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    Summary
    EudraCT Number:2018-004237-32
    Sponsor's Protocol Code Number:70033093THR2001
    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:2019-07-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-004237-32
    A.3Full title of the trial
    A Randomized, Open-Label, Study Drug-Dose Blind, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-70033093 (BMS-986177), an Oral Factor XIa Inhibitor, Versus Subcutaneous Enoxaparin in Subjects Undergoing Elective Total Knee Replacement Surgery.
    Estudio aleatorizado, abierto, multicéntrico, ciego para la dosis, para evaluar la eficacia y seguridad de JNJ-70033093 (BMS-986177), un inhibidor oral del factor XIa, frente a enoxaparina subcutánea en sujetos sometidos a cirugía programada de reemplazo total de rodilla.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized Study to Evaluate the Safety and Efficacy of Oral JNJ-70033093 Versus Enoxaparin in Subjects Undergoing Elective Total Knee Replacement
    Estudio aleatorizado para evaluar la eficacia y seguridad de JNJ-70033093 (BMS-986177) frente a enoxaparina subcutánea en sujetos sometidos a cirugía programada de reemplazo total de rodilla.
    A.4.1Sponsor's protocol code number70033093THR2001
    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
    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 number34917228100
    B.5.5Fax number34917228624
    B.5.6E-mailcsimal@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-70033093
    D.3.2Product code JNJ-70033093
    D.3.4Pharmaceutical form Capsule
    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 INNNot applicable
    D.3.9.1CAS number 1802425-99-5
    D.3.9.2Current sponsor codeJNJ-70033093
    D.3.9.3Other descriptive nameBMS986177
    D.3.9.4EV Substance CodeSUB179265
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ-70033093
    D.3.2Product code JNJ-70033093
    D.3.4Pharmaceutical form Capsule
    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 INNNot applicable
    D.3.9.1CAS number 1802425-99-5
    D.3.9.2Current sponsor codeJNJ-70033093
    D.3.9.3Other descriptive nameBMS986177
    D.3.9.4EV Substance CodeSUB179265
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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.IMP: 3
    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 Clexane
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    D.2.1.2Country which granted the Marketing AuthorisationRomania
    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 Solution for injection in pre-filled syringe
    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.3.8INN - Proposed INNENOXAPARIN SODIUM
    D.3.9.1CAS number 9041-08-1
    D.3.9.4EV Substance CodeSUB11933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboCapsule
    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 sometidos a cirugía programada de reemplazo total de rodilla.
    E.1.1.1Medical condition in easily understood language
    Prevention of forming blood clot following surgery for replacement of the knee
    Prevención de formación de coágulos sanguíneos después de la cirugía de reemplazo de rodilla.
    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 LLT
    E.1.2Classification code 10066899
    E.1.2Term Venous thromboembolism
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of JNJ-70033093 in preventing total VTE events (proximal and/or distal DVT [asymptomatic confirmed by venography assessment or objectively confirmed symptomatic], nonfatal PE), or any death during the treatment period.
    Determinar la eficacia de JNJ-70033093 en la prevención de acontecimientos de TEV total (TVP proximal y/o distal [asintomática confirmada por evaluación venográfica o confirmada objetivamente por los síntomas], EP no mortal), o de cualquier fallecimiento que se produzca durante el período de tratamiento.
    E.2.2Secondary objectives of the trial
    To assess the dose response of JNJ-70033093 for the occurrence of the endpoint of any bleeding events during the treatment period.
    To determine the efficacy of JNJ-70033093 in preventing total VTE events during the full study period.
    To assess the dose response of JNJ-70033093 for the rate of any bleeding throughout the full study period.
    To assess the dose response of JNJ-70033093 for the prevention of major VTE (death, asymptomatic or symptomatic proximal DVT or PE) during the treatment period and throughout the full study period.
    To assess the effect of individual doses of JNJ 70033093 compared with enoxaparin for both efficacy and safety endpoints.
    To compare the effect of JNJ-70033093 with enoxaparin for the individual components of the total VTE endpoint.
    To assess the PK of JNJ-70033093 in men and women undergoing primary unilateral TKR surgery and the relation of these measures to efficacy and safety endpoints (eg, exposure-response analyses).
    Evaluar la respuesta a la dosis de JNJ-70033093 para la aparición del criterio de valoración de cualquier acontecimiento hemorrágico durante el período de tratamiento.
    Determinar la eficacia de JNJ-70033093 en la prevención de acontecimientos de TEV total durante todo el período del estudio.
    Evaluar la respuesta de la dosis de JNJ-70033093 para la tasa de hemorragias durante todo el período del estudio.
    Evaluar la respuesta a la dosis de JNJ-70033093 para la prevención de TEV importante (muerte, TVP o EP proximal asintomática o sintomática) durante el período del tratamiento y durante todo el período del estudio.
    Evaluar el efecto de dosis individuales de JNJ-70033093 en comparación con enoxaparina, tanto para los criterios de valoración de eficacia como para los de seguridad.
    Comparar el efecto de JNJ-70033093 con enoxaparina para los componentes individuales del criterio de valoración de TEV total.
    Para más información, por favor consultar página dos de resumen de protocolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female.
    50 years of age, or older.
    Medically stable and appropriate for anticoagulant prophylaxis as determined by the investigator on the basis of physical examination, medical history, and vital signs performed as part of screening for elective TKR surgery.
    Medically stable and appropriate for anticoagulant prophylaxis on the basis of clinical laboratory tests performed as part of local standard-of-care as part of screening for elective TKR surgery. If the results of laboratory tests are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject’s source documents and initialed by the investigator.
    Has plans to undergo an elective primary unilateral TKR surgery.
    Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    A woman of childbearing potential (WOCBP) must have a negative urine or highly sensitive serum (Beta human chorionic gonadotropin) up to 2 days before the administration of the study drug.
    A woman must be (as defined in the protocol Section 10.5, Appendix 5, Contraceptive and Barrier Guidance and Collection of Pregnancy Information).
    a. Not of childbearing potential
    b. Of childbearing potential and
    o Practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to remain on a highly effective method for the duration of study drug with JNJ 70033093 plus 5 half-lives of study drug plus 30 days (duration of ovulatory cycle) for a total of 32 days after the completion of treatment. Examples of highly effective methods of contraception are located in Section 10.5, Appendix 5, Contraceptive and Barrier Guidance and Collection of Pregnancy Information.
    o Pregnancy testing (serum or urine) prior to the first dose of study drug.
    A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 32 days after the last dose.
    A male subject must wear a condom when engaging in any activity with a WOCBP during the study and for the duration of treatment with JNJ-70033093 plus 5 half-lives of the study drug plus 90 day (duration of sperm turnover) for a total of 92 days after the completion of treatment. Male subjects should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak. This criterion does not apply to male subjects randomly assigned to enoxaparin.
    A male subject must agree not to donate sperm for the purpose of reproduction during the study and for the duration of treatment with JNJ-70033093 plus 5 half-lives of the study drug plus 90 days (duration of sperm turnover) for a total of 92 days after the completion of treatment. This criterion does not apply to male subjects randomly assigned to enoxaparin.
    Willing and able to adhere to the lifestyle restrictions (Section 5.3, Lifestyle Considerations) specified in this protocol.
    Varón o mujer.
    50 años de edad o más.
    Médicamente estable y apto para la profilaxis con anticoagulantes según lo determinado por el investigador en función de la exploración física, la historia clínica y las constantes vitales obtenidas como parte de la selección para la cirugía de RTR programada.
    Médicamente estable y apto para la profilaxis con anticoagulantes en función de las pruebas de laboratorio clínico realizadas como parte del estándar de atención médica local y del proceso de selección para la cirugía de RTR programada. Si los resultados de las pruebas del laboratorio están fuera de los intervalos de referencia normales, el sujeto puede ser inscrito, siempre que el investigador juzgue que las anomalías o desviaciones de la normalidad no son clínicamente significativas o que son adecuadas y razonables para la población del estudio. Esta determinación debe registrarse en los documentos originales del sujeto y el investigador debe añadir sus iniciales.
    Tiene planes de someterse a una intervención quirúrgica de RTR primaria unilateral.
    Debe firmar un formulario de consentimiento informado (FCI) que indique que entiende el propósito y los procedimientos requeridos para el estudio y que está dispuesto a participar en mismo.
    Una mujer fértil debe dar negativo en un análisis de embarazo en orina o en suero de alta sensibilidad (╬▓gonadotropina coriónica humana [╬▓-hCG]) hasta 2 días antes de la administración del fármaco del estudio.
    Las mujeres deben satisfacer los siguientes requisitos (según se define en la Sección 10.5, Apéndice 5, Directrices de anticoncepción y barrera y recopilación de información sobre el embarazo).
    a. No fértiles, o
    b. Fértiles pero:
    o Practican un método anticonceptivo altamente efectivo (tasa de fallos de < 1 % por año cuando se usa de forma sistemática y correcta) y aceptan seguir practicándolo mientras sigan tomando el fármaco del estudio JNJ-70033093, más 5 semividas del fármaco del estudio, más 30 días (duración del ciclo ovulatorio) para un total de 32 días una vez finalizado el tratamiento. Algunos ejemplos de métodos anticonceptivos altamente efectivos se detallan en la Sección 10.5, Apéndice 5, Directrices de anticoncepción y barrera y recopilación de información sobre el embarazo.
    o Pruebas de embarazo (en suero u orina) antes de recibir la primera dosis del fármaco del estudio.
    Las mujeres deben comprometerse a no donar óvulos (ovocitos) con fines de reproducción asistida durante el estudio y durante un período de 32 días después de tomar la última dosis.
    Los sujetos varones debe utilizar un preservativo cuando mantengan cualquier actividad sexual con una mujer fértil durante el estudio y durante el tratamiento con JNJ-70033093, más 5 semividas del fármaco del estudio, más 90 días (duración de la regeneración del esperma) para un total de 92 días una vez finalizado el tratamiento. Los sujetos varones también deben ser informados de que su pareja femenina debe usar un método anticonceptivo altamente eficaz, ya que el preservativo podría romperse o tener fugas. Este criterio no se aplica a sujetos varones asignados al azar a enoxaparina.
    Los sujetos varones deben comprometerse a no donar esperma con fines reproductivos durante el estudio y durante todo el tratamiento con JNJ-70033093, más 5 semividas del fármaco del estudio, más 90 días (duración de la regeneración del esperma) para un total de 92 días una vez finalizado el tratamiento. Este criterio no se aplica a sujetos varones asignados al azar a enoxaparina.
    Deben comprometerse a cumplir con las restricciones de estilo de vida (Sección 5.3, Consideraciones sobre el estilo de vida) especificadas en este protocolo.
    E.4Principal exclusion criteria
    History of any condition for which the use of LMWH is not recommended in the opinion of the investigator (eg, previous allergic reaction, creatinine clearance <30 mL/minute).
    History of severe hepatic impairment.
    Planned bilateral revision or unicompartmental procedure.
    Planned postoperative epidural analgesia with an epidural catheter.
    • If an epidural catheter was used, it must be removed at least 5 hours prior to postoperative study drug administration.
    • If preoperative doses of JNJ-70033093 are implemented following the interim analysis, all subjects may only be randomized if a nerve block and/or general anesthesia is planned.
    Unable to undergo venography (eg, due to contrast agent allergy, poor venous access, or impaired renal function that would increase the risk of contrast-induced neuropathy.
    Known previous PE or DVT in either lower extremity.
    Known allergies, hypersensitivity, or intolerance to JNJ-70033093 or its excipients (refer to IB).
    Contraindications to the use of or known allergies, hypersensitivities, or intolerance to enoxaparin per local prescribing information.
    Any condition requiring chronic antithrombotic therapy (eg, atrial fibrillation, mechanical heart valve, recent coronary intervention), except for aspirin less than or equal to 100 mg per day.
    Use of strong CYP3A4/P-gp inhibitors or strong CYP3A4/P-gp inducers in the 7 days prior to randomization or the need for ongoing treatment with concomitant oral or IV therapy with strong CYP3A4/P-gp inhibitors or strong CYP3A4/P-gp inducers during the treatment period.
    Taken any disallowed therapies as noted in the protocol Section 6.5, Concomitant Therapy before the planned first dose of study drug.
    Planned use of intermittent pneumatic compression after the first postoperative dose of the study drug.
    Received an investigational study drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the planned first dose of study drug or is currently enrolled in an investigational study.
    Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    Has surgery planned (except the TKR study) during the time the subject is expected to participate in the study for which anticoagulant therapy would be interrupted.
    Previously randomized subject in this study or participated in previous studies with JNJ 70033093.
    Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
    At the time of informed consent, the subject does not agree to following up with scheduled study visits or allowing a telephone contact to the subject’s alternative means of contact (eg subject’s children, spouse, significant other, caretaker, legal representative, healthcare professional), as necessary, until the end of the study, should he or she discontinue prematurely.
    Antecedentes de cualquier afección para la cual, y opinión del investigador, se desaconseje el uso de heparina de bajo peso molecular (p. ej., antecedentes de reacción alérgica previa, aclaramiento de creatinina < 30 ml/minuto).
    Antecedentes de insuficiencia hepática grave.
    Procedimiento planeado de revisión bilateral o unicompartimental.
    Analgesia epidural posoperatoria con catéter epidural programada.
    • Si se utilizó un catéter epidural, debe retirarse al menos 5 horas antes de la administración posoperatoria del fármaco del estudio.
    • Si las dosis preoperatorias de JNJ-70033093 se administran después del análisis intermedio, todos los sujetos solo podrán ser aleatorizados si hay programado un bloqueo nervioso y/o anestesia general.
    No pueden someterse a una venografía (por ejemplo, debido a una alergia al agente de contraste, a un acceso venoso deficiente o a una insuficiencia renal que pudiera aumentar el riesgo de neuropatía inducida por el medio de contraste).
    EP o TVP previas confirmadas en alguna de las extremidades inferiores.
    Alergias, hipersensibilidad o intolerancia conocidas a JNJ-70033093 o a sus excipientes (consultar el manual del investigador).
    Contraindicaciones para el uso o alergias, hipersensibilidades o intolerancias conocidas, o intolerancia a la enoxaparina según la información la información de la prescripción local.
    Cualquier enfermedad que requiera terapia antitrombótica crónica (p. ej., fibrilación auricular, válvula cardíaca mecánica, intervención coronaria reciente), excepto aspirina, ≤ 100 mg al día.
    Uso de inhibidores potentes del CYP3A4/P-gp o inductores potentes del CYP3A4/P-gp en los 7 días previos a la aleatorización o necesidad de un tratamiento concomitante oral o IV continuado con inhibidores potentes del CYP3A4/P-gp o inductores potentes del CYP3A4/P durante el tratamiento.
    Han recibido alguno de los tratamientos no permitidos que se indican en la Sección 6.5, Tratamientos concomitantes, antes de recibir la primera dosis programada del fármaco del estudio.
    Uso programado de la compresión neumática intermitente después de recibir la primera dosis posoperatoria del fármaco del estudio.
    Han tomado un fármaco de un estudio de investigación (incluidas vacunas experimentales) han usado un dispositivo médico invasivo en investigación en los 60 días anteriores a la primera dosis programada del fármaco del estudio, o están actualmente inscritos en un estudio de investigación.
    Cualquier enfermedad para la cual, en opinión del investigador, la participación no redunde en el mejor interés del sujeto (por ejemplo, que ponga en peligro su bienestar) o que pudiera evitar, limitar o confundir las evaluaciones especificadas en el protocolo.
    Hay una intervención quirúrgica programada (excepto la RTR del estudio) durante el tiempo que se espera que el sujeto participe en el estudio, para la cual fuera necesario interrumpir la terapia anticoaguladora.
    El sujeto ha sido previamente asignado al azar en este estudio o ha participado en anteriores estudios con JNJ-70033093.
    Empleados del investigador o del centro del estudio, con participación directa en el estudio propuesto o en otros estudios bajo la dirección de ese investigador o centro del estudio, así como familiares de los empleados o del investigador.
    En el momento de la firma del consentimiento informado, el sujeto no está de acuerdo con el seguimiento de las visitas programadas del estudio ni en permitir el contacto telefónico con medios alternativos de contacto del sujeto (por ejemplo, los hijos del sujeto, su cónyuge, su pareja, el cuidador, el representante legal, un profesional de la medicina) cuando sea necesario y hasta el final del estudio, si el sujeto abandona el estudio prematuramente.
    E.5 End points
    E.5.1Primary end point(s)
    Total VTE during the treatment period up to the time of venography as assessed by the CEC. Proof-of-efficacy is reached by either showing a positive dose response or having less than a 30% total VTE event rate in the combined dose group.
    TEV total durante el período de tratamiento hasta el momento de la venografía según la evaluación del CAC. La prueba de eficacia se logra al mostrar una respuesta positiva a la dosis o al lograr una tasa de acontecimientos de TEV total inferior al 30 % en el grupo de dosis combinado.
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    E.5.2Secondary end point(s)
    The composite endpoint of any bleeding event on treatment. Any bleeding will be defined as the composite of major, clinically relevant nonmajor bleeding events, or minimal bleeding events accessed by the CEC. Major and clinically relevant nonmajor bleeding events will be assessed according to the ISTH criteria modified for the surgical setting.
    Total VTE as assessed by the CEC through Week 6.
    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 as assessed by the CEC through Week 6.
    Major VTE as assessed by the CEC during the treatment period and through Week 6.
    Total VTE and any bleeding as assessed by the CEC during the treatment period and during the full study period (6 weeks).
    All individual components of the primary efficacy endpoint as assessed by the CEC during the treatment period and during the full study period (6 weeks).
    Estimation of PK parameters and the effects of demographics and laboratory values (eg, body weight, age, gender, renal function) on the PK of JNJ 70033093.
    Estimation of the relationship between JNJ 70033093 exposure levels with probability of total VTE during the treatment period up to the time of venography and the probability of the composite endpoint of major or clinically relevant nonmajor bleeding events, and the individual components of the composite endpoint of any bleeding event on treatment.
    El criterio de valoración compuesto de cualquier acontecimiento hemorrágico en el tratamiento. Cualquier hemorragia se definirá como la combinación de acontecimientos hemorrágicos importantes, no importantes pero clínicamente relevantes, o mínimos, conocidos por el CAC. Los acontecimientos hemorrágicos importantes y los no importantes pero clínicamente relevantes se evaluarán de acuerdo a los criterios de la Sociedad Internacional de Trombosis y Hemostasia (ISTH) modificados para el entorno quirúrgico.
    VTE total según la evaluación del CAC hasta la semana 6.
    Aparición del criterio de valoración combinado de cualquier evento hemorrágico, el criterio de valoración combinado de acontecimientos hemorrágicos importantes, o no importantes pero clínicamente relevantes, y los componentes individuales del criterio de valoración combinado de cualquier hemorragia según la evaluación del CAC hasta la Semana 6.
    VTE importante según la evaluación del CAC durante el período de tratamiento y hasta la semana 6.
    TEV total y cualquier hemorragia según la evaluación del CAC durante el período de tratamiento y durante todo el período del estudio (6 semanas).
    Todos los componentes individuales del criterio de valoración de eficacia principal según la evaluación del CAC durante el período de tratamiento y durante todo el período del estudio (6 semanas).
    Estimación de los parámetros de FC y de los efectos de los valores demográficos y analíticos (p. ej., peso corporal, edad, sexo, función renal) en la FC de JNJ-70033093.
    Estimación de la relación entre los niveles de exposición de JNJ-70033093 y la probabilidad de TEV total durante el período de tratamiento hasta el momento de la venografía, así como la probabilidad del criterio de valoración combinado de acontecimientos hemorrágicos importantes, o no importantes pero clínicamente relevantes, y los componentes individuales del criterio de valoración combinado de cualquier acontecimiento hemorrágico durante el tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial9
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    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
    last subject last visit
    Última visita último paciente
    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 months9
    E.8.9.1In the Member State concerned days23
    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 days12
    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: 637
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 863
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 544
    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-70033093 any further than scheduled in this study protocol. The study drug is for experimental use only.
    No está previsto tratar a los sujetos con JNJ-70033093 más allá de lo programado en este protocolo de estudio. El fármaco de estudio es sólo 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 Decision2019-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-06
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