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    Summary
    EudraCT Number:2015-000962-76
    Sponsor's Protocol Code Number:17992
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-22
    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 number2015-000962-76
    A.3Full title of the trial
    Single-dose study testing a rivaroxaban granules for oral suspension formulation in children from 2 months to 12 years with previous thrombosis
    Studio a dose singola per la valutazione di¿¿rivaroxaban nella formulazione in granuli per sospensione orale in bambini da 2 mesi a 12 anni d¿et¿ colpiti da una precedente trombosi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Single-dose study testing a rivaroxaban granules to be diluted into an oral suspension in children from 2 months to 12 years with previous blood clot
    Studio di Fase I su rivaroxaban granulato da diluire in sospensione orale per bambini
    A.3.2Name or abbreviated title of the trial where available
    Phase 1 granules for oral suspension
    Granules for oral suspension fase 1
    A.4.1Sponsor's protocol code number17992
    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 SponsorBAYER AG
    B.1.3.4CountryUnited States
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical trials contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP team/ref:"EU CTR"/Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number000
    B.5.5Fax number000
    B.5.6E-mailclinical-trials-contact@bayer.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 nameXarelto
    D.3.2Product code BAY59-7939
    D.3.4Pharmaceutical form Granules for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.2Current sponsor codeBAY59-7939
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Thrombosis
    Trombosi
    E.1.1.1Medical condition in easily understood language
    Blood Clot
    Coaguli nel sangue
    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 PT
    E.1.2Classification code 10043607
    E.1.2Term Thrombosis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ¿ To characterize the pharmacokinetic profile of rivaroxaban administered as granules for oral suspension formulation
    ¿ Caratterizzare il profilo farmacocinetico di rivaroxaban somministrato sotto forma di granulato per sospensione orale
    E.2.2Secondary objectives of the trial
    ¿ To document safety and tolerability in terms of AEs observed after administration of the rivaroxaban granules for oral suspension formulation
    ¿ Documentare la sicurezza e la tollerabilit¿ in termini di eventi avversi osservati dopo somministrazione di rivaroxaban in formulazione di granuli per sospensione orale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For group A and B
    1.Children with an age between 6 months and <12 years who
    have completed anticoagulant treatment at least 10 days prior
    to the planned study drug administration.
    For Group C:
    Children with an age =2 months and weight between 3 and <12 kg, who
    have
    completed anticoagulant treatment at least 10 days prior to the planned
    study
    drug administration.
    ¿ Gestational age at birth of at least 37 weeks
    ¿ Oral feeding/ nasogastric/ gastric feeding for at least 10 days 29
    For groups A, B and C:
    2. Normal prothrombin time (PT) and activated partial
    thromboplastin time (aPTT) within 10 days prior to planned
    study drug administration
    3. Written informed consent provided and, if applicable, child
    assent provided
    Per gruppo A e B:
    1. Bambini di età compresa fra 6 mesi e <12 anni che abbiano completato il trattamento anticoagulante almeno 10 giorni prima della somministrazione programmata del farmaco in studio
    Per il Gruppo C:
    Bambini di età = 2 mesi e peso compreso fra 3 kg e < 12 kg che hanno portato a termine il trattamento anticoagulante almeno 10 giorni prima della somministrazione pianificata del farmaco in studio e presentano
    • età gestazionale alla nascita di almeno 37 settimane e
    • alimentazione orale/alimentazione nasogastrica/gastrica per almeno 10 giorni
    Per gruppi A, B e C
    2. Tempo di protrombina (PT) e tempo di tromboplastina parziale attivata (aPTT) normale entro 10 giorni prima della somministrazione programmata del farmaco in studio
    3. Consenso informato scritto fornito e, se applicabile, assenso fornito dal bambino
    E.4Principal exclusion criteria
    For groups A, B and C:
    1.Active bleeding or high risk for bleeding, contraindicating
    anticoagulant therapy
    2. Planned invasive procedures, including removal of central
    lines, within 24 hours before and after single dose intake
    3. An estimate glomerular filtration rate (eGFR)
    < 30 mL/min/1.73m2
    4. Hepatic disease which is associated either with: coagulopathy
    leading to a clinically relevant bleeding risk, or ALT > 5x upper level of normal (ULN), or
    total bilirubin > 2x ULN with direct bilirubin > 20% of the
    total
    5. Platelet count < 50 x 109/L
    6. Hypertension defined as systolic and/or diastolic blood
    pressure >95th percentile for age)
    7. Concomitant use of strong inhibitors of both CYP3A4 and
    P-glycoprotein, e.g., all human immunodeficiency virus
    protease inhibitors and the following azole-antimycotic
    agents: ketoconazole, itraconazole, voriconazole, and
    posaconazole, if used systemically (fluconazole is allowed)
    8. Concomitant use of strong inducers of CYP3A4, e.g.,
    rifampicin, rifabutin, phenobarbital, phenytoin and
    carbamazepine
    9. Inability to cooperate with the study procedures
    10. Hypersensitivity to rivaroxaban
    11. Participation in a study with an investigational drug other than
    rivaroxaban or a medical device within 30 days prior to
    treatment
    For group C only:
    12. history of gastrointestinal disease or surgery associated with impaired absorption
    Per gruppi A, B e C:
    1. Emorragia in atto o rischio elevato di emorragia, che rappresenti una controindicazione alla terapia anticoagulante
    2. Procedure invasive programmate comprendenti la rimozione delle linee centrali entro 24 ore prima e dopo l’assunzione della dose singola
    3. Filtrazione glomerulare stimata (eGFR) <30 mL/min/1,73m2 calcolata secondo la formula di Cockcroft-Gault
    4. Malattia epatica associata a coagulopatia che comporti un rischio emorragico clinicamente rilevante o un livello di ALT > 5 volte il livello superiore della norma (ULN) o bilirubina totale > 2 volte il limite superiore di norma (ULN) con bilirubina diretta > 20% del totale
    5. Conta piastrinica < 50 x 109/L
    6. Ipertensione definita come pressione arteriosa sistolica e/o diastolica >95° percentile per l’età)
    7. Impiego concomitante di forti inibitori sia di CYP3A4 che della P glicoproteina ad esempio tutti gli inibitori della proteasi del virus dell’immunodeficienza umana e dei seguenti antimicotici azolici: ketoconazolo, itraconazolo, voriconazolo e posaconazolo, se usati per via sistemica (il fluconazolo è consentito)
    8. Impiego concomitante di forti induttori di CYP3A4, ad esempio rifampicina, rifabutina, fenobarbitale, fenitoina e carbamazepina
    9. Incapacità a collaborare con le procedure dello studio
    10. Ipersensibilità al rivaroxaban
    11. Partecipazione ad uno studio con un farmaco sperimentale diverso dal rivaroxaban o con un dispositivo medico entro 30 giorni prima del trattamento
    Soltanto per il Gruppo C:
    12.Storia clinica positiva per patologia gastrointestinale o intervento chirurgico con assorbimento compromesso
    E.5 End points
    E.5.1Primary end point(s)
    The primary variables for pharmacokinetics will be the standard
    pharmacokinetic (PK) parameters for exposure, area under the curve
    (AUC) and Cmax, derived via population PK approaches.
    Le variabili primarie di farmacocinetica saranno costituite dai parametri farmacocinetici (PK) standard relativi a esposizione, area sotto la curva (AUC) e Cmax, ricavati mediante approcci PK di popolazione
    E.5.1.1Timepoint(s) of evaluation of this end point
    For Group A and B
    Depending on age, PK samples are collected at several time points within
    24 hours after drug administration
    For Group C
    PK samples are collected at several time points within 28 hours after
    drug administration
    Per i gruppi A e B
    A seconda dell'età, i campioni di PK vengono raccolti in diversi momenti all'interno delle
    24 ore dopo la somministrazione del farmaco in studio
    Per il gruppo C
    I campioni di PK vengono raccolti in diversi momenti entro le 28 ore dopo la
    somministrazione del farmaco in studio
    E.5.2Secondary end point(s)
    The principal safety outcome is the composite of major bleeding and
    clinically relevant non-major bleeding.
    Il principale risultato sul piano della sicurezza sar¿ dato dalla somma degli episodi di sanguinamento maggiore e di quelli non maggiori ma
    clinicamente rilevanti.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 24 hrs after drug administration with additional followup on day 8
    (+3) days.
    A 24 ore dopo la somministrazione del farmaco con ulteriore follow-up al giorno 8 (+ 3 giorni)
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetics
    Farmacocinetica
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Australia
    Canada
    United States
    Austria
    Belgium
    Finland
    France
    Hungary
    Ireland
    Italy
    Spain
    Sweden
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days27
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 22
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 36
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children age 2 months to 12 years
    Bambini da 2 mesi a 12 anni di et¿
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 58
    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)
    As dictated by the physician
    A discrezione dello Sperimentatore
    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 Decision2015-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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