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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    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:2016-004550-15
    Sponsor's Protocol Code Number:64179375THR2001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-15
    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 number2016-004550-15
    A.3Full title of the trial
    A Randomized, Double-blind, Double-dummy, Multicenter, Adaptive Design Dose-Escalation (Part 1) and Dose-Response (Part 2) Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery
    Uno studio multicentrico, randomizzato, in doppio cieco, doppio mascheramento, con disegno adattivo, di escalation della dose (Parte 1) e risposta alla dose (Parte 2) per valutare la sicurezza e l¿efficacia di JNJ-64179375 per via endovenosa rispetto ad apixaban per via orale in soggetti sottoposti a intervento elettivo di protesi totale del ginocchio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 2-Part Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement
    Uno studio in due parti per valutare la sicurezza e l'efficacia di JNJ-64179375 per via endovenosa rispetto ad Apixaban per via orale in soggetti sottoposti a intervento elettivo di protesi totale del ginocchio
    A.3.2Name or abbreviated title of the trial where available
    A 2-Part Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban
    Uno studio in due parti per valutare la sicurezza e l'efficacia di JNJ-64179375 per via endovenosa r
    A.4.1Sponsor's protocol code number64179375THR2001
    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 SponsorJANSSEN CILAG INTERNATIONAL NV
    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 supportJanssen Research and Development, LLC
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportJanssen-Cilag International NV
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportJanssen Cilag S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0
    B.5.5Fax number0
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameJNJ-64179375
    D.3.2Product code JNJ-64179375
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeJNJ-64179375
    D.3.9.4EV Substance CodeSUB184322
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name ELIQUIS
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb/Pfizer EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPIXABAN
    D.3.9.1CAS number 503612-47-3
    D.3.9.2Current sponsor code80000-G-109
    D.3.9.4EV Substance CodeSUB25425
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Thromboembolism in subjects who have undergone an elective primary unilateral total knee replacement
    Tromboembolia in soggetti sottoposti a intervento elettivo di protesi unilaterale totale del ginocchio
    E.1.1.1Medical condition in easily understood language
    Prevention of forming a blood clot following surgery for replacement of the knee
    Prevenzione della formazione di un coagulo di sangue dopo l'intervento chirurgico di protesi del ginocchio
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10007541
    E.1.2Term Cardiac disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1: The primary objective is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation within Part 1 and any bleeding events (the composite of major, clinically relevant nonmajor, and minimal bleeding events) for the selection of doses for Part 2.

    Part 2: The primary objective is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep-vein thrombosis (DVT) [asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic], nonfatal PE, or any death).
    Parte 1: L¿obiettivo primario ¿ valutare la sicurezza e la tollerabilit¿ di JNJ-64179375 per ogni livello di dose per l¿escalation della dose nell¿ambito della Parte 1 dello studio e gli eventi di sanguinamento di qualsiasi tipo (endpoint composito costituito dagli eventi di sanguinamento maggiori, non maggiori clinicamente rilevanti e minimi) per la selezione delle dosi da utilizzare nella Parte 2.
    Parte 2: L¿obiettivo primario ¿ valutare la relazione dose-risposta di efficacia di JNJ-64179375 relativamente alla prevenzione della TEV totale (TVP prossimale e/o distale [asintomatica confermata da valutazione flebografica della gamba operata o sintomatica confermata oggettivamente], EP non fatale e decesso di qualsiasi tipo).
    E.2.2Secondary objectives of the trial
    Part 1 :
    ¿ to assess the dose response of JNJ-64179375 for the occurrence of the composite endpoint of any bleeding events, the composite endpoint of major or clinically relevant nonmajor bleeding events, and the individual components of the composite endpoint of any bleeding event
    ¿ to assess the dose response of JNJ-64179375 for the prevention of total VTE and the individual components of total VTE
    Part 2:
    ¿ to assess the dose response of JNJ-64179375 for the occurrence of the composite endpoint of any bleeding events, the composite endpoint of major or clinically relevant nonmajor bleeding events, and the individual components of the composite endpoint of any bleeding event
    ¿ to assess the dose response of JNJ-64179375 for the prevention of major VTE and the individual components of the total VTE endpoint


    Please refer to the protocol for further secondary objectives common to both Part 1 and Part 2
    Parte 1
    Valutare:
    ¿ risposta a dose di JNJ-64179375 all¿occorrenza dell¿endpoint composito degli eventi di sanguinamento di qualsiasi tipo, dell¿endpoint composito degli eventi di sanguinamento maggiori o non maggiori clinicamente rilevanti e dei singoli componenti dell¿endpoint composito degli eventi di sanguinamento di qualsiasi tipo
    ¿ risposta a dose di JNJ-64179375 per la prevenzione della TEV totale e dei singoli componenti della TEV totale
    Parte 2
    Valutare:
    ¿ risposta a dose di JNJ-64179375 all¿occorrenza dell¿endpoint composito degli eventi di sanguinamento di qualsiasi tipo, dell¿endpoint composito degli eventi di sanguinamento maggiori o non maggiori clinicamente rilevanti e dei singoli componenti dell¿endpoint composito degli eventi di sanguinamento di qualsiasi tipo
    ¿ risposta a dose di JNJ-64179375 per la prevenzione della TEV maggiore e dei singoli componenti dell¿endpoint della TEV totale

    Rif. a protocollo per ulteriori obiettivi secondari comuni alle Parti 1 e 2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female of non-childbearing potential
    - At least 50 years of age or older
    - Weight 40 kg to 150 kg
    - Medically appropriate for postoperative anticoagulant prophylaxis
    - Has undergone an elective primary unilateral TKR
    - Uomini e donne non fertili
    - Almeno 50 anni di età
    - Peso compreso tra 40 e 150 kg inclusi
    - Idoneità, dal punto di vista medico, alla profilassi anticoagulante post-operatoria
    - Intervento elettivo di protesi totale del ginocchio unilaterale primaria
    E.4Principal exclusion criteria
    - Any condition for which the use of apixaban is not recommended in the opinion of the investigator
    - Bilateral, revision or unicompartmental procedure
    - Known or suspected hypersensitivity or intolerance to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or any of the excipients of JNJ-64179375
    - Unable to undergo venography
    - Known previous DVT in either lower extremity
    - Any preplanned invasive procedure (eg, surgery, colonoscopy) up to Week 18 for which anticoagulant or antiplatelet therapy would be interrupted
    - Planned use of intermittent pneumatic compression after randomization
    - Qualsiasi condizione per la quale, secondo il giudizio dello sperimentatore, non sia consigliato l’uso di apixaban
    - Procedura bilaterale, di revisione o monocompartimentale
    - Ipersensibilità o intolleranza nota o presunta a qualsiasi trattamento biologico oppure allergie o reazioni clinicamente significative note a proteine murine, chimeriche o umane, anticorpi monoclonali o frammenti di anticorpi o a qualsiasi eccipiente di JNJ-64179375
    - Impossibilità di sottoporsi a una flebografia
    - TVP pregressa nota a uno degli arti inferiori
    - Qualsiasi procedura invasiva (ad es. intervento chirurgico, colonscopia) già programmata fino alla Settimana 18 che comporterebbe l’interruzione della terapia anticoagulante o antipiastrinica
    - Utilizzo programmato della compressione pneumatica intermittente dopo la randomizzazione
    E.5 End points
    E.5.1Primary end point(s)
    The endpoints of the study will be the same for Parts 1 and 2 although the focus of Part 1 will be primarily dose escalation based on safety while the focus of Part 2 will primarily be the assessment of dose response in both safety and efficacy.
    Common Endpoints in Parts 1 and 2
    Primary Safety Endpoint
    The primary safety endpoint is any bleeding event defined as the composite of major, clinically relevant nonmajor, and minimal bleeding events assessed through the Day 10-14 visit.
    Primary Efficacy Endpoint
    The primary efficacy endpoint is total VTE, defined as the composite of proximal and/or distal DVT (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal PE, or any death assessed through the Day 10-14 visit.
    Gli endpoint dello studio saranno gli stessi per le Parti 1 e 2 anche se la Parte 1 sarà incentrata principalmente sull’escalation della dose in funzione della sicurezza, mentre la Parte 2 sarà incentrata principalmente sulla valutazione della relazione dose-risposta in termini di sicurezza ed efficacia.
    Endpoint comuni alle Parti 1 e 2
    Endpoint di sicurezza primario
    L’endpoint di sicurezza primario consiste negli eventi di sanguinamento di qualsiasi tipo ed è definito come un endpoint composito costituito dagli eventi di sanguinamento maggiori, gli eventi di sanguinamento non maggiori clinicamente rilevanti e gli eventi di sanguinamento minimi valutati fino alla visita del Giorno 10-14.
    Endpoint di efficacia primario
    L’endpoint di efficacia primario è la TEV totale ed è definito come un endpoint composito costituito dalla TVP prossimale e/o distale (asintomatica confermata da valutazione flebografica della gamba operata o sintomatica confermata oggettivamente), l’EP non fatale e il decesso di qualsiasi tipo valutati fino alla visita del Giorno 10-14.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through the Day 10-14 visit
    Fino alla visita del Giorno 10-14
    E.5.2Secondary end point(s)
    Key Secondary Endpoints
    The key secondary endpoints are the assessment of the primary endpoints through the Week 18 visit, and:
    ¿ All individual components of the primary safety endpoint (major bleeding, clinically relevant nonmajor bleeding, and minimal bleeding)
    ¿ Composite of major and clinically relevant nonmajor bleeding
    ¿ Major VTE, a composite of proximal DVT (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal PE, or any death
    ¿ All individual components of the primary efficacy endpoint (ie, proximal and/or distal DVT [asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic], nonfatal PE, any death) Other Secondary Endpoints
    ¿ Any wound or joint complication in the operated leg
    Principali endpoint secondari
    I principali endpoint secondari sono la valutazione degli endpoint primari fino alla visita della Settimana 18 e:
    ¿ Tutti i singoli componenti dell¿endpoint di sicurezza primario (sanguinamento maggiore, sanguinamento non maggiore clinicamente rilevante e sanguinamento minimo)
    ¿ Endpoint composito costituito da sanguinamento maggiore e sanguinamento non maggiore clinicamente rilevante
    ¿ TEV maggiore, ovvero un endpoint composito costituito dalla TVP prossimale (asintomatica confermata da valutazione flebografica della gamba operata o sintomatica confermata oggettivamente), l¿EP non fatale e il decesso di qualsiasi tipo
    ¿ Tutti i singoli componenti dell¿endpoint di efficacia primario (TVP prossimale e/o distale [asintomatica confermata da valutazione flebografica della gamba operata o sintomatica confermata oggettivamente], EP non fatale e decesso di qualsiasi tipo)
    Altri endpoint secondari
    ¿ Complicazioni della ferita o a carico dell¿articolazione di qualsiasi tipo nella gamba operata
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through the Week 18 visit
    Fino alla visita della Settimana 18
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Immunogenicit¿
    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) 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial11
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA74
    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
    Argentina
    Belgium
    Brazil
    Bulgaria
    Canada
    Czechia
    Hungary
    Italy
    Japan
    Latvia
    Lithuania
    Malaysia
    Poland
    Romania
    Russian Federation
    Spain
    Sweden
    Turkey
    Ukraine
    United States
    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
    Last visit last subject
    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 months10
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days17
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 736
    F.4.2.2In the whole clinical trial 1500
    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)
    It is not planned to treat subjects with JNJ-64179375 any further than scheduled in this study protocol. The study drug is for experimental use only.
    Non ¿ previsto il trattamento dei soggetti con JNJ-64179375 pi¿ di quanto previsto in questo protocollo di studio. Il farmaco di studio ¿ solo per uso sperimentale.
    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 Decision2017-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA