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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
    Healthy volunteers (Haemophilia A with or without inhibitors)
    Haemophilia A
    Haemophilia A with inhibitors
    Volontari sani (emofilia A con o senza inibitori)
    Emofilia A
    Emofilia A con inibitori
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers
    Bleeding disorder inherited deficiency in clotting factor VIII
    Bleeding disorder inherited deficiency in clotting factor VIII with
    antibodies to clotting factor replacement therapy
    Volontari sani
    Disturbi della coagulazione (carenza del fattore VIII)
    Disturbi della coagulazione (carenza del fattore VIII) con anticorpi contro la terapia sostitutiva del fattore di coagulazione
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10053751
    E.1.2Term Hemophilia A with anti factor VIII
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018938
    E.1.2Term Haemophilia A (Factor VIII)
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety and tolerability of subcutaneous Mim8 in healthy subjects and in subjects with severe haemophilia A with or without FVIII inhibitors
    Studiare la sicurezza e la tollerabilità di Mim8 in somministrazione sottocutanea in soggetti sani e in soggetti con emofilia A grave con o senza inibitori del FVIII
    E.2.2Secondary objectives of the trial
    1. To investigate the pharmacokinetics of subcutaneous Mim8 in healthy subjects and in subjects with severe haemophilia A with or without FVIII inhibitors
    2. To investigate the pharmacodynamics of subcutaneous Mim8 in healthy subjects and in subjects with severe haemophilia A with or without FVIII inhibitors
    1. Studiare la farmacocinetica di Mim8 n somministrazione sottocutanea in soggetti sani e in soggetti con emofilia grave A con o senza inibitori del FVIII
    2. Studiare la farmacodinamica di Mim8 n somministrazione sottocutanea in soggetti sani e in soggetti con emofilia A grave con o senza inibitori del FVIII
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Single ascending dose (SAD) part:
    - Male, aged 18-45 years (both inclusive) at the time of signing informed consent
    - Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

    Multiple ascending dose (MAD) part:
    - Male, aged 12-64 years (both inclusive) at the time of signing informed consent (Germany and Japan have local requirements)
    - Diagnosis of congenital haemophilia A with FVIII activity <1% based on medical records

    Exploratory biomarker cohort:
    - Male, aged =12 years at the time of signing informed consent (Germany and Japan have local requirements)
    - Diagnosis of congenital haemophilia A with FVIII activity <1% based on medical records
    Parte SAD dose singola crescente (fase 1, prevista solo in Germania):
    - Soggetti di sesso maschile di età tra 18 e 45 anni (entrambi compresi) al momento della firma del modulo di consenso informato
    - Soggetti considerati generalmente sani sulla base dell'anamnesi, esame fisico, risultati di segni vitali, elettrocardiogramma e test clinici di laboratorio eseguiti durante la visita di screening, in base al giudizio del medico dello studio

    Parte MAD dosi multiple ascendenti (fase 2, multinazionale, prevista in Italia):
    - Soggetti di sesso maschile di età tra 12-64 anni (estremi compresi) al momento della firma del modulo di consenso informato.
    - Diagnosi di emofilia A congenita con attività di FVIII <1% sulla base delle cartelle cliniche

    Coorte biomarcatori esplorativi (fase 2 multinazionale, prevista in Italia):
    - Soggetti di sesso maschile, età =12 anni al momento della firma del modulo di consenso informato.
    - Diagnosi di emofilia A congenita con attività di FVIII <1% sulla base delle cartelle cliniche
    E.4Principal exclusion criteria
    SAD part:
    - Factor VIII activity =150% at screening
    - Increased risk of thrombosis, e.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis
    - Any clinical signs or established diagnosis of venous or arterial thromboembolic disease

    MAD part:
    - Known congenital or acquired coagulation disorders other than haemophilia A
    - Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
    - Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
    - Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator
    - Any autoimmune disease that may increase the risk of thrombosis
    - Receipt of emicizumab or drugs with similar modes of action within 5 half-lives before trial product administration
    - Ongoing or planned immune tolerance induction therapy

    Exploratory biomarker cohort:
    - Known congenital or acquired coagulation disorders other than haemophilia A
    - Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
    - Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
    - Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator
    - Any autoimmune disease that may increase the risk of thrombosis
    - Ongoing or planned immune tolerance induction therapy
    Parte SAD (fase 1, prevista solo in Germania):
    - Attività del fattore VIII =150% allo screening
    - Rischio di trombosi aumentato, ad es. nota anamnesi personale o di uno o più parenti di primo grado di trombosi venosa profonda non indotta
    - Qualsiasi segno clinico o diagnosi accertata di malattia tromboembolica venosa o arteriosa

    Parte MAD (fase 2, multinazionale, prevista in Italia):
    - Disturbi noti della coagulazione congeniti o acquisiti diversi dall’emofilia A
    - Rischio di trombosi aumentato a giudizio dello sperimentatore, ad es. nota anamnesi personale o di uno o più parenti di primo grado di trombosi venosa profonda non indotta ad eccezione di precedenti eventi trombotici associati all'uso del catetere per cui non è attualmente in corso un trattamento anti-trombotico.
    - Qualsiasi segno clinico o diagnosi conclamata di malattia tromboembolica venosa o arteriosa ad eccezione di precedenti eventi trombotici associati all'uso del catetere per cui non è attualmente in corso un trattamento anti-trombotico.
    - Malattia aterosclerotica in stadio avanzato (ad es. anamnesi nota di cardiopatia ischemica, ictus ischemico) a giudizio dello sperimentatore
    - Qualsiasi malattia autoimmune che possa aumentare il rischio di trombosi
    - Assunzione di emicizumab o farmaci con modalità d’azione simili entro 5 emivite dalla somministrazione del prodotto sperimentale
    - Terapia di induzione della tolleranza immunologica in corso o programmata

    Coorte dei biomarcatori esplorativi (fase 2 multinazionale, prevista in Italia):
    - Disturbi noti della coagulazione congeniti o acquisiti diversi dall’emofilia A
    - Aumentato rischio di trombosi a giudizio dello sperimentatore, ad es. nota anamnesi personale o di uno o più parenti di primo grado di trombosi venosa profonda non indotta ad eccezione di precedenti eventi trombotici associati all'uso del catetere per cui non è attualmente in corso un trattamento anti-trombotico.
    - Qualsiasi segno clinico o diagnosi conclamata di malattia tromboembolica venosa o arteriosa ad eccezione di precedenti eventi trombotici associati all'uso del catetere per cui non è attualmente in corso un trattamento anti-trombotico.
    - Malattia aterosclerotica in stadio avanzato (ad es. anamnesi nota di cardiopatia ischemica, ictus ischemico) a giudizio dello sperimentatore
    - Qualsiasi malattia autoimmune che possa aumentare il rischio di trombosi
    - Terapia di induzione della tolleranza immunologica in corso o programmata
    E.5 End points
    E.5.1Primary end point(s)
    1. Single ascending dose (SAD) part: Number of treatment emergent adverse events
    2. Multiple ascending dose (MAD) part: Number of treatment emergent adverse events
    3. Extensíon to the MAD part: Number of treatment emergent adverse events
    1. Parte a dose singola crescente (SAD): Numero di eventi avversi emergenti dal trattamento
    2. Parte a dosi multiple crescenti (MAD): Numero di eventi avversi emergenti dal trattamento
    3. Estensione della parte a dosi multiple crescenti (MAD)dello studio: Numero di eventi avversi emergenti dal trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From time of dosing (Day 1) to Week 16
    2. From time of first dosing (Day 1) to Week 12
    3. From Week 12 up to Week 120 (16 weeks after last dose)
    1. Dal momento della somministrazione (Giorno 1) alla Settimana 16
    2. Dal momento della prima somministrazione (Giorno 1) alla Settimana 12
    3. Dalla settimana 12 fino alla settimana 120 (16 settimane dopo l'ultima somministrazione)
    E.5.2Secondary end point(s)
    SAD part:
    1. Number of injection site reactions
    2. Relative change in D-dimer
    3. Relative change in prothrombin fragment 1 and 2
    4. Relative change in fibrinogen
    5. Relative change in platelets
    6. Cmax, SD: the maximum concentration of Mim8 after a single dose
    7. AUC0-inf, SD: the area under the Mim8 concentration-time curve from
    time 0 to infinity after a single dose
    8. t1/2, SD: the terminal half-life of Mim8 after a single dose
    9. tmax, SD: the time to maximum concentration of Mim8 after a single
    dose
    10. Change in activated partial thromboplastin time
    MAD part (weekly and monthly dosing):
    11. Number of injection site reactions
    12. Occurrence of anti-Mim8 antibodies
    13. Relative change in D-dimer
    14. Relative change in prothrombin fragment 1 and 2
    15. Relative change in fibrinogen
    16. Relative change in platelets
    MAD part, PK session 2 (weekly dosing):
    17. Cmax, MD: the maximum concentration of Mim8 after multiple doses
    18. AUCt, MD: the area under the Mim8 concentration-time curve in the
    dosing interval after multiple doses
    MAD part, PK session 2 (monthly dosing):
    19. Cmax, MD: the maximum concentration of Mim8 after multiple doses
    20. AUCt, MD: the area under the Mim8 concentration-time curve in the
    dosing interval after multiple doses
    MAD part (weekly dosing):
    21. Mean of maximum thrombin generation (peak height)
    MAD part (monthly dosing):
    22. Mean of maximum thrombin generation (peak height)
    23. Number of injection site reactions
    24. Occurrence of anti-Mim8 antibodies
    Parte SAD dose singola crescente (fase 1, prevista solo in Germania):
    1. Numero di reazioni a livello del sito di iniezione
    2. Variazione relativa nel D-dimero
    3. Variazione relativa nei frammenti protrombinici 1 e 2
    4. Variazione relativa nel fibrinogeno
    5. Variazione relativa nelle piastrine
    6. Cmax, SD: la concentrazione massima di Mim8 dopo una singola dose
    7. AUC0-inf, SD: l’area sotto la curva della concentrazione di Mim8 rispetto al tempo nell’intervallo di dosaggio dopo una singola dose
    8. t1/2, SD: emivita terminale di Mim8 dopo una singola dose
    9. tmax, SD: la concentrazione massima di Mim8 dopo una singola dose
    10. Variazione del tempo di tromboplastina parziale attivata

    Parte MAD dosi multiple ascendenti (fase 2, multinazionale, prevista in Italia):
    11. Numero di reazioni a livello del sito di iniezione
    12. Insorgenza di anticorpi anti-Mim8
    13. Variazione relativa nel D-dimero
    14. Variazione relativa nei frammenti protrombinici 1 e 2
    15. Variazione relativa nel fibrinogeno
    16. Variazione relativa nelle piastrine
    Parte MAD, sessione PK 2 (dosaggio settimanale)
    17. Cmax, MD: la concentrazione massima di Mim8 dopo dosi multiple
    18. AUCt, MD: l’area sotto la curva della concentrazione di Mim8 rispetto al tempo nell’intervallo di dosaggio dopo dosi multiple
    Parte MAD, sessione PK 2 (dosaggio mensile)
    19. Cmax, MD: la concentrazione massima di Mim8 dopo dosi multiple
    20. AUCt, MD: l’area sotto la curva della concentrazione di Mim8 rispetto al tempo nell’intervallo di dosaggio dopo dosi multiple
    Parte MAD (dosaggio settimanale)
    21. Media della generazione massima di trombina (altezza di picco)
    Parte MAD (dosaggio mensile)
    22. Media della generazione massima di trombina (altezza di picco)
    23 Numero di reazioni al sito di iniezione
    24. Sviluppo di anticorpi anti-Mim8
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From time of dosing (Day 1) to Week 16
    2-10. From baseline (Day 1) to Week 16
    11. From time of first dosing (Day 1) to Week 12
    12-16. From baseline (Day 1) to Week 12
    17-18. From Day 57 to Day 64
    19-20. From Day 57 to Day 85
    21. From Day 57 to Day 64
    22. From Day 57 to Day 85
    23-24. From Week 12 up to Week 120 (16 weeks after last dose)
    1. Dal momento della somministrazione (Giorno 1) alla Settimana 16
    2-10. Dal basale (Giorno 1) alla Settimana 16
    11. Dal momento della prima somministrazione (Giorno 1) alla Settimana 12
    12-16. Dal basale (Giorno 1) alla Settimana 12
    17-18. Dal Giorno 57 al Giorno 64
    19-20. Dal Giorno 57 al Giorno 85
    21. Dal Giorno 57 al Giorno 64
    22. Dal Giorno 57 al Giorno 85
    23-24. Dalla settimana 12 alla settimana 120 (16 settimane dopo l'ultima somministrazione)
    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 No
    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
    Tolerability and exploratory efficacy
    Tollerabilità ed efficacia esplorativa
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    parte SAD (fase 1) controllata con placebo in doppio cieco in coorti (prevista solo in Germania)- pa
    SAD part phase 1 placebo-controlled double-blind within cohorts - MAD part phase 2 open-label - ext.
    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 EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Japan
    Serbia
    South Africa
    Turkey
    United States
    Switzerland
    European Union
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 82
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    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 Decision2020-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-18
    P. End of Trial
    P.End of Trial StatusOngoing
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