Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43854   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-001048-24
    Sponsor's Protocol Code Number:NN7769-4514
    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:2021-06-07
    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 number2020-001048-24
    A.3Full title of the trial
    A multinational, open-label, randomised, controlled trial to investigate efficacy and safety of NNC0365-3769 (Mim8) in adults and adolescents with haemophilia A with or without inhibitors.
    Studio internazionale, in aperto, randomizzato e controllato per la valutazione dell'efficacia e della sicurezza di NNC0365-3769 (Mim8) in adulti e adolescenti affetti da emofilia A con o senza inibitori
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study investigating Mim8 in adults and adolescents with haemophilia A with or without inhibitors.
    Studio clinico sull'utilizzo di Mim8 in persone adulte e adolescenti con emofilia A con o senza inibitori.
    A.3.2Name or abbreviated title of the trial where available
    FRONTIER 2
    FRONTIER 2
    A.4.1Sponsor's protocol code numberNN7769-4514
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1249-4378
    A.5.4Other Identifiers
    Name:FRONTIER 2Number:NN7769-4514
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/450/2020
    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 Transparency (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
    D.3.2Product code [NNC0365-3769 A]
    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.3.9.2Current 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 typerange
    D.3.10.3Concentration number10 to 100
    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
    Haemophilia A
    Haemophilia A with inhibitors
    Emofilia A
    Emofilia A con inibitori
    E.1.1.1Medical condition in easily understood language
    Bleeding disorder inherited deficiency in clotting factor VIII
    Bleeding disorder inherited deficiency in clotting factor VIII with antibodies to clotting factor replacement therapy
    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 10018938
    E.1.2Term Haemophilia A (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 10053751
    E.1.2Term Hemophilia A with anti 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 confirm the haemostatic effect of Mim8 as treatment prophylaxis for adult and adolescent patients with haemophilia A with or without inhibitors.
    Confermare l'effetto emostatico di Mim8 come trattamento di profilassi per pazienti adulti e adolescenti con emofilia A con o senza inibitori.
    E.2.2Secondary objectives of the trial
    1. To investigate safety of Mim8 prophylaxis in adults and adolescents with haemophilia A with or without FVIII inhibitors.
    2. To evaluate the consumption of factor product per bleed treatment (number of injections) after Mim8 prophylaxis in adults and adolescents with haemophilia A with or without inhibitors.
    3. To evaluate the development of anti-Mim8 antibodies after Mim8 prophylaxis in adults and adolescents with haemophilia A with or without inhibitors.
    4. To evaluate treatment burden after Mim8 prophylaxis in adults and adolescents with haemophilia A with or without inhibitors.
    5. To evaluate aspects of patient's physical functioning after Mim8 prophylaxis in adults and adolescents with haemophilia A with or without inhibitors.
    6. To evaluate joint pain intensity after Mim8 prophylaxis in adults and adolescents with haemophilia A with or without inhibitors.
    1. Indagare sulla sicurezza del regime di profilassi con Mim8 in adulti e adolescenti con emofilia A con o senza inibitori.
    2. Valutare il consumo del fattore per il trattamento di episodi di sanguinamento (numero di iniezioni) dopo la profilassi con Mim8 in adulti e adolescenti con emofilia A con o senza inibitori.
    3. Valutare lo sviluppo di anticorpi anti-Mim8 dopo la profilassi con Mim8 in adulti e adolescenti con emofilia A con o senza inibitori.
    4. Valutare gli effetti negativi del trattamento dopo la profilassi con Mim8 in adulti e adolescenti con emofilia A con o senza inibitori.
    5. Valutare gli aspetti delle abilità funzionali fisiche del paziente dopo la profilassi con Mim8 in adulti e adolescenti con emofilia A con o senza inibitori.
    6. Valutare l’intensità del dolore alle articolazioni dopo la profilassi con Mim8 in adulti e adolescenti con emofilia A con o senza inibitori.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed consent obtained before any trial-related activities. Trialrelated activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
    - Male or female with diagnosis of congenital haemophilia A of any severity based on medical records
    - Patient has been prescribed, or in need of, treatment with factor VIII or bypassing agent in the last 26 weeks prior to screening
    - Age above or equal to 12 years at the time of signing informed consent.
    - Body weight above or equal to 30 kg
    - Applicable to patients on emicizumab prophylaxis: patient is willing to discontinue emicizumab at the time of screening
    - Applicable to patients treated with no prophylaxis prior to enrolment: 5 or more bleeds in the last 26 weeks prior to screening visit
    - Applicable to patients with FVIII activity above 1% who are on prophylactic treatment: 1 or more bleeds in the last 26 weeks prior to screening visit
    - Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires
    -Modulo di consenso informato ottenuto prima di qualsiasi attività correlata alla sperimentazione. Per attività correlate alla sperimentazione si intende qualunque procedura svolta all’interno dello studio, incluse le attività necessarie a stabilire l’idoneità a partecipare.
    -Soggetti di sesso maschile o femminile con diagnosi di emofilia A congenita di qualsiasi severità basata su referti medici
    -Al paziente è stata prescritta o è stata segnalata la necessità di trattamento con fattore VIII o agenti bypassanti nelle 26 settimane precedenti lo screening
    -Età maggiore o uguale a 12 anni al momento della firma del modulo di consenso informato
    -Peso corporeo =30,0 kg
    -Applicabile ai pazienti in profilassi con emicizumab: il paziente è disposto a interrompere il trattamento con emicizumab allo screening
    -Applicabile ai pazienti trattati on-demand/non in regime di profilassi prima dell'arruolamento: =5 sanguinamenti nelle 26 settimane prima della visita di screening
    -Applicabile ai pazienti con attività del fattore VIII >1% in regime di profilassi: =1 sanguinamento/i nelle 26 settimane prima della visita di screening
    -Volontà e capacità di aderire alle visite programmate e alle procedure dello studio, inclusa la compilazione del diario e dei questionari per il paziente
    E.4Principal exclusion criteria
    - Previous participation in this trial. Participation is defined as signed informed consent
    - Participation in any clinical trial of an approved or non-approved investigational medicinal product, within 30 days (or 5 half-lives of the investigational medicinal product, whichever is greater) before screening
    - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (highly effective contraceptive measures as defined in the protocol or as required by local regulation or practice). Breast feeding is allowed only during the run-in period
    - Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
    - Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products
    - Receipt of gene therapy at any given time point
    - Ongoing or planned immune tolerance induction (ITI) therapy
    - Major surgery planned at the time of screening
    - Known congenital or acquired coagulation disorders other than haemophilia A
    - Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit combined with total bilirubin above 1.5 times the upper limit measured at screening
    - Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below or equal to 30 ml/min/1.73 m^2 for serum creatinine measured at screening
    - Previous or current thromboembolic disease or events (includes arterial and venous thrombosis including myocardial infarction, thrombotic
    microangiography (TMA), pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events and peripheral artery occlusion) (with the exception of previous catheter-associated thrombosis for which antithrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator
    - Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
    - Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator
    -Precedente partecipazione a questo studio. La partecipazione è intesa come firma del consenso informato
    -Partecipazione a qualsiasi studio clinico con un prodotto sperimentale approvato o non approvato nei 30 giorni (o 5 emivite del prodotto sperimentale, in base a quale periodo è più lungo) prima dello screening
    -Donne in gravidanza, in allattamento o che intendano intraprendere una gravidanza o fertili e che non usano un metodo contraccettivo efficace (metodi contraccettivi efficaci come definiti nel protocollo o come richiesto dalla legge locale). L’allattamento è consentito solo nel periodo di run-in
    -Qualsiasi disturbo, eccetto le condizioni associate all’emofilia A, che a giudizio dello sperimentatore, potrebbe mettere a rischio la sicurezza del paziente o la conformità al protocollo
    -Ipersensibilità nota o sospetta al/ai prodotto/i sperimentale/i, a qualsiasi dei costituenti del prodotto o ai prodotti correlati
    -Trattamento con terapia genica in qualsiasi momento
    -Terapia ITI in corso o pianificata
    -Chirurgie maggiori pianificate al momento dello screening
    -Disturbi della coagulazione noti congeniti o acquisiti oltre all’emofilia A
    -Disfunzione epatica definita come AST e/o ALT >3 volte il limite superiore associati a bilirubina totale >1.5 volte il limite superiore allo screening
    -Disfunzione renale definita come velocità di filtrazione glomerulare stimata (eGFR) =30 ml/min/1.73 m2 per la creatinina sierica misurata allo screening
    -Malattia tromboembolica precedente o attuale o eventi (inclusi trombosi a carico delle arterie e delle vene incluso infarto del miocardio, microangiopatia trombotica (TMA), embolia polmonare, infarto/trombosi cerebrale, trombosi delle vene profonde, altri eventi tromboembolici clinicamente significativi e occlusione delle arterie periferiche) (fanno eccezione eventi precedenti di trombosi associati all’uso di catetere per i quali trattamenti anti-trombotici non sono in corso) o rischio di malattia tromboembolica a giudizio dello sperimentatore
    -Incapacità mentale, riluttanza a cooperare o presenza di una barriera linguistica che precluda comprensione e cooperazione adeguate
    -Altre condizioni (e.g. malattie autoimmuni) o anomalie di laboratorio che potrebbero incrementare il rischio di sanguinamento o trombosi a giudizio dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    Number of treated bleeds
    Numero dei sanguinamenti trattati
    E.5.1.1Timepoint(s) of evaluation of this end point
    - No prophylaxis treatment (Arms 1 and 2): From randomisation (week 0) to end of main (week 26)
    - Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from randomisation (week 0) to end of main (week 26)
    -Nessun trattamento di profilassi (bracci 1 e 2): Dalla randomizzazione (settimana 0) alla fine della fase principale (settimana 26)
    -Trattamento di profilassi (bracci 3 e 4): Dall’inizio del run-in (26-52 settimane prima della settimana 0) alla settimana 0 e dalla randomizzazione (settimana 0) alla fine della fase principale (settimana 26)
    E.5.2Secondary end point(s)
    1. Number of injection site reactions
    2. Occurrence of antiMim8 antibodies
    3. Number of treated spontaneous bleeds
    4. Number of treated joint bleeds
    5. Number of treated traumatic bleeds
    6. Number of target joint bleeds
    7. Consumption of factor product per bleed treatment (number of injections)
    8. Change in physical function domain of paediatric quality of life inventory (PEDS-QL)
    9. Change in patient's treatment burden using the haemophilia treatment experience measure (Hemo-TEM)
    10. Change in patient's joint pain score using Joint Pain Rating Scale
    1. Numero di reazioni al sito d’iniezione
    2. Casi di sviluppo di anticorpi anti-Mim8
    3. Numero di sanguinamenti spontanei trattati
    4. Numero di sanguinamenti alle articolazioni trattati
    5. Numeri di sanguinamenti traumatici trattati
    6. Numero di sanguinamenti alle articolazioni target
    7. Consumo di fattori per il trattamento di sanguinamenti (numero di iniezioni)
    8. Cambiamenti nel dominio funzionale fisico PEDS-QL (paediatric quality of life inventory)
    9. Cambiamenti negli effetti negativi del trattamento misurati con l’Hemo-TEM (haemophilia treatment experience measure)
    10. Cambiamento nel punteggio del dolore alle articolazioni del paziente usando la Joint Pain Rating Scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. All subjects receiving Mim8 (Arms 2, 3 and 4): From randomisation (week 0) to end of main (week 26)
    2. All subjects receiving Mim8 (Arms 2, 3 and 4): From randomisation (week 0) to end of extension (week 52)
    3. – 7.:- No prophylaxis treatment (Arms 1 and 2): From randomisation (week 0) to end of main (week 26)
    - Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from randomisation (week 0) to
    end of main (week 26)
    8. – 10.: All subjects (Arms 1, 2, 3 and 4): From randomisation (week 0) to the end of the main part (week 26)
    1. Tutti i pazienti che ricevono Mim8 (bracci 2, 3 e 4): dalla randomizzazione (settimana 0) alla fine della fase principale (settimana 26)
    2. Tutti i pazienti che ricevono Mim8 (bracci 2, 3 e 4): dalla randomizzazione (settimana 0) alla fine della fase di estensione (settimana 52)
    3. - 7.: -Nessun trattamento di profilassi (bracci 1 e 2): Dalla randomizzazione (settimana 0) alla fine della fase principale (settimana 26)
    -Trattamento di profilassi (bracci 3 e 4): Dall’inizio del run-in (26-52 settimane prima della settimana 0) alla settimana 0 e dalla randomizzazione (settimana 0) alla fine della fase principale (settimana 26)
    8. – 10.:Tutti i pazienti (bracci 1, 2, 3 e 4): Dalla randomizzazione (settimana 0) alla fine della fase principale (settimana 26)
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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 Yes
    E.8.1.7.1Other trial design description
    Confronto intra-individuale (tra pazienti)
    Intra-individual (within-patient) comparison
    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
    Differenti regimi di trattamento di Mim8
    Different treatment regimen of Mim8
    E.8.2.4Number of treatment arms in the trial4
    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 EEA53
    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
    Canada
    China
    India
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    Saudi Arabia
    Serbia
    South Africa
    Taiwan
    Turkey
    United States
    Switzerland
    European Union
    United Kingdom
    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 months3
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days4
    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: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 99
    F.4.2.2In the whole clinical trial 230
    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 Decision2021-03-25
    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 StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 23 09:32:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA