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    Summary
    EudraCT Number:2015-005732-18
    Sponsor's Protocol Code Number:DU176b-A-U157
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-07-15
    Trial 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 number2015-005732-18
    A.3Full title of the trial
    A Phase 1, Open-Label, Single-dose, Non-randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients
    Studio di fase 1, in aperto, a dose singola, non randomizzato atto a valutare la farmacocinetica (Pharmacokinetics, PK) e la farmacodinamica (Pharmacodynamics, PD) di edoxaban in soggetti pediatrici
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of an oral anticoagulant (Edoxaban) in children
    Studio di un anticoagulante orale (Edoxaban) nei bambini
    A.4.1Sponsor's protocol code numberDU176b-A-U157
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02303431
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/302/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDaiichi Sankyo , Inc.
    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 supportDaiichi Sankyo Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReal Regulatory Limited
    B.5.2Functional name of contact pointClinical Trial Information Contact
    B.5.3 Address:
    B.5.3.1Street AddressHudson House, 8 Tavistock Street, Covent Garden
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2E 7PP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044(0)2031787140
    B.5.6E-maileucta@dsi.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 Yes
    D.2.1.1.1Trade name Lixiana (60 mg Film-coated tablet)
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Europe GmbH
    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.3.1Product nameEdoxaban tosylate
    D.3.2Product code DU-176b
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNEdoxaban
    D.3.9.1CAS number 480449-70-5
    D.3.9.2Current sponsor codeEdoxaban
    D.3.9.4EV Substance CodeSUB32701
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    D.2.1.1.1Trade name Lixiana
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Europe GmbH
    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.3.1Product nameEdoxaban tosylate
    D.3.2Product code DU-176b
    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 INNEdoxaban
    D.3.9.1CAS number 480449-70-5
    D.3.9.2Current sponsor codeEdoxaban
    D.3.9.4EV Substance CodeSUB32701
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 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 Yes
    D.2.1.1.1Trade name Lixiana (30 mg film-coated tablet)
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Europe GmbH
    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.3.1Product nameEdoxaban tosylate
    D.3.2Product code DU-176b
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNEdoxaban
    D.3.9.1CAS number 480449-70-5
    D.3.9.2Current sponsor codeEdoxaban
    D.3.9.4EV Substance CodeSUB32701
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Edoxaban is being investigated for use in pediatric patients who may require anticoagulation therapy.
    Edoxaban verrà sperimentato per
    l’uso nella popolazione pediatrica che necessita di terapie anticoagulanti
    E.1.1.1Medical condition in easily understood language
    A study of Edoxaban in children.
    studio di Edoxaban nei bambini
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10010495
    E.1.2Term Congenital heart disease NOS
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10057396
    E.1.2Term Thrombophilia
    E.1.2System Organ Class 100000004851
    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 PK of Edoxaban in pediatric patients following oral single-dose administration.
    Caratterizzare la PK di edoxaban in pazienti pediatrici in seguito alla somministrazione orale di una dose singola
    E.2.2Secondary objectives of the trial
    - To evaluate the PD effects of edoxaban in pediatric patients following single-dose oral administration
    - To evaluate the safety and tolerability of single-dose oral administration of edoxaban in pediatric patients
    - To assess metabolite exposure (D21-2393, D21-3231, D21-1402, and D21-2135) in pediatric patients
    - To evaluate the palatability (bitterness, sweetness, and overall taste or aroma) of the liquid oral suspension of edoxaban
    - Valutare gli effetti di PD di edoxaban in pazienti pediatrici in seguito alla somministrazione orale di una dose singola
    - Valutare la sicurezza e la tollerabilità della somministrazione orale di
    una dose singola di edoxaban in pazienti pediatrici
    - Valutare l’esposizione al metabolita (D21-2393, D21-3231, D21-1402 e D21-2135) nei pazienti pediatrici
    - Valutare la palatabilità (sapore amaro, dolce e il gusto o l’aroma
    complessivamente) della sospensione orale liquida di edoxaban
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to provide written informed assents (patients, when applicable) and ICFs (signed by parent/legal guardian) prior to participating in the study
    2. Male or female patients 0 to < 18 years of age on the day of dosing
    3. Patients 2 to < 18 years of age must have a body mass index (BMI) between the 5th and 95th percentile based on the 2000 CDC Growth Charts7 (the maximum number of patients in each dose group that have a BMI between 85th and 95th percentile should not be more than 2 patients). Patients < 2 years of age must have a body weight between the 5th and 90th percentile based on the 2000 CDC Growth Charts7
    4. Female patients who have had menarche must test negative for pregnancy at screening and check-in
    5. Female patients who have had menarche and are sexually active must use an acceptable contraception method for at least 30 days prior to edoxaban dose
    6. Patients/Legal guardian(s) must agree to food and drug restrictions during the study
    7. Patients must agree to abstain from the use of nonsteroidal anti-inflammatory drugs (such as ibuprofen), and antiplatelet and anticoagulant agents (except for low-dose aspirin) from 24 hours prior to edoxaban dose until after the last PK sample is collected
    8. Patients on low-dose aspirin treatment (1 to 5 mg/kg/day, maximum of 100 mg/day) with an interruption of aspirin 24 hours prior to edoxaban dose and resuming 24 hours after edoxaban dose are permitted to participate in the study per the Investigator’s judgment that this does not place the patients at risk
    9. Patients must agree to abstain from CYP3A4 inhibitors/inducers and P-gp inhibitors/inducers for 14 days prior to the edoxaban dose to until after the last PK sample is collected (See Section 5.2)
    10. Patients must agree to abstain from and/or legal guardians must agree not to give the patient cola, tea, coffee, chocolate, and other caffeinated drinks and food from 48 hours before dose administration through check-out (See Section 5.3 for a complete list)
    11. Other than signs and symptoms characteristic to their disease state, patients are to be in good health as determined by the absence of clinically significant deviations from normal, with respect to medical and surgical history, physical examination, vital signs, and laboratory reports, as deemed by the Investigator and the Sponsor, prior to enrollment
    12. Patients must agree to abstain from and/or legal guardians must agree not to give the patient St. John’s Wort and food/supplement and beverages containing grapefruit, grapefruit juice, and Seville oranges from 14 days before the first dose through the end of the study (See Section 5.3)
    - Pazienti che abbiano fornito il proprio consenso informato (quando applicabile) o i cui genitori/tutori legali abbiano dato il loro consenso

    - Pazienti da 0 a < 18 anni di età di entrambi i sessi, che possono necessitare di terapia anticoagulante.

    - Pazienti femmina che non siano incinte e che abbiano acconsentito all’uso di metodi contraccettivi per evitare una gravidanza durante il trattamento
    E.4Principal exclusion criteria
    1. History (within the last 6 months) of abnormal coagulation tests during screening, as defined by local laboratory reference ranges, which are not explained by anticoagulation therapy
    2. Stroke where anticoagulant therapy is contraindicated
    3. Patients with stage 2 hypertension defined as blood pressure confirmed > 99th percentile + 5 mmHg
    4. Patients with renal function less than 50% of normal for age and size as determined by the National Kidney Disease Education Program version of the Schwartz formula8
    5. Actively bleeding or has a high risk of bleeding
    6. Has a currently active gastrointestinal ulceration or a known history of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding including bleeding from hemorrhoids) within the previous 6 months
    7. Has known diabetic retinopathy
    8. Has thrombocytopenia at screening (< 20 × 109/L)
    9. Has had other unrelated clinically significant illness within 4 weeks prior to Day 1, predose
    10. Planned invasive procedures during or within 24 hours of study drug administration
    11. Patient is receiving high-dose aspirin concurrently or within 2 weeks prior to dosing
    12. Use of P-gp or CYP 3A4 inhibitors or inducers within 14 days prior to the edoxaban dose and expected to continue through the study duration
    13. Patients with history of major bleeding and/or neurosurgery within 6 months of dosing
    14. Patients with history of major trauma or surgery within the last month
    15. Patients with known malabsorption disorders (e.g., cystic fibrosis or short bowel syndrome)
    16. Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk or alanine transaminase (ALT) > 5 times the upper limit of normal (ULN) or total bilirubin > 2 times the ULN with direct bilirubin > 20% of the total
    17. Patient is currently enrolled in another investigational device or drug study, or is receiving other investigational agents. Patients must have completed the prior clinical study at least 30 days prior to dosing
    18. Patients of childbearing potential (post-menarche) who are sexually active and are not using approved contraception; who are pregnant (as based on test results); or are breastfeeding
    19. Females with history of abnormal menses, including history of menorrhagia (heavy menstrual bleeding), metrorrhagia, or polymenorrhea
    20. Patient has known sensitivity to the investigational product (IP) or any of its excipients
    21. Positive drug or alcohol screen (excluding cotinine) at screening for patients 12 years of age or older, for newborns and for patients who are being breastfed
    22. Patients who have received a transfusion or any blood products within 30 days prior to the first dose
    23. Any major bleeding during prior anticoagulant therapy
    24. Patients with any condition, that as judged by the Investigator, would place the patient at increased risk of harm if he/she participated in the study
    - Pazienti che mostrino test della coagulazione anormali durante lo screening, non spiegabili con la terapia anticoagulante
    - Pazienti soggetti a ictus dove la terapia anticoagulante è controindicata
    - Pazienti con stadio 2 di ipertensione definita come pressione sanguigna confermata > 99th percentile + 5 mmHg
    - Pazienti con funzionalità renale inferiore al 50% della norma per età e peso secondo quanto determinato dal National Kidney Disease Education Program versione della formula di Schwartz
    - Pazienti con sanguinamenti in atto o ad alto rischio di sanguinamento
    - Pazienti con un’ulcera gastrointestinale attiva o con una storia nota di ulcera peptica o sanguinamento gastrointestinale (compresi ematemesi, melena, o sanguinamento rettale compreso sanguinamento da emorroidi) nei 6 mesi precedenti
    - Pazienti con storia clinica di retinopatia diabetica
    - Pazienti con trombocitopenia allo screening (< 20 × 109/L)
    - Pazienti che stanno assumendo o hanno assunto alte dosi di aspirina in concomitanza o entro 2 settimane prima del dosaggio
    - Pazienti che fanno uso di inibitori o induttori della P-gp e del CYP3A4 entro 14 giorni prima della dose di edoxaban e dovrebbero proseguire la terapia per tutta la durata studio
    - Pazienti con malattia epatica associata a coagulopatia che comporta un rischio emorragico clinicamente significativo o alanina transaminasi (ALT)> 5 volte il limite superiore del valore normale (ULN) o bilirubina totale> 2 volte il limite superiore normale con bilirubina diretta> 20% del totale
    E.5 End points
    E.5.1Primary end point(s)
    - The PK endpoints will include PK parameters such as apparent systemic clearance (CL/F) and apparent volume of distribution (V/F). If data permit, derived PK parameters such as AUC and metabolite/parent ratios for AUCs will also be estimated.
    Parametri di farmacocinetica, come
    la clearance sistemica (CL/F) apparente, il volume di distribuzione (V/F) apparente e
    l’area sotto la curva concentrazione-tempo (AUC) per edoxaban e metaboliti e rapporti
    metabolita/farmaco progenitore per AUC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PK:
    - 0.25 to 1 hour postdose (1 sample)
    - 1.5 to 3 hours postdose (1 sample)
    - 3.5 to 6 hours postdose (1 sample)
    - 6.5 to 8 hours postdose (1 sample)
    - 8.5 to 14 hours postdose (1 sample)
    - 24 to 36 hours postdose (1 sample)
    - 48 to 54 hours postdose (1 sample)
    For subsequent age cohorts, emerging PK concentration-time data from completing patients will be analyzed on an ongoing basis and used to refine and optimize the PK blood sampling scheme (i.e., both the number of samples and the sampling windows).
    Endpoint relativo alla PK:
    - da 0,25 a 1 ora post- dose (1 campione)
    - da 1,5 a 3 ore post- dose (1 campione)
    - da 3,5 a 6 ore post- dose (1 campione)
    - da 6,5 a 8 ore post- dose (1 campione)
    - da 8,5 a 14 ore post- dose (1 campione)
    - da 24 a 36 ore post- dose (1 campione)
    - da 48 a 54 ore post-dose (1 campione)
    For le coorti di età successive, dati sulla concentrazione-tempo saranno analizzati su base continuativa e utilizzati per perfezionare e ottimizzare lo
    schema di campionamento del sangue PK
    E.5.2Secondary end point(s)
    - The PD endpoints will include observed, change-from-baseline, and percent-change-from-baseline PT, aPTT, and anti-FXa.
    - Safety assessments will include: AEs, physical examination findings, vital signs, standard hematology, clinical chemistry, coagulation, and urinalysis laboratory tests. Note, urinalysis will be performed with plastic bags with a sticky strip from neonates and infants with diapers.
    - Palatability of the liquid formulation will be assessed using visual analog scale (VAS) scores.
    Endpoint relativo alla Farmacodinamica includerà i valori di PT, aPTT e anti-
    FXa osservati, la loro variazione dal basale e la variazione percentuale dal
    basale.
    Endpoint relativo alla Sicurezza include la valutazione di eventi avversi, esiti
    dell’esame obiettivo, segni vitali, valutazioni cliniche di laboratorio e
    coagulazione e analisi delle urine.
    Endpoint altri: palatabilità della formulazione liquida sarà valutata usando i
    punteggi della scala analogica visiva (Visual Analog Scale, VAS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Coagulation:
    - Predose (1 sample)
    - 0.25 to 1 hour postdose (1 sample)
    - 1.5 to 3 hours postdose (1 sample)
    - 3.5 to 6 hours postdose (1 sample)
    - 6.5 to 8 hours postdose (1 sample)
    - 24 to 36 hours postdose (1 sample)
    All other secondary endpoints - throughout the study
    Coagulazione:
    - Pre-dose (1 campione)
    - Da 0.25 a 1 ora post dose (1 campione)
    - da 1.5 a 3 ore post dose (1 campione)
    - da 3.5 a 6 ore post dose (1 campione)
    - da 6.5 a 8 ore post dose (1 campione)
    - da 24 a 36 ore post dose (1 campione)
    tutti gli altri endpoints saranno valutati nel corso dello studio
    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 Yes
    E.6.13.1Other scope of the trial description
    Metabolite exposure, palatability
    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
    PK, PD safety study
    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 Yes
    E.8.1.7.1Other trial design description
    Single-dose
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Canada
    France
    Italy
    Jordan
    Spain
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 48
    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: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    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 <7 will be enrolled solely via parental consent. Children 7 - 17 will be enrolled via assent and parental consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 48
    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)
    Patients will continue normal treatment.
    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 Decision2016-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-04
    P. End of Trial
    P.End of Trial StatusOngoing
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