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    Summary
    EudraCT Number:2020-003371-18
    Sponsor's Protocol Code Number:MAA-202
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 number2020-003371-18
    A.3Full title of the trial
    Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Marzeptacog alfa (activated) in Treatment of Episodic Bleeding in Subjects with Inherited Bleeding Disorders
    Studio di fase 1/2 per valutare farmacocinetica, farmacodinamica, sicurezza ed efficacia di Marzeptacog alfa (attivato) nel trattamento degli episodi emorragici in soggetti con coagulopatie ereditarie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Marzeptacog alfa (activated) in Treatment of Episodic Bleeding in Subjects with Factor VII deficiency, Glanzmann thrombasthenia, and Haemophilia A with inhibitors on prophylaxis
    Studio per valutare farmacocinetica, farmacodinamica, sicurezza ed efficacia di marzeptacog alfa (attivato) nel trattamento degli episodi emorragici in soggetti con il deficit di fattore VII, tromboastenia di Glanzmann o l’emofilia A con inibitori attualmente in trattamento preventivo con una dose di emicizumab.
    A.3.2Name or abbreviated title of the trial where available
    MAA-202
    MAA-202
    A.4.1Sponsor's protocol code numberMAA-202
    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 SponsorCatalyst Biosciences, 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 supportCatalyst Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCatalyst Biosciences, Inc.
    B.5.2Functional name of contact pointLinda Neuman, MD
    B.5.3 Address:
    B.5.3.1Street Address611 Gateway Blvd., Suite 710
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016502668667
    B.5.6E-maillneuman@catbio.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 nameMarzeptacog alfa (activated)
    D.3.2Product code [MarzAA, CB813d, PF-05280602]
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMarzeptacog alfa (activated)
    D.3.9.1CAS number 1600492-21-4
    D.3.9.2Current sponsor codeMarzAA, CB813d, PF-0528602
    D.3.9.4EV Substance CodeSUB192389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Factor VII deficiency, Glanzmann thrombasthenia (GT) and Hemophilia A with inhibitors on emicizumab prophylaxis (HAwI-E)
    deficit di fattore VII, tromboastenia di Glanzmann (GT) e l’emofilia A con inibitori attualmente in trattamento preventivo con una dose di emicizumab (HAwI-E).
    E.1.1.1Medical condition in easily understood language
    Inherited rare bleeding disorders in which blood cannot clot normally
    difetti ereditari della coagulazioni in cui il sangue non è in grado di coagulare normalmente
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10060612
    E.1.2Term Hemophilia A
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016079
    E.1.2Term Factor VII deficiency
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1 by Cohort
    • To evaluate the PK of ascending SC doses of MarzAA and confirm the Phase 2 dose
    Phase 2 by Cohort
    • To evaluate the percentage of bleed treatments resulting in effective hemostasis at 24 hours
    Fase 1
    • Valutare la PK di dosi crescenti somministrate per via sottocutanea (sc) di MarzAA e confermare la dose per la fase 2
    Fase 2
    • Valutare l’efficacia di MarzAA per il trattamento al bisogno e il controllo degli episodi emorragici a 24 ore
    E.2.2Secondary objectives of the trial
    Phase 1 by Cohort
    • To determine the pharmacokinetics of IV and SC MarzAA
    • To determine if the pharmacokinetics of IV and SC MarzAA are dose-proportional
    • To determine the pharmacodynamics of IV and SC MarzAA
    Phase 2 by Cohort
    • To assess the time to cessation of bleeding after the initial dose
    • To assess the ability of MarzAA to achieve and maintain hemostasis in the treatment of bleeds at fixed time points
    • To assess the number of doses and the cumulative dose needed to achieve hemostasis for individual bleeds
    • To assess the percentage of bleeds with treatment success at 24 hours that maintain hemostatic efficacy at 48 hours after the initial dose
    • To determine the use and amount of rescue therapy needed in treatment failures
    • To assess the pharmacokinetics and pharmacodynamics of MarzAA in the bleeding state
    Fase 1
    • Determinare la farmacocinetica di MarzAA somministrato per via endovenosa (ev) e sc
    • Determinare se la farmacocinetica di MarzAA ev e sc è proporzionale alla dose
    • Determinare la farmacodinamica di MarzAA ev e sc
    Fase 2
    • Valutare il tempo di arresto dei sanguinamenti
    • Valutare la capacità di MarzAA di raggiungere e mantenere l’emostasi nel trattamento dei sanguinamenti in punti temporali fissati
    • Valutare il numero di dosi e la dose cumulativa necessari per raggiungere un’emostasi adeguata per i singoli sanguinamenti
    • Valutare la percentuale di sanguinamenti trattati in modo efficace a 24 ore che mantengono l’efficacia emostatica a 48 ore dalla dose iniziale
    • Valutare l’uso e la quantità di terapie di salvataggio necessarie in caso di fallimenti terapeutici
    • Valutare la farmacocinetica e la farmacodinamica di MarzAA nello stato emorragico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Confirmed diagnosis of cohort:
    a) Confirmed diagnosis of congential FVIID
    b) Confirmed diagnosis of congenital GT (ie, platelet function analyzer, mutational analysis)
    c) Confirmed diagnosis of congenital HAwI-E treated with the same dose of emicizumab for at least 4 weeks and with one of the following:
    i) Titer =5 BU
    ii) Titer =0.6 BU but expected to have a high anamnestic response to FVIII, as demonstrated from the subject’s medical history, precluding the use of FVIII products to treat bleeding as documented by the Investigator
    iii) Titer =0.6 BU but expected to be refractory to increased dosing of FVIII, as demonstrated from the subject’s medical history, precluding the use of FVIII products to treat bleeding as documented by in the Investigator
    Note: documentation of highest historic titer should be recorded.
    2) History of bleeding with an
    a) ABR of =8 for FVIID
    b) ABR of =8 for GT
    c) ABR of =1 for HAwI-E
    3) Male or female, age =12 years
    4) Agreement to use highly effective birth control throughout the study if the subject has childbearing potential
    5) If female, the subject must meet the following criteria:
    a) Not currently be breastfeeding
    b) Not plan on becoming pregnant during the study
    c) Be surgically sterile, or at least 2 years postmenopausal, or have a negative serum pregnancy test at Screening (Visit 1)
    6) Affirmation of informed consent with signature confirmation and assent for children from age 12 to 17 years before any study-related activities
    Note: study-related activities are any procedure that would not have been performed during normal clinical management of the subject
    7) Stated willingness to comply with all study procedures and availability for the duration of the study
    8) Investigator confirmed subject’s ability to rapidly assess a bleeding episode and respond appropriately
    9) Investigator confirmed subject’s ability to administer MarzAA SC at home
    1) Diagnosi confermata per tre coorti:
    a) Coorte 1:diagnosi confermata di FVIID
    b) Coorte 2:diagnosi confermata di GT (analizzatore della funzione piastrinica, analisi mutazionale)
    c) Coorte 3:diagnosi confermata di HAwI-E trattata con la stessa dose di emicizumab per almeno 4 settimane con uno dei seguenti titoli di inibitori:
    i) =5 unità Bethesda (BU)
    ii) =0,6 BU, ma con previsione di un’elevata risposta anamnestica al FVIII (come dimostrato dall’anamnesi del soggetto), che preclude l’uso di prodotti a base di FVIII per il trattamento dei sanguinamenti, come documentato dallo sperimentatore
    iii) =0,6 BU, ma con previsione di refrattarietà all’aumento della dose di FVIII (come dimostrato dall’anamnesi del paziente), che preclude l’uso di prodotti a base di FVIII per il trattamento dei sanguinamenti, come documentato dallo sperimentatore
    Nota: si deve registrare la documentazione relativa al titolo più elevato in anamnesi.
    2) Anamnesi positiva per sanguinamenti:
    a) Coorte 1:ABR =8 per FVIID
    b) Coorte 2:ABR =8 per GT
    c) Coorte 3:ABR =1 per HAwI-E
    3) Soggetti di sesso maschile o femminile, età =12 anni
    4) Consenso all’uso di un metodo contraccettivo altamente efficace nel corso dello studio, nel caso in cui il soggetto sia potenzialmente fertile
    5) Se il soggetto è di sesso femminile, deve rispondere ai seguenti criteri:
    a) Non deve essere in allattamento
    b) Non deve pianificare gravidanze nel corso dello studio
    c) Deve essere stata sottoposta a sterilizzazione chirurgica, essere in menopausa da almeno 2 anni o aver ottenuto un risultato negativo al test di gravidanza su siero allo screening (visita 1)
    6) Rilascio del consenso informato con conferma della firma e dell’assenso per i soggetti di età compresa tra 12 e 17 anni prima di qualsiasi attività correlata allo studio
    Nota: le attività correlate allo studio sono procedure non previste nell’ambito della normale gestione clinica del soggetto
    7) Intenzione dichiarata di attenersi a tutte le procedure dello studio e disponibilità per la durata dello studio
    8) Capacità del soggetto, confermata dallo sperimentatore, di valutare rapidamente un episodio emorragico e di rispondere in modo adeguato
    9) Capacità del soggetto, confermata dallo sperimentatore, di somministrarsi MarzAA presso il proprio domicilio
    E.4Principal exclusion criteria
    1) Cohort 1: genotype of FVIID subjects with following mutations:
    a) P.A354V-p.464Hfs
    b) P.Ser112-Stop (homozygous)
    c) Ala294Val + Del C
    d) 100GLN - ARG shift
    e) Ser103 - Gly
    Note: documentation of historic genotype would be acceptable
    2) Inability to discontinue and washout any prophylactic (except Hemlibra) or episodic treatment for 5 days and 10 days for platelet transfusion prior to dosing
    3) Previous participation in a clinical study involving SC administration of wt-rFVIIa (NovoSeven or MOD-5014) or any study using a modified amino-acid sequence FVIIa (other than MarzAA) such as: NN1731 or BAY86-6150.
    Note: Prior participation in a study of intravenous (IV) LR769, rFVIIa-FP (CSL689), or MarzAA is permissible
    4) Previous participation in a clinical study with treatment within the previous 30 days or =5 half-lives (of the investigation product) or absence of clinical effect, whichever is longer
    5) Known positive antibody to FVIIa or variants thereof detected during screening or prior to Day 1
    6) Known hypersensitivity to pd-FVIIa, pd-FVII, wt-rFVIIa, or MarzAA or any of the excipients or related products
    7) Treatment with anticoagulants or antiplatelet therapy within 1 week of enrollment or anticipated need during the study
    8) Planned elective surgery within 12 months following study entry
    9) History of clinically relevant coagulation blood disorders
    10) CD 4 T cell count of <200 cells/mm3
    11) Platelet count <50,000 /µL based on screening laboratory assessments
    12) Current or history of advanced atherosclerotic disease (ie, known history of coronary artery disease, ischemic stroke, etc), or deep venous thrombosis (DVT) within 24 months of dosing or considered to be at a high risk of venous thromboembolic event (VTE) as judged by the Investigator
    13) Compromised hepatic or renal function:
    a) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels =5 × the upper limit of normal (ULN)
    b) Total bilirubin level =2 mg/dL (>35 µmol/L) unless there is a known history of Gilbert’s syndrome
    c) Serum creatinine level >1.25 × ULN
    14) Inability or medical, psychosocial, or familial issues that might prevent full participation and cooperation with the procedures and requirements of the clinical study as determined by the potential subject and physician/Investigator
    15) Weight =105 kg
    1) Coorte 1: soggetti con genotipo associato al FVIID che presentano le seguenti mutazioni:
    a) P.A354V-p.464Hfs
    b) P.Ser112-Stop (omozigote)
    c) Ala294Val + Del C
    d) 100GlnArg
    e) Ser103Gly
    Nota: è accettabile la documentazione pregressa del genotipo.
    2) Impossibilità di interrompere e non assumere qualsiasi trattamento profilattico (a eccezione di Hemlibra) o episodico per 5 giorni prima della somministrazione e per 10 giorni prima della somministrazione in caso di trasfusione di piastrine.
    3) Precedente partecipazione a uno studio clinico in cui fosse prevista la somministrazione sc di rFVIIa (NovoSeven o MOD-5014) o a qualsiasi studio in cui fosse previsto l’impiego di un FVIIa con sequenza aminoacidica modificata (diverso da MarzAA), tra cuiNN1731 o BAY86-6150.
    Nota: la precedente partecipazione a uno studio su LR769 ev, rFVIIa-FP (CSL689) o MarzAA è ammissibile.
    4) Precedente partecipazione a uno studio clinico con trattamento somministrato nei 30 giorni precedenti oppure entro la durata di =5 emivite del prodotto sperimentale o assenza di efficacia clinica, in base al periodo più lungo.
    5) Positività nota agli anticorpi anti-FVIIa o relative varianti rilevata durante lo screening o prima del giorno 1
    6) Ipersensibilità nota al fattore VIIa derivato da plasma, al fattore VII derivato da plasma, al wt-rFIIa, a MarzAA o a uno qualsiasi degli eccipienti o prodotti correlati
    7) Trattamento con anticoagulanti o antipiastrinici nella settimana precedente l’arruolamento o necessità prevista di ricorrere a tale tipo di trattamento nel corso dello studio
    8) Intervento chirurgico elettivo programmato nei 12 mesi successivi all’ingresso nello studio
    9) Anamnesi positiva per altre coagulopatie clinicamente rilevanti
    10) Conta piastrinica <50.000/µL in base alle valutazioni di laboratorio eseguite allo screening
    11) Malattia aterosclerotica avanzata (anamnesi positiva per malattia coronarica, ictus ischemico ecc.) in atto o pregressa, o trombosi venosa profonda nei 24 mesi precedenti la somministrazione, oppure alto rischio di eventi tromboembolici venosi o embolia polmonare secondo il giudizio dello sperimentatore
    12) Conta dei linfociti T CD 4 <200 cellule/mm3
    13) Compromissione epatica o renale:
    a) livelli di alanina aminotransferasi e aspartato aminotransferasi =5 × il limite superiore della norma (ULN)
    b) livelli di bilirubina totale =2 mg/dL (>35 µmol/L), salvo in caso di anamnesi positiva per sindrome di Gilbert
    c) livelli di creatinina sierica >1,25 × ULN
    14) Incapacità o problemi di natura medica, psicosociale o familiare che, secondo il giudizio dello sperimentatore e del potenziale soggetto, potrebbero impedire la piena partecipazione e collaborazione allo svolgimento delle procedure dello studio e al rispetto dei requisiti dello studio
    15) Peso =105 kg
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1 by Cohort
    • Pharmacokinetics of ascending SC doses of MarzAA by dose level/stage and confirm the Phase 2 dose
    Phase 2 by Cohort
    • Percentage of bleed treatments resulting in effective hemostasis at 24 hours
    Fase 1
    Farmacocinetica di dosi crescenti somministrate per via sc di MarzAA e conferma della dose per la fase 2
    Fase 2
    Percentuale di trattamenti per gli episodi emorragici che determinano un’emostasi efficace a 24 ore
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1 - 6 weeks into the study
    Phase 2 - on a monthly basis
    Fase 1 - 6 settimane nello or dentro lo studio
    Fase 2 - su base mensile
    E.5.2Secondary end point(s)
    Phase 1 by Cohort
    • Pharmacokinetics of IV and SC MarzAA
    • Pharmacokinetic assessment of dose proportionality
    • Pharmacodynamics of IV and SC MarzAA
    Phase 2 by Cohort
    • The time to cessation of bleeding after the initial dose
    • Percentage of bleed treatment resulting in effective hemostasis at the time points of 1, 3, 6, 9, 12, and 48 hours after initial dose
    • Number of doses and cumulative dose needed to achieve hemostasis for individual bleeds
    • Percentage of bleeds with treatment success at 24 hours that demonstrated maintenance of efficacy at 48 hours after the initial dose
    • Use and amount of rescue therapy needed in treatment failures
    • Pharmacokinetics and pharmacodynamics of MarzAA in the bleeding state
    Fase 1
    • Farmacocinetica di MarzAA ev e sc
    • Valutazione farmacocinetica della proporzionalità della dose
    • Farmacodinamica di MarzAA ev e sc
    Fase 2
    • Tempo all’arresto dell’emorragia dopo la dose iniziale
    • Percentuale di trattamenti per gli episodi emorragici che determinano un’emostasi efficace a 1, 3, 6, 9, 12 e 48 ore dalla dose iniziale
    • Numero di dosi e dose cumulativa necessaria per raggiungere un’emostasi adeguata per i singoli sanguinamenti
    • Valutare la percentuale di sanguinamenti trattati in modo efficace a 24 ore che mantengono l’efficacia emostatica a 48 ore dalla dose iniziale
    • Uso e quantità di terapie di salvataggio necessarie in caso di fallimenti terapeutici
    • Farmacocinetica e farmacodinamica di MarzAA nello stato emorragico
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase 1 - 6 weeks into the study
    Phase 2 - on a monthly basis
    Fase 1 - 6 settimane nello or dentro lo studio
    Fase 2 - su base mensile
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety, Pharmacokinetic, Pharmacodynamic
    Safety, Pharmacokinetic, Pharmacodynamic
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 concerned6
    E.8.5The trial involves multiple Member States No
    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
    India
    Russian Federation
    Ukraine
    United States
    Italy
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 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: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 24
    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)
    No post-study therapy is planned
    No post-study therapy is planned
    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 Decision2021-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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