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    Summary
    EudraCT Number:2014-002807-10
    Sponsor's Protocol Code Number:MK5592-097
    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:2015-06-15
    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 number2014-002807-10
    A.3Full title of the trial
    A Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) and Powder for Oral Suspension Formulations of Posaconazole (POS) in Immunocompromised Pediatric Subjects with Neutropenia
    Estudio de la seguridad, tolerabilidad y farmacocinética de dos formulaciones de posaconazol (POS), por vía intravenosa (IV) y en polvo para suspensión oral, en pacientes pediátricos inmunodeprimidos con neutropenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pediatric PK Study (POS IV and PFS)
    Estudio Pediatrico PK (POS IV y PFS)
    A.3.2Name or abbreviated title of the trial where available
    Pediatric PK Study (POS IV and PFS)
    Estudio Pediatrico PK (POS IV y PFS)
    A.4.1Sponsor's protocol code numberMK5592-097
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/289/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34629 08 04 66
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 Noxafil 300 mg concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameposaconazole
    D.3.2Product code MK-5592
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPosaconazole
    D.3.9.1CAS number 171228-49-2
    D.3.9.2Current sponsor codeMK-5592
    D.3.9.3Other descriptive namePosaconazole
    D.3.9.4EV Substance CodeSUB20322
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 nameposaconazole
    D.3.2Product code MK-5592
    D.3.4Pharmaceutical form Powder and solvent for oral solution
    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 INNMK-5592
    D.3.9.1CAS number 171228-49-2
    D.3.9.2Current sponsor codeMK-5592
    D.3.9.3Other descriptive nameposaconazole
    D.3.9.4EV Substance CodeSUB20322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    Prophylaxis of invasive fungal infections in immunocompromised pediatric subjects with neutropenia or expected neutropenia.
    Profilaxis de infecciones antifúngicas invasivas en pacientes pediátricos inmunodeprimidos con neutropenia o neutropenia esperada
    E.1.1.1Medical condition in easily understood language
    Pediatric pts at risk of fungal infection due to a poor immune system after chemotherapy or on drugs lowering the body´s ability to fight infection who have/are expected to have low white blood cells.
    Pacientes pediátricos con riesgo de infección fúngica por bajo sistema inmune debido a quimioterapia o fármacos que debilitan el cuerpo para combatir infecciones y tiene o pueden tener neutropenia
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the pharmacokinetics (PK) of POS IV solution and POS Powder for Oral Suspension (PFS) administered to immunocompromised pediatric subjects (ages 2 years to 17 years)with neutropenia or expected neutropenia.
    Evaluar la farmacocinética (FC) de dos formulaciones de POS, en solución IV y en PPS, en pacientes pediátricos (de 2 a 17 años de edad) inmunodeprimidos con neutropenia actual o previsible
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of POS IV solution and POS Powder for Oral Suspension (PFS) administered to immunocompromised pediatric subjects (ages 2 years to 17 years) with neutropenia or expected neutropenia.
    Evaluar la seguridad y la tolerabilidad de dos formulaciones de POS, en solución IV y en PPS, en pacientes pediátricos (de 2 a 17 años de edad) inmunodeprimidos con neutropenia actual o previsible
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (buccal swab) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    Merck llevará a cabo investigaciones biomédicas futuras con las muestras obtenidas específicamente con estos fines durante este ensayo clínico.Estas investigaciones tendrán por objeto el análisis de biomarcadores para abordar aspectos nuevos que no se describen en otras partes del protocolo (como parte del ensayo principal) y solo se llevarán a cabo en muestras de los sujetos que hayan otorgado el consentimiento correspondiente. El objetivo de la obtención de muestras para investigaciones biomédicas futuras consiste en estudiar e
    identificar biomarcadores que proporcionen información a los científicos
    sobre las enfermedades y sus tratamientos. El objetivo último es utilizar
    tal información para desarrollar vacunas y fármacos más seguros y
    eficaces o para garantizar que los pacientes reciban la dosis correcta del
    fármaco o la vacuna adecuados en el momento preciso.
    E.3Principal inclusion criteria
    1)Be a child or adolescent of either sex and of any race, 2 to 17 years of age at the time of screening.
    2)Have a parent/guardian or legally authorized representative who is willing to give written informed consent. Assent will be obtained from minors according to institutional practices. The guardian/subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
    3)Have documented or anticipated neutropenia (ANC < 500/mm3 [0.5 x 109 /L]) expected to last for at least 7 days following start of study treatment in at least one of the following clinical situations:
    a.Acute leukemia,
    b.Myelodysplasia,
    c.Severe aplastic anemia,
    d.Recipients of Autologous HSCT,
    e.High risk neuroblastoma,
    f.Advanced stage non-Hodgkin´s lymphoma (NHL),
    g.Recipients of allogeneic HSCT during the pre-engraftment (neutropenic) period
    h.Hemophagocytic lymphohistiocytosis
    4)Must have a central line (e.g. central venous catheter, peripherally inserted central catheter, etc.) in place or planned to be in place prior to beginning IV study therapy.
    5)If the subject is of reproductive potential and is not surgically sterile (or their partner is not surgically sterile), must agree to remain abstinent* or use (or have their partner use) a medically accepted method of birth control starting from the time of consent through 1 month after the completion of the study. Acceptable methods of birth control? are: intrauterine device (IUD) with spermicide, diaphragm or cervical cap (if acceptable to local standard of care) with spermicide, contraceptive sponge with spermicide, condom with spermicide, and any registered and marketed hormonal contraceptive that contains an estrogen and/or progestational agent, including oral,
    subcutaneous, intrauterine or intramuscular agents that is used with a barrier method.
    Sexually active females of childbearing potential must have a negative urine
    pregnancy test which must be followed up with a confirmed negative serum
    pregnancy test (?-HCG) within 48 hours following the screening visit.
    * Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject´s preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ERCs/IRBs.
    Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation
    methods, etc.) and withdrawal are not acceptable methods of contraception.
    ?If a contraceptive method listed above is restricted by local regulations/guidelines, then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country/region.
    1)Ser un niño o adolescente de cualquier sexo y raza y tener entre 2 y 17 años de edad en el momento de la selección.
    2)Tener un padre, tutor o representante legal dispuesto a otorgar su consentimiento informado por escrito. El asentimiento de los menores se obtendrá conforme a las prácticas del centro. El tutor y el paciente también podrán otorgar su consentimiento y asentimiento para las investigaciones biomédicas futuras. No obstante, se podrá participar en el ensayo principal sin necesidad de participar en las investigaciones biomédicas futuras.
    3)Presentar neutropenia confirmada o previsible (recuento absoluto de neutrófilos [RAN] < 500/mm3 [0,5 x 109/l]) que se prevé que dure al menos 7 días desde el comienzo del tratamiento del estudio en al menos una de las situaciones clínicas siguientes:
    a.Leucemia aguda
    b.Mielodisplasia
    c.Anemia aplásica grave
    d.Receptores de auto-TCPH
    e.Neuroblastoma de alto riesgo
    f.Linfoma no hodgkiniano (LNH) en estadio avanzado
    g.Receptores de alo-TCPG, antes del prendimiento (neutropenia)
    h.Linfohistiocitosis hemofagocítica
    4)Tener implantada una vía central (por ejemplo, catéter venoso central, catéter central de acceso periférico, etc.) o estar previsto implantarla antes de empezar el tratamiento IV del estudio.
    5)Si el paciente está en edad fértil y no se ha sometido a esterilización quirúrgica (o su pareja no se ha sometido a esterilización quirúrgica), debe comprometerse a practicar la abstinencia* o utilizar (el paciente o su pareja) un método anticonceptivo médicamente aceptado desde el momento del consentimiento informado hasta un mes después de la finalización del estudio. Son métodos anticonceptivos aceptables? los siguientes: dispositivo intrauterino (DIU) con espermicida, diafragma o capuchón cervical (si es aceptable según las normas asistenciales locales) con espermicida, esponja anticonceptiva con espermicida y cualquier anticonceptivo hormonal registrado y comercializado que contenga un estrógeno o un progestágeno (o ambos), administrado por vía oral, subcutánea, intrauterina o intramuscular y utilizado junto con un método de barrera. Las niñas en edad fértil que sean sexualmente activas deberán tener un resultado negativo en la prueba de embarazo en orina que deberá confirmarse con un resultado negativo en la prueba de embarazo en suero (?-HCG) en las 48 horas siguientes a la visita de selección.
    *Se permite la abstinencia (de actividad heterosexual) como único método anticonceptivo si se utiliza sistemáticamente, formando parte del modo de vida preferido y habitual de la paciente y si se considera aceptable por las autoridades sanitarias locales. La abstinencia periódica (p. ej., métodos de calendario, ovulación, sintotérmicos, postovulación, etc.) y el coito interrumpido no se consideran métodos anticonceptivos aceptables.
    ?Si alguno de los métodos anticonceptivos de la lista anterior está prohibido por las normas o reglamentos locales, no se considera un método aceptable para los participantes en los centros de este país o región.
    E.4Principal exclusion criteria
    The subject must be excluded from participating in the trial if the subject:

    1)Has a proven or probable IFI, as defined by the 2008 European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) consensus group criteria, at the time of screening.
    2)Has received POS (any formulation) within the past 10 days prior to screening.
    3)Is receiving prohibited drugs (has not met the required washout periods as listed in Section 5.5.1) at the time of randomization or is expected to receive such prohibited medications during the course of study therapy.
    4)Has laboratory results that are outside of normal limits at screening, as follows:
    a)Moderate or severe liver dysfunction, as defined as:
    -Aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN), OR
    -Alanine aminotransferase (ALT) > 5 times the ULN, OR
    -Serum total bilirubin >2.5 times the ULN, OR
    -AST or ALT > 3 times ULN with total bilirubin > 2 times ULN,
    b)Calculated creatinine clearance <30 mL/min. Creatinine clearance will be calculated using the following equation:
    Creatinine clearance = k X height (cm)
    Serum creatinine (mg/dL)
    Where k = 0.55 for male and female children 1-13 years old; k = 0.7 for adolescent males 13-18 years old, k= 0.55 for adolescent females 13-18 years old; (Schwartz equation)
    5)Has QTc prolongation (either based on Fridericia or Bazett´s correction) at screening defined as :
    a)Symptomatic QTc prolongation >450 msec (males) or >470 msec (females)
    OR
    b)Any QTc prolongation of >500 msec
    6)Is pregnant or intends to become pregnant during the course of the study, or is breastfeeding at screening.
    7)Has a history of anaphylaxis attributed to the azole class of antifungal agents.
    8)Has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study, evaluations or optimal participation in the study including:
    a)Not expected to receive a minimum of 10 days of POS IV solution
    9)Has previously participated in this study
    10)Has participated in any Phase 1 clinical study for a medication classified as an Investigational New Drug (IND) within 30 days prior to enrollment or is expected to participate in such a study within 60 days following randomization. Participation in non-IND studies is permitted.
    11) Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
    Se excluirá de participar en el ensayo a los pacientes que cumplan alguno de estos criterios:
    1)Tener, en el momento de la selección, una MI confirmada o probable según los criterios de consenso de 2008 de la Organización Europea para la Investigación y el Tratamiento del Cáncer y el Grupo para el Estudio de las Micosis (EORTC/MSG).
    2)Haber recibido POS (en cualquier formulación) en los 10 días precedentes a la selección.
    3)Estar recibiendo medicamentos prohibidos (o no cumplir los períodos de depuración que se indican en la sección 5.5.1) en el momento de la aleatorización, o estar previsto que los reciba a lo largo del tratamiento del estudio.
    4)Tener, en el momento de la selección, resultados analíticos fuera de los límites de la normalidad como los siguientes:
    a)Disfunción hepática moderada o grave, definida como:
    -Aspartato-aminotransferasa (AST) > 5 veces el límite superior de la normalidad (LSN), O BIEN
    -Alanina-aminotransferasa (AST) > 5 veces el LSN, O BIEN
    -Bilirrubina sérica total > 2,5 veces el LSN, O BIEN
    -AST o ALT > 3 veces por encima del LSN con bilirrubina total > 2 veces por encima del LSN
    b)Aclaramiento de creatinina calculado < 30 ml/min. El aclaramiento de creatinina se calculará mediante la ecuación siguiente:
    Aclaramiento de creatinina = k X estatura (cm)
    creatinina sérica (mg/dl)
    Donde k = 0,55 para los niños y niñas de 1 a 13 años; k = 0,7 para los adolescentes varones de 13 a 18 años; y k = 0,55 para las adolescentes de 13 a 18 años (ecuación de Schwartz)
    5)Presentar, en el momento de la selección, una prolongación del intervalo QTc (según la corrección de Fridericia o de Bazett) definida como:
    a)Prolongación sintomática del intervalo QTc por encima de 450 ms en niños y de 470 ms en niñas.
    O BIEN
    b)Cualquier prolongación del intervalo QTc por encima de 500 ms
    6)Estar embarazada o tener intención de quedarse embarazada durante el estudio, o estar en período de lactancia en el momento de la selección.
    7)Tener antecedentes de anafilaxia atribuida al grupo de los antimicóticos azólicos.
    8)Presentar alguna enfermedad o situación de importancia clínica, distinta de la enfermedad en estudio que, en opinión del investigador, pueda interferir en las evaluaciones del ensayo o en la participación óptima en el estudio, como por ejemplo:
    a)Es previsible que el paciente no vaya a recibir POS en solución IV durante un mínimo de 10 días.
    9)Haber participado con anterioridad en este estudio.
    10)Haber participado en algún estudio clínico de fase I con un medicamento clasificado como producto en investigación (PEI) en los 30 días previos a la inclusión, o estar previsto que participe en un estudio de ese tipo en los 60 días siguientes a la aleatorización. Se permite la participación en estudios sin PEI.
    11)Ser o tener un familiar directo (por ejemplo, cónyuge, padre/madre o tutor legal, hermano o hijo) que forme parte del personal del centro del estudio o del promotor implicado directamente en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be steady-state Cavg for both POS IV solution and POS PFS. Cavg will be calculated for patients in each age group per dose cohort.
    El criterio de valoración principal será la Cpro observada con POS en solución IV y con POS en PPS. La Cpro se calculará en los pacientes de cada grupo de edad por cohorte de dosis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cavg will be measured at steady state, occurring at approximately Day 7-10 for each formulation.
    Cpro será medida en estado de equilibrio en aproximadamente los días 7-10 para cada formulación.
    E.5.2Secondary end point(s)
    Safety & tolerability of POS IV solution and POS PFS, as measured by adverse events, physical examinations, vital signs, clinical laboratory test results, and electrocardiogram (ECG) results.
    La evaluación de la seguridad y tolerabilidad de POS IV y POS polvo para suspensión oral se basará en los acontecimientos adversos, la exploración física, las constantes vitales, los resultados de los análisis clínicos y los resultados del electrocardiograma (ECG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    All subjects who receive at least one dose of study drug will be included in the safety analysis (14 days following the end of study therapy).
    Todos los sujetos que reciben al menos una dosis del fármaco del estudio se incluirán en el análisis de seguridad (14 días siguientes al final del tratamiento del estudio).
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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
    Pediatric PK 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 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.8.2.4Number of treatment arms in the trial1
    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 EEA16
    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
    Belgium
    Czech Republic
    Denmark
    Germany
    Guatemala
    Italy
    Norway
    Peru
    Spain
    Sweden
    Thailand
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months23
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months23
    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: 60
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The subjects are incapable of giving consent personally because they are under-aged.
    Los sujetos son incapaces de dar su consentimiento personalmente porque son menores de edad.
    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 49
    F.4.2.2In the whole clinical trial 83
    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)
    Investigator standard of care.
    Practica Clinica Habitual
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-03
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