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    Summary
    EudraCT Number:2015-003002-17
    Sponsor's Protocol Code Number:63623872FLZ2002
    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:2015-10-15
    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 number2015-003002-17
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection
    Estudio Fase 2, aleatorizado, doble ciego, controlado con placebo para evaluar la farmacocinética, seguridad y actividad antiviral del JNJ-63623872 en combinación con oseltamivir en pacientes adolescentes, adultos y ancianos hospitalizados por infección de gripe A.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection
    Estudio para evaluar la farmacocinética, seguridad y actividad antiviral del JNJ-63623872 en combinación con oseltamivir en pacientes adolescentes, adultos y ancianos hospitalizados por infección de gripe A.
    A.3.2Name or abbreviated title of the trial where available
    OPAL
    OPAL
    A.4.1Sponsor's protocol code number63623872FLZ2002
    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 R&D, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 91 7228100
    B.5.5Fax number+34 91 7228628
    B.5.6E-mailagonza45@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-63623872
    D.3.2Product code JNJ-63623872
    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 INNJNJ-63623872-ZCD
    D.3.9.3Other descriptive nameJNJ-63623872-ZCD
    D.3.9.4EV Substance CodeSUB174944
    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.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 Tamiflu
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameTamiflu
    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.3.8INN - Proposed INNOseltamivir
    D.3.9.1CAS number 204255-11-8
    D.3.9.3Other descriptive nameOSELTAMIVIR PHOSPHATE
    D.3.9.4EV Substance CodeSUB12544MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Tamiflu
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameTamiflu
    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.3.8INN - Proposed INNOseltamivir
    D.3.9.1CAS number 204255-11-8
    D.3.9.3Other descriptive nameOSELTAMIVIR PHOSPHATE
    D.3.9.4EV Substance CodeSUB12544MIG
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Influenza A virus infection
    Infección por virus de gripe A
    E.1.1.1Medical condition in easily understood language
    Influenza A virus infection
    Infección por virus de gripe A
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10022002
    E.1.2Term Influenza A virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the pharmacokinetic (PK) parameters of JNJ-63623872 in combination with oseltamivir in adolescents (aged 13 to ?17 years) and elderly subjects (aged 65 to ?85 years) compared to adults (aged 18 to ?64 years) with influenza A infection.
    El objetivo principal es evaluar los parámetros farmacocinéticos (FC) de JNJ-63623872 en combinación con oseltamivir en adolescentes (de 13 a 17 años) y pacientes ancianos (de 65 a 85 años) en comparación con adultos (de 18 a 64 años) con infección por gripe A.
    E.2.2Secondary objectives of the trial
    Secondary objectives include the assessment of the following parameters in the JNJ-63623872 treatment arm compared to the control arm:
    1. Safety and tolerability.
    2. The time to influenza viral negativity based on quantitative reverse transcription polymerase chain reaction (qRT-PCR) and/or viral culture from nasal mid-turbinate (MT) swabs and, if applicable, based on PCR-based rapid molecular testing from nasal MT swabs.
    3. Viral load over time and rate of decline in viral load during treatment as measured by qRT-PCR and/or by viral culture.
    4. Area under the curve (AUC) of viral load as measured by qRT-PCR and/or by viral culture.
    5. Disease status and incidence of complications associated with influenza after the start of study treatment, and disease progression.
    6. Change in duration and severity of clinical symptoms as measured by the Flu-PRO.

    Additional secondary objectives and exploratory objectives can be found in the protocol: Section 2, pages 29-30
    Los objetivos secundarios son la evaluación de los parámetros siguientes en los grupos de tratamiento con JNJ-63623872 en comparación con el grupo de control:
    Seguridad y tolerabilidad.
    Tiempo transcurrido hasta la negatividad vírica de la gripe basada en la reacción en cadena de la polimerasa con transcripción inversa cuantitativa(qRT-PCR)y/o en el cultivo vírico de frotis del cornete nasal medio, y basado en el análisis molecular mediante PCR de los frotis del cornete nasal.
    Carga vírica a lo largo del tiempo y tasa de disminución de la misma durante el tratamiento determinada por qRT-PCR y/o cultivo vírico.
    Área bajo la curva de la carga vírica, medida mediante qRT-PCR y/o cultivo vírico.
    Estado de la enfermedad, incidencia de complicaciones asociadas con la gripe después del inicio del tratamiento y progresión de la enfermedad.
    Modificación de la duración e intensidad de los síntomas determinada por Flu-PRO.
    Ver otros objetivos en la Sección2, pág29-30 del Protocolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants requires hospitalization to treat influenza infection and/or to treat complications of influenza infection
    - Participants tested positive for influenza A infection within 1 day of signing of the informed consent form (ICF)/assent form using a polymerase chain reaction (PCR)-based rapid molecular diagnostic assay
    - Participants must be capable of swallowing study medication tablets and capsules
    - Each participant (or their legally acceptable representative) must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
    - Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
    - Los pacientes tienen que estar ingresados para tratar la infección de la gripe y/o para tratar las complicaciones debidas a la infección de la gripe.
    - Los pacientes dieron positivo en infección por gripe A en el plazo de un día antes o después de firmar el documento de consentimiento informado (DCI)/asentimiento determinado mediante una prueba diagnóstica molecular rápida con PCR.
    - Los pacientes deben poder tragar los comprimidos y las cápsulas de la medicación del estudio.
    - Todos los pacientes (o sus representantes legales) deben firmar el HCI indicando que entienden el objetivo y los procedimientos requeridos en el estudio y su voluntad de participar en el mismo.
    - Los pacientes deben estar dispuestos y ser capaces de respetar las prohibiciones y restricciones especificadas en el protocolo.
    E.4Principal exclusion criteria
    - Participants received more than 3 doses of the influenza antiviral medication oseltamivir, zanamivir, or peramivir since
    the start of the influenza symptoms, or ribavirin within 6 months prior to Screening
    - Participant is unwilling to undergo regular nasal Mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal specimens
    - Participants is immunocompromised, whether due to underlying medical condition (example, malignancy) or medical therapy (example, medications, chemotherapy, radiation, post-transplant)
    - Participant is undergoing peritoneal dialysis, hemodialysis, or hemofiltration
    - Participant has an estimated glomerular filtration rate (eGFR) less than or equal to (<=)30 milliliter (mL)/minute (min)/1.73 meter^2 (m^2) according to the Modification of Diet in Renal Disease (MDRD) equation, assessed at Screening or based on the most recent clinically relevant creatinine value if available
    - Partcipant has a known diagnosis acute viral hepatitis
    - Los pacientes recibieron más de tres dosis de medicación antivírica para la gripe, oseltamivir, zanamivir o peramivir desde la aparición de los síntomas de la gripe o ribavirina en el plazo de los seis meses anteriores a la selección.
    - Los pacientes no desean someterse a frecuentes frotis del cornete nasal medio o tiene una alteración física que limita la capacidad de extraer muestras nasales frecuentes.
    - Los pacientes están inmunodeprimido, debido a una enfermedad subyacente (por ej., neoplasia maligna) o tratamiento médico (por ej., medicamentos, quimioterapia, radiación o después de un trasplante).
    - Los pacientes se someten a diálisis peritoneal, hemodiálisis o hemofiltración.
    - Los pacientes presentan una tasa de filtración glomerular (eGFR) inferior o igual a 30ml/min/1,73m² de conformidad con la ecuación utilizada en el estudio de modificación de la dieta en la enfermedad renal (Modification of Diet in Renal Disease, MDRD), evaluada en la selección o basada en el valor de creatinina clínicamente pertinente más reciente, si existe.
    - Los pacientes tienen un diagnostico conocido de hepatitis viral aguda
    E.5 End points
    E.5.1Primary end point(s)
    1- Trough Plasma Concentration (Ctrough) of JNJ-63623872
    2- Minimum Observed Plasma Concentration (Cmin) of JNJ-63623872
    3- Maximum Observed Plasma Concentration (Cmax) of JNJ-63623872
    4- Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-63623872
    5- Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC [0-12])
    1- Punto mínimo de la concentración de plasma de JNJ-63623872
    2-Concentración mínima observada de JNJ-63623872 (Cmin)
    3-Concentración máxima observada de JNJ-63623872 (Cmax)
    4-Tiempo para alcanzar la concentración máxima observada de JNJ-63623872 (Tmax)
    5-Area bajo la curva de concentración plasmática-tiempo desde el momento de administración hasta 12h después de la dosis (AUC [0-12])
    E.5.1.1Timepoint(s) of evaluation of this end point
    1- Pre-dose, 1.5, 6 and 12 hours post-dose on Day 1; Predose, 1.5 and 6 hours post-dose on Day 2 and 4 to 7; Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3

    2- Pre-dose, 1.5, 6 and 12 hours post-dose on Day 1; Predose, 1.5 and 6 hours post-dose on Day 2 and 4 to 7; Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3

    3- same as above
    4- same as above
    5- same as above
    1- Antes de la dosis, 1.5, 6 y 12 horas después de la dosis en el Día 1, Antes de la dosis, 1.5, 6 después de la dosis en el Día 2 y 4 hasta el 7, Antes de la dosis 1, 2, 4, 6, 8, 10 y 12 horas después de la dosis en el Día 3
    2- Antes de la dosis, 1.5, 6 y 12 horas después de la dosis en el Día 1, 1.5 y 6 horas después de la dosis en el Día 2 y 4 hasta el 7; Antes de la dosis, 1, 2, 4, 6, 8, 10 y 12 horas después de la dosis en el Día 3

    3- igual que lo indicado anteriormente
    4- igual que lo indicado anteriormente
    5- igual que lo indicado anteriormente
    E.5.2Secondary end point(s)
    1- Time to Influenza Viral Negativity
    2- Viral Load Over Time
    3- Rate of Decline in Viral Load
    4- Area Under the Plasma Concentration-Time Curve (AUC) of Viral Load
    5- Disease Status and Incidence of Complications Associated With Influenza
    6- Change in Duration and Severity of Clinical Symptoms
    7- Time to Improvement of Vital Signs
    8- Time to Improvement of Respiratory Status
    9- Emergence of Drug Resistance
    10- Time to Return to Premorbid Functional Status
    11- Time to Hospital Discharge
    12- Time to Significant Reduction in Influenza Symptom Severity
    13- Percentage of Participants With a Significant Reduction to Mild or None for all Influenza Symptoms at Each Assessment
    14- Number of Participants with Adverse Events (AEs) and Serious AEs
    1- Tiempo que transcurre hasta la negatividad vírica para la gripe
    2- La carga vírica a lo largo del tiempo
    3- La tasa de disminución de la carga vírica
    4- Área bajo la curva (AUC) de la carga vírica
    5- El estado de la enfermedad, la incidencia de complicaciones asociadas con la gripe
    6- Modificación de la duración y la intensidad de los síntomas clínicos
    7- Tiempo hasta la mejoría de las constantes vitales
    8- Tiempo hasta la mejoría del estado respiratorio
    9- Aparición de resistencia farmacológica
    10- Tiempo hasta que regrese al estado funcional anterior a la enfermedad
    11- Tiempo hasta el alta hospitalaria
    12- Tiempo hasta la reducción significativa de la intensidad de los síntomas gripales
    13- La proporción de pacientes con una reducción significativa (hasta leve o ninguno para todos los síntomas gripales) en cada evaluación.
    14- Número de pacientes que presentan Eventos Adversos (AEs) y Eventos Adversos Graves.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 13- Up to Day 28

    14 - Screening up to followup (21 days after last dose administration)
    1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 13- hasta el día 28

    14- Selección hasta el seguimiento /21 días despues de la administración de la última dosis)
    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 Yes
    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
    - Tolerability
    - Biomarker analysis
    - Tolerabilidad
    - Análisis de biomarcadores
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Canada
    France
    Germany
    Hong Kong
    Netherlands
    Spain
    Sweden
    Turkey
    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
    Last patient last visit
    Último paciente última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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: 18
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 18
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 90
    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)
    See Protocol
    Ver protocolo
    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 Decision2015-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-15
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