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    Summary
    EudraCT Number:2016-004550-15
    Sponsor's Protocol Code Number:64179375THR2001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-31
    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 ConcernedSpain - AEMPS
    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
    Estudio aleatorizado, doble ciego, doble simulación, multicéntrico, de diseño adaptativo de escalada de dosis (Parte 1) y dosis-respuesta (parte 2) para evaluar la seguridad y la eficacia de JNJ-64179375 frente a Apixaban oral en sujetos sometidos a un reemplazo total de rodilla
    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
    Estudio Parte-2 para evaluar la seguridad y la eficacia de JNJ-64179375 frente a Apixaban oral en sujetos sometidos a un reemplazo total de rodilla
    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 & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Cilag, S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917228100
    B.5.5Fax number+34917228628
    B.5.6E-mailagonza45@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.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codeJNJ-64179375
    D.3.9.3Other descriptive nameJNJ-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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 number2.5
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    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
    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
    Tromboembolismo en sujetos que hayan sido sometidos a remplazo total de rodilla unilateral primario electivo
    E.1.1.1Medical condition in easily understood language
    Prevention of forming a blood clot following surgery for replacement of the knee
    Prevención en la formación de coágulos de sangre después de cirugía para reemplazo de rodilla
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    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: El objetivo principal es evaluar la seguridad y la tolerabilidad de JNJ-64179375 en cada nivel de dosis durante el incremento escalonado de la dosis en la parte 1 y los acontecimientos hemorrágicos (la combinación de acontecimientos hemorrágicos graves, acontecimientos hemorrágicos no graves clínicamente relevantes y acontecimientos hemorrágicos mínimos) para la selección de las dosis para la parte 2.

    Parte 2: El objetivo principal es evaluar la respuesta de eficacia a la dosis de JNJ-64179375 para la prevención de la TEV total (TVP proximal y/o distal [asintomática confirmada mediante flebografía de la pierna operada o sintomática confirmada de manera objetiva], la EP no mortal o cualquier muerte).
    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:
    • Evaluar la respuesta a la dosis de JNJ-64179375 en relación con la incidencia del criterio de valoración combinado de cualquier acontecimiento hemorrágico, el criterio de valoración combinado de acontecimientos hemorrágicos graves o no graves clínicamente relevantes y los componentes
    • Evaluar la respuesta a la dosis de JNJ-64179375 en relación con la prevención del tromboembolismo venoso total (TEV) y los componentes individuales de la TEV total
    Parte 2:
    • Evaluar la dosis-respuesta de JNJ-64179375 en relación con la incidencia del criterio de valoración combinado de cualquier acontecimiento hemorrágico, el criterio de valoración combinado de acontecimientos hemorrágicos graves o no graves clínicamente relevantes y los componentes individuales del criterio de valoración combinado de cualquier acontecimiento hemorrágico

    Ver protocolo para más objetivos secundarios comunes de la Parte 1 y Parte 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
    - Varones o mujeres sin capacidad de procrear
    - De al menos 50 o más años de edad
    - Peso ≥ 40 kg a ≤ 150 kg
    - Médicamente adecuados para profilaxis anticoagulante postoperatoria
    - Haberse sometido a ATR unilateral primaria programada
    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
    - Cualquier circunstancia o enfermedad en la que no se recomiende el uso de apixaban en opinión del investigador
    - Procedimiento bilateral, de revisión o unicompartimental
    - Certeza o sospecha de hipersensibilidad o intolerancia a cualquier fármaco biológico o alergias conocidas o reacciones clínicamente importantes a proteínas murinas, quiméricas o humanas, anticuerpos monoclonales o fragmentos de anticuerpos, o a alguno de los excipientes de JNJ-64179375
    - Incapacidad para someterse a una flebografía
    - TVP previa confirmada en una de las extremidades inferiores
    - Cualquier procedimiento invasivo programado de antemano (p. ej., cirugía, colonoscopia) hasta la semana 18 para el que deba interrumpirse el tratamiento anticoagulante o antiagregante plaquetario
    - Uso previsto de compresión neumática intermitente después de la aleatorización
    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.
    Los criterios de valoración del estudio serán los mismos en las partes 1 y 2, pero el centro de interés de la parte 1 será primordialmente el incremento escalonado de la dosis basado en la seguridad, mientras que el centro de interés de la parte 2 será primordialmente la evaluación de la respuesta a la dosis en la seguridad y la eficacia.Criterios de valoración comunes en partes 1 y 2

    Criterios de valoración comunes en las partes 1 y 2

    Criterio de valoración principal de la seguridad
    El criterio de valoración principal de la seguridad es cualquier acontecimiento hemorrágico definido como la combinación de acontecimientos hemorrágicos graves, no graves clínicamente importantes y mínimos hasta la visita del día 10-14.

    Criterio de valoración principal de la eficacia
    criterio de valoración principal de la eficacia es la TEV total, definida como la combinación de TVP proximal y/o distal (asintomática confirmada mediante flebografía de la pierna operada o sintomática confirmada de manera objetiva), EP no mortal o cualquier muerte hasta la visita del día 10-14.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through the Day 10-14 visit.
    Hasta la visita del día 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
    Criterios de valoración secundarios esenciales
    Los criterios de valoración secundarios esenciales son la evaluación de los criterios de valoración principales hasta la visita de la semana 18 y:
    • Todos los componentes individuales del criterio de valoración principal de la seguridad (hemorragia grave, hemorragia no grave clínicamente importante y hemorragia mínima)
    • Combinación de hemorragia grave y hemorragia no grave clínicamente importante
    • TEV importante, una combinación de TVP proximal (asintomática confirmada mediante flebografía de la pierna operada o sintomática confirmada de manera objetiva), EP no mortal o cualquier muerte
    • Todos los componentes individuales del criterio de valoración principal de la eficacia (es decir, TVP proximal y/o distal [asintomática confirmada mediante flebografía de la pierna operada o sintomática confirmada de manera objetiva], EP no mortal o cualquier muerte)
    • Cualquier complicación de la herida o la articulación la pierna operada
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through the Week 18 visit.
    hasta la visita de la semana 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
    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 concerned13
    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 No
    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
    Czech Republic
    Hungary
    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
    Última visita del último sujeto
    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 state100
    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.
    no está planificado el tratamiento de sujetos con JNJ-64179375 más allá de los planificado en este protcolo. El medicamento del estudio es solo para uso experimental.
    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 Decision2017-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-05
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