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    Summary
    EudraCT Number:2018-004237-32
    Sponsor's Protocol Code Number:70033093THR2001
    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:2020-12-17
    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 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.
    Uno studio randomizzato per valutare la sicurezza e l’efficacia di JNJ-70033093 (BMS-986177) orale rispetto a enoxaparina 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
    Randomized Study to Evaluate the Safety and Efficacy of Oral JNJ-70033093 Versus Enoxaparin in Subjects Undergoing Elective Total Knee Replacement
    Studio randomizzato per valutare la sicurezza e l'efficacia di JNJ-70033093 orale rispetto Enoxaparina nei soggetti sottoposti a intervento elettivo di protesi totale del ginocchio
    A.3.2Name or abbreviated title of the trial where available
    70033093THR2001
    70033093THR2001
    A.4.1Sponsor's protocol code number70033093THR2001
    A.5.4Other Identifiers
    Name:.Number:.
    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 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 number0000000000000
    B.5.5Fax number0000000000000
    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-70033093
    D.3.2Product code [JNJ-70033093]
    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.3.9.1CAS number 1802425-99-5
    D.3.9.2Current sponsor codeJNJ-70033093
    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 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.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, 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.3.9.1CAS number 1802425-99-5
    D.3.9.2Current sponsor codeJNJ-70033093
    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 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.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.3.1Product nameClexane
    D.3.2Product code [Enoxaparin]
    D.3.4Pharmaceutical form Solution for injection
    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 INNENOXAPARINA SODIUM
    D.3.9.1CAS number 9041-08-1
    D.3.9.2Current sponsor codeClexane
    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 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 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
    Tromboembolia in soggetti sottoposti a intervento elettivo di protesi totale del ginocchio
    E.1.1.1Medical condition in easily understood language
    Prevention of forming blood clot following surgery for replacement of the knee
    Prevenzione della formazione di coaguli di sangue dopo l'intervento elettivo di protesi totale 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 21.1
    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.
    Determinare l’efficacia di JNJ-70033093 nella prevenzione degli eventi TEV totali (TVP prossimale e/o distale [asintomatica confermata da un esame flebografico o sintomatica confermata oggettivamente], EP non fatale) e del decesso durante il periodo di trattamento.
    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).
    •Valutare la relazione dose-risposta di JNJ-70033093 relativamente all’occorrenza dell’endpoint degli eventi di sanguinamento di qualsiasi tipo durante il periodo di trattamento
    •Determinare l’efficacia di JNJ-70033093 nella prevenzione degli eventi TEV totali durante lo studio
    •Valutare la relazione dose-risposta di JNJ-70033093 relativamente al tasso di eventi di sanguinamento di qualsiasi tipo durante lo studio
    •Valutare la relazione dose-risposta di JNJ-70033093 per la prevenzione degli eventi TEV maggiori (decesso, TVP prossimale asintomatica o sintomatica o EP) durante il periodo di trattamento durante lo studio
    •Valutare l’effetto delle singole dosi di JNJ-70033093 rispetto all’enoxaparina per entrambi gli endpoint di efficacia e sicurezza
    •Confrontare l’effetto di JNJ-70033093 rispetto all’enoxaparina per i singoli componenti dell’endpoint degli eventi TEV totali
    •Valutare la PK di JNJ-70033093 in pz sottoposti a chirurgia protesica totale del ginocchio unilaterale primaria
    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.

    ogni potenziale soggetto deve soddisfare tutti i seguenti criteri per essere arruolati nello studio:
    1. Uomo o donna.
    2. 50 anni di età, o più anziani.
    3. Clinicamente stabile ed idoneo alla profilassi anticoagulante, secondo il giudizio dello sperimentatore sulla base dell’esame obiettivo, anamnesi e segni vitali eseguiti come parte dello screening per la chirurgia elettiva TKR.
    4. Clinicamente stabile e idoneo alla profilassi anticoagulante in base ai test clinici di laboratorio secondo le procedure locali e come parte dello screening per la chirurgia elettiva TKR. Se i risultati delle analisi di laboratorio sono al di fuori dei normali intervalli di riferimento, il soggetto può essere incluso solo se lo sperimentatore giudica le anomalie o le deviazioni dalla normalità non clinicamente significative oppure essere appropriate e ragionevoli in considerazione della popolazione in studio. Questa valutazione deve essere riportata nella cartella clinica del soggetto e firmata dallo sperimentatore.
    5. Ha in programma di sottoporsi ad un intervento di chirurgia protesica elettiva unilaterale di ginocchio.
    6. Deve firmare un modulo di consenso informato (ICF) dove indica di comprendere lo scopo e le procedure richieste per lo studio ed è disposto a partecipare allo studio.
    7. Le donne potenzialmente fertili (WOCBP) devono avere il test sulle urine negativo oppure il dosaggio della ß gonadotropina corionica umana [ßhCG] negativo fino a 2 giorni prima della somministrazione del farmaco di studio.
    8. Le donne devono:
    • Essere non potezialmente fertili
    • Se fertili, adottare un metodo contraccettivo altamente efficace (tasso di fallimento di < 1% all'anno se utilizzato in modo coerente e corretto) e accettano di continuare ad adottare un metodo altamente efficace per la durata dello studio con JNJ 70033093 più 5 emivite del farmaco in studio, più 30 giorni (durata del ciclo ovulatorio), per un totale di 32 a giorni dopo il completamento del trattamento.
    • Effettuare un test di gravidanza (su siero o urina) prima di assumere la prima dose del farmaco dello studio.
    9. Le donne deve accettare di non donare ovuli e ovociti ai fini della riproduzione assistita durante lo studio e per un periodo di 32 a giorni dopo l’ultima dose.
    10. Gli uomini deve utilizzare un preservativo quando si impegnano in qualsiasi attività con un WOCBP durante lo studio e per la durata del trattamento con JNJ-70033093, più 5 emivite del farmaco di studio, più 90 giorni (durata del turnover dello sperma), per un totale di 92 giorni dopo il completamento del trattamento. I soggetti di sesso maschile dovrebbero anche essere informati del beneficio per una partner femminile di utilizzare un metodo di contraccezione altamente efficace in relazione alla possibile rottura o perdita del preservativo. Questo criterio non si applica ai soggetti maschi assegnati a caso all’enoxaparina.
    11. Gli uomini devono accettare di non donare sperma allo scopo della riproduzione durante lo studio e per la durata del trattamento con JNJ-70033093, più 5 emivita del farmaco di studio, più 90 giorni (durata del turnover dello sperma), per un totale di 92 giorni dopo il completamento del trattamento. Questo criterio non si applica ai soggetti maschi assegnati a caso a enoxaparina.
    12. Essere in grado di aderire alle restrizioni di stile di vita specificate nel protocollo.
    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.
    Qualsiasi soggetto che soddisfi uno dei seguenti criteri sarà escluso dalla partecipazione allo studio:
    1. Anamnesi di qualsiasi condizione per cui l'uso di LMWH non è raccomandato secondo il parere dello sperimentatore (ad esempio: precedente reazione allergica, clearance della creatinina < 30 mL/minuto).
    2. Insufficienza epatica severa in anamnesi.
    3. Procedura programmata di revisione bilaterale o unicompartimentale.
    4. L'analgesia epidurale postoperatoria pianificata con un catetere epidurale.
    • Se è stato usato un catetere epidurale, deve essere rimosso almeno 5 ore prima della sommistrazione postoperatoria del farmaco in studio.
    • Se le dosi preoperatorie di JNJ-70033093 vengono introdotte a seguito dell'analisi ad interim, tutti i soggetti possono essere randomizzati solo se è previsto un blocco nervoso e/o un'anestesia generale.
    Nota: Se un soggetto randomizzato sottoposto ad un’anestasia epidurale o spinale ha avuto sanguinamento o un trauma significativo al momento dell'intervento chirurgico, non deve assumere il farmaco in studio.
    5. Non può sottoporsi alla flebografia (ad esempio, a causa dell’allergia all’agente di contrasto, scarso accesso venoso, o compromissione della funzione renale che aumenterebbe il rischio di neuropatia indotta da contrasto).
    6. Nota precedente PE o DVT in entrambi gli arti inferiori.
    7. Note allergie, ipersensibilità o intolleranza al JNJ-70033093 o agli eccipienti (fare riferimento all’Investigator’s Brochure).
    8. Concondicazioni all'uso di enoxaparina o allergie note, ipersensibilità o intolleranza all’enoxaparina sodica secondo le indicazioni locali.
    9. Qualsiasi condizione che richieda una terapia antitrombotica cronica (ad esempio fibrillazione atriale, valvola cardiaca meccanica, recente intervento coronarico), ad eccezione dell'aspirina minore o uguale a100 mg al giorno.
    10. Uso di potenti inibitori del CYP3A4 / P-gp o forti induttore del CYP3A4/P-gp nei 7 giorni precedenti la randomizzazione o necessità di un trattamento in corso con concomitante terapia orale o IV con forti inibitori del CYP3A4 / P-gp o forte CYP3A4 / Induttori della P-gp durante il periodo di trattamento.
    11. Assunzione di terapie non consentite come indicato nella Sezione 6.5, Terapia concomitante prima della prevista prima dose di farmaco in studio del protocollo.
    12. Previsto ricorso alla compressione pneumatica intermittente dopo la prima dose postoperatoria del farmaco in studio.
    13. Ha ricevuto un farmaco in studio sperimentale (compresi i vaccini sperimentali) o ha utilizzato un dispositivo medico sperimentale invasivo nei 60 giorni antecedenti la prima dose di farmaco in studio o è attualmente arruolato in uno studio sperimentale.
    14. Qualsiasi condizione per cui a giudizio dello sperimentatore, la partecipazione non è nel miglior interesse del soggetto (ad esempio può comprometterne il benessere) o che potrebbe impedire, limitare o confondere le valutazioni specificate nel protocollo.
    15. Ha pianificato un intervento chirurgico (eccetto per lo studio TKR) nel periodo in cui è previsto che il soggetto partecipi allo studio per il quale la terapia anticoagulante verrebbe interrotta.
    16. Soggetti precedentemente randomizzati in questo studio o che hanno partecipato a precedenti studi con JNJ 70033093.
    17. Dipendente dello sperimentatore o del centro sperimentale, con coinvolgimento diretto nello studio proposto o in altri studi sotto la direzione di questi, nonché dei familiari dei dipendenti o dello sperimentatore.
    18. Al momento del consenso informato, il soggetto non accetta di seguire le visite di studio programmate o di consentire un contatto telefonico ai mezzi di contatto alternativi del soggetto (ad es. figli, coniuge, altro significativo, custode, rappresentante legale, operatore sanitario ), se necessario, fino alla fine dello studio, se interrompe 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.
    Eventi TEV totali durante il periodo di trattamento fino alla data della flebografia, secondo la valutazione del CEC. La prova di efficacia sarà ottenuta se si potrà dimostrare una relazione dose-risposta positiva o se si avrà un tasso di eventi TEV totali inferiore al 30% nel gruppo delle dosi combinate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through week 6
    fino alla Settimana 6
    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 bleeding according to the ISTH criteria modified for the surgical setting, clinically relevant nonmajor bleeding events, or minimal bleeding events as assessed by the CEC.; 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 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.
    Endpoint composito degli eventi di sanguinamento di qualsiasi tipo occorsi durante il trattamento.
    Gli eventi di sanguinamento di qualsiasi tipo saranno definiti come l’insieme costituito dagli eventi di sanguinamento maggiori, in accordo ai criteri ISTH modificati secondo l'impostazione chirurgica, insieme agli eventi di sanguinamento non maggiori clinicamente rilevanti e gli eventi di sanguinamento minimi valutati dal CEC.; Eventi TEV totali valutati dal CEC fino alla Settimana 6; 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 valutati dal CEC fino alla Settimana 6.; Eventi TEV maggiori valutati dal CEC durante il periodo di trattamento e fino alla Settimana 6; Eventi TEV totali ed eventi di sanguinamento di qualsiasi tipo valutati dal CEC durante il periodo di trattamento e durante l’intero periodo dello studio (6 settimane).; Tutti i singoli componenti dell’endpoint di efficacia primario valutati dal CEC durante il periodo di trattamento e durante l’intero periodo dello studio (6 settimane).; Stima dei parametri PK e degli effetti demografici e dei valori di laboratorio (ad es. Peso corporeo, età, genere, funzione renale) sulla PK di JNJ 70033093.
    Stima della relazione tra i livelli di esposizione di JNJ-70033093, la probabilità di eventi TEV totali durante il periodo di trattamento fino al momento della flebografia, la probabilità dell’endpoint composito degli eventi di sanguinamento maggiori o non maggiori clinicamente rilevanti e i singoli componenti dell’endpoint composito degli eventi di sanguinamento di qualsiasi tipo occorsi durante il trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through week 6 ; Through week 6; through Week 6.; through Week 6.; during the full study period (6 weeks); during the full study period (6 weeks).; during the full study period (6 weeks)
    fino alla Settimana 6; fino alla Settimana 6; fino alla Settimana 6; fino alla Settimana 6; durante l’intero periodo dello studio (6 settimane).; durante l’intero periodo dello studio (6 settimane).; durante l’intero periodo dello studio (6 settimane).
    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 trial7
    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 concerned7
    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 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
    United States
    Belgium
    Bulgaria
    Czechia
    Hungary
    Latvia
    Lithuania
    Poland
    Spain
    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
    Ultima visita dell'ultimo paziente (LPLV)
    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 days12
    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: 511
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 689
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 513
    F.4.2.2In the whole clinical trial 1200
    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.
    non è previsto alcun trattamento con JNJ-70033093 al termine dello studio
    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 Decision2019-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-06
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