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    Summary
    EudraCT Number:2014-005260-15
    Sponsor's Protocol Code Number:FPCLI002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-10-05
    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 number2014-005260-15
    A.3Full title of the trial
    A Phase III Double-blind, Randomised, Parallel Group Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human Interferon Beta-1a) and Placebo in the Treatment of Patients with Moderate or Severe Acute Respiratory Distress Syndrome
    Estudio comparativo de fase III de grupos paralelos, aleatorizado y doble
    ciego sobre la eficacia y seguridad de FP-1201-lyo (interferón beta-1A
    recombinante humano) y placebo en el tratamiento de pacientes con
    síndrome de dificultad respiratoria aguda grave o moderado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) in patients having acute respiratory distress syndrome (ARDS)
    Un estudio para evaluar la eficacia y la seguridad del nuevo fármaco FP-
    1201-lyo (interferón beta-1A recombinante humano) en pacientes con
    síndrome de dificultad respiratoria aguda (SDRA)
    A.3.2Name or abbreviated title of the trial where available
    INTEREST study
    A.4.1Sponsor's protocol code numberFPCLI002
    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 SponsorFaron Pharmaceuticals Ltd
    B.1.3.4CountryFinland
    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 supportFaron Pharmaceuticals Ltd
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Santa Creu i Sant Pau
    B.5.2Functional name of contact pointNational Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressSant Quintí, 89
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08026
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493553 7238
    B.5.6E-mailJMancebo@santpau.cat
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/505
    D.3 Description of the IMP
    D.3.1Product nameTraumakine
    D.3.2Product code FP-1201-lyo
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    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 INNInterferon beta-1a
    D.3.9.1CAS number 220581-49-7
    D.3.9.2Current sponsor codeFP-1201
    D.3.9.4EV Substance CodeSUB12440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typePre-filled syringe containing 1.0 ml water for injection for reconstitue lyophilised IMP.
    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 placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult patients diagnosed with moderate or severe Acute Respiratory Distress Syndrome (ARDS)
    Pacientes adultos diagnosticados de Síndrome de Dificultad Respiratoria
    Aguda (SDRA) moderado o grave.
    E.1.1.1Medical condition in easily understood language
    Adult acute respiratory failure.
    Dificultad respiratoria aguda en adultos
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10003083
    E.1.2Term ARDS
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of FP-1201-lyo in improving the clinical course and outcome based on survival and need for mechanical ventilation in patients with moderate or severe acute respiratory distress syndrome (ARDS)
    Demostrar la eficacia de FP-1201-lyo a la hora de mejorar el curso clínico y los desenlaces en función de la supervivencia y la necesidad de ventilación mecánica en pacientes con SDRA moderado o grave.
    E.2.2Secondary objectives of the trial
    Safety
    - the safety of FP-1201-lyo compared with placebo

    Efficacy
    - 28-day all-cause mortality of FP-1201-lyo compared with placebo
    - all-cause mortality at other selected time points
    - the efficacy of FP-1201-lyo compared with placebo by assessing:
    ­ - days free of organ failure, of renal support, of vasoactive support, of mechanical ventilation and number of intensive care unit (ICU) -free days
    ­ - number of days in hospital
    - the immunogenicity
    - the pharmacodynamics (PD) of FP-1201-lyo with myxovirus resistance protein A (MxA)
    - patient outcomes for respiratory and neurological functioning and quality of life (QoL)

    Pharmacoeconomics
    - selected parameters

    Exploratory
    - gas exchange during mechanical ventilation
    - the PD of FP-1201-lyo using the (CD)73 biomarker
    - selected potential inflammatory markers (PIM)
    - Blood sample for future pharmacogenetic analysis
    - all-cause mortality, QoL, and respiratory and neurological functioning follow-up (Day 360)
    Seguridad:
    - la seguridad de FP-1201-lyo comparada con la del placebo
    Eficacia
    - mortalidad por cualquier causa a los 28 días
    - mortalidad por cualquier causa en otros puntos determinados
    - eficacia de FP-1201-lyo versus placebo, mediante la evaluación de:
    -Días sin fallo orgánico.sin soporte renal, sin mantenimento vasoactivo,
    sin ventilación mecánica, sin estancia en la UCI, número de días en
    hospital
    - Inmunogenicidad
    - Farmacodinámica (FD) de FP-1201-lyo con la proteína de resistencia a
    mixovirus (MxA)
    -los desenlaces del paciente en cuanto a función respiratoria y
    neurológica y calidad de vida (CdV)
    Farmacoeconómicos
    - parámetros seleccionados
    Exploratorios
    - intercambio gaseoso durante la ventilación mecánica
    - FD mediante el uso del biomarcador CD73
    - Marcadores inflamatorios seleccionados
    - Muestra de sangre para análisis farmacogenético
    - Mortalidad por cualquier causa, la CdV y la función respiratoria y
    neurológica a largo plazo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient has a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS:
    1.1 Acute onset of respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms
    1.2 Respiratory failure associated with known ARDS risk factors and not fully explained by either cardiac failure or fluid overload (an objective assessment of cardiac failure or fluid overload is needed if no risk factors for ARDS [moderate or severe ARDS] are present)
    1.3 Radiological abnormalities on chest X-ray or on computerised tomography scan, i.e., bilateral opacities, that are not fully explained by effusions, nodules, masses or lobar/lung collapse
    1.4 Hypoxaemia:
    -Moderate ARDS: PaO2/FiO2 >100 mmHg (>13.3 kPa) to ?200 mmHg (?26.6 kPa) with positive end expiratory pressure (PEEP) ?5 cmH2O
    - Severe ARDS: PaO2/FiO2 ?100 mmHg (?13.3 kPa) with PEEP ?5 cmH2O
    2. The radiological and hypoxaemia criteria (1.3 and 1.4) must be met within the same 24-hour period. The time of onset of ARDS is when the last of the two specified ARDS criteria is met
    3. Administration of the first dose of study drug must be planned to take place within 48 hours of first fulfilling the above inclusion criteria
    4. Patient is intubated and mechanically ventilated
    5. A signed informed consent form from the patient or the patient?s personal legal representative or a professional legal representative must be available
    6. Patient is aged ?18 years
    1.El paciente tiene un diagnóstico de SDRA moderado o grave según la definición de SDRA de Berlín4:
    1.1 Inicio agudo de insuficiencia respiratoria en el plazo de 1 semana tras una lesión clínica conocida o la aparición o el empeoramiento de síntomas respiratorios
    1.2 Insuficiencia respiratoria asociada a factores de riesgo de SDRA conocidos y que no se pueda atribuir por completo a una insuficiencia cardiaca o a la hipervolemia (se necesita una evaluación objetiva de la insuficiencia cardiaca o de la hipervolemia si no hay factores de riesgo de SDRA [SDRA moderado o grave])
    1.3 Anomalías radiológicas en la radiografía de tórax o en la tomografía axial computarizada (TAC), es decir, opacidad bilateral que no se explique por completo por derrames, nódulos, masas o colapso lobular/pulmonar.
    1.4 Hipoxemia:
    - SDRA moderado: valor de PaO2/FiO2 > 100 mmHg (> 13,3 kPa) hasta 200 mmHg (? 26,6 kPa) con presión telespiratoria positiva (PEEP) ? 5
    cm H2O
    - 1.4. SDRA grave: PaO 2 /FiO 2 ? 100 mmHg (? 13,3 kPa) con PEEP ? 5 cm H2O
    2. Los criterios radiológicos y de hipoxemia (1.3 y 1.4) pueden tener lugar durante el mismo periodo de 24 horas. El momento de inicio del SDRA es el momento en que se cumple el último de los dos criterios especificados
    3. La administración de la primera dosis del fármaco del estudio debe
    programarse para que tenga lugar en un periodo de 48 horas después de
    que se cumplan los criterios de inclusión anteriores
    4. El paciente está intubado y con ventilación mecánica
    5. Debe estar disponible un consentimiento informado por escrito
    firmado por el paciente o el representante legal personal del paciente
    (PerLR) o por un representante legal profesional (PrfLR).
    6.El paciente tiene ? 18 años de edad
    E.4Principal exclusion criteria
    1. Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test
    2. Patient is simultaneously taking part in another pharmacotherapy protocol
    3. Patient is not expected to survive for 24 hours
    4. Patient has an underlying clinical condition where, in the opinion of the Investigator, it would be extremely unlikely that the patient would come off ventilation, e.g., motor neurone disease, Duchenne muscular dystrophy, or rapidly progressive interstitial pulmonary fibrosis
    5. Patient has severe chronic obstructive pulmonary disease requiring long-term home oxygen therapy or mechanical ventilation (non-invasive ventilation or via tracheotomy) except for continuous positive airway pressure (CPAP) or bi-level positive airway pressure used solely for sleep-disordered breathing
    6. Patient has congestive heart failure, defined as New York Heart Association class IV
    7. Patient has acute left ventricular failure
    8. Patient has liver failure (Child-Pugh grade C)
    9. Patient has received prior interferon
    10. Patient has known hypersensitivity to natural or recombinant IFN beta or to any of the excipients
    11. Patient is receiving renal dialysis therapy for chronic renal failure
    12. Patient is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support
    13. Patient has had any form of mechanical ventilation (invasive or non-invasive, excluding CPAP alone) for longer than 48 hours prior to the diagnosis of ARDS
    Non-invasive ventilation has to be continuously applied for at least 12 hrs per day in these 48 hours
    14. Patient has burns to ?15% of their total body surface area
    1. Mujeres embarazadas, lactantes o con un test de embarazo positivo (prueba en suero u orina) o indeterminado (prueba en suero).
    2. El paciente forma parte simultáneamente de otro protocolo farmacoterapéutico.
    3. No se espera que el paciente sobreviva más de 24 horas.
    4. El paciente presenta una enfermedad clínica subyacente por la que, en opinión del investigador, sería muy improbable que el paciente pudiera dejar la ventilación, p. ej., enfermedad de la motoneurona, distrofia muscular de Duchenne o fibrosis pulmonar intersticial de progresión rápida.
    5. El paciente padece una enfermedad pulmonar obstructiva crónica grave que requiere oxigenoterapia domiciliaria a largo plazo o ventilación mecánica (ventilación no invasiva o por traqueotomía), a excepción de la presión positiva continua en la vía aérea (CPAP) o la presión positiva de dos niveles en la vía aérea (BIPAP), métodos destinados exclusivamente a trastornos respiratorios del sueño.
    6. El paciente presenta insuficiencia cardiaca congestiva de clase IV, según la New York Heart Association.
    7. El paciente presenta insuficiencia ventricular izquierda aguda.
    8. El paciente presenta insuficiencia hepática (grado C en la escala Child
    Pugh).
    9. El paciente ha recibido IFN con anterioridad.
    10. El paciente presenta hipersensibilidad conocida a IFN beta natural o recombinante o a alguno de los excipientes.
    11. El paciente está bajo tratamiento con diálisis renal por insuficiencia renal crónica.
    12. El paciente está recibiendo oxigenación por membrana extracorpórea, ventilación de alta frecuencia oscilatoria (VAFO) o cualquier forma de asistencia respiratoria extracorpórea.
    13. El paciente ha recibido cualquier forma de ventilación mecánica (invasiva o no invasiva, a excepción de la CPAP sola) durante más de 48 horas antes del diagnóstico del SDRA.
    La ventilación no invasiva debe aplicarse de forma continua durante al menos 12 horas al día en estas 48 horas.
    14. El paciente presenta quemaduras en ? 15 % de la superficie corporal.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    -Composite endpoint including any cause death at D28 and days free of mechanical ventilation (VFDsurv) within 28 days among survivors
    Criterio de valoración principal de eficacia:
    - Criterio de valoración compuesto, que incluye muerte por cualquier
    causa antes del D28 y días sin ventilación mecánica (VFDsurv) en los 28
    días entre los supervivientes
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    Día 28
    E.5.2Secondary end point(s)
    *Secondary efficacy endpoints relating to the efficacy of FP-1201-lyo treatment:
    - All-cause mortality at D28, D90 and D180
    - Mortality in ICU up to D28
    - Mortality in hospital up to D28
    * Other secondary efficacy endpoints at D28:
    - Days free of organ failure (Sequential Organ Failure Assessment methodology)
    - Days free of renal support
    - Days free of vasoactive support
    - Days free of mechanical ventilation
    - Number of ICU free days
    - Number of days in hospital
    * Presence of neutralising antibodies to IFN beta-1a at baseline and D28 (or last day in ICU or at withdrawal, if earlier)
    * Evaluation of PD using MxA biomarker from baseline to D14
    * Long-term secondary endpoints, relating to QoL, respiratory and neurological functioning at D180:
    - EQ-5D-3L
    - 6MWT
    - FEV1

    Evaluation of safety:
    - Adverse events up to D28
    - Physical examination, vital signs and laboratory results (biochemistry, haematology and urinalysis) up to D28

    Evaluation of pharmacoeconomics at D28:
    - Days free of organ failure
    - Days free of renal support
    - Days free of vasoactive support
    - Days free of mechanical ventilation
    - Number of ICU-free days
    - Number of days in hospital

    Exploratory endpoints relating to the efficacy of FP-1201-lyo treatment:
    - Composite endpoint including mortality and days free of mechanical ventilation (VFDsurv) within 90 days among survivors
    - Ordered categorical endpoint defined as improvement (severe to moderate/mild; from moderate to mild ARDS), no change or worsening (from moderate to severe/death; from severe to death) in terms of gas exchange (PaO2/FiO2 ratio) from baseline to D28

    - Change in the treatment-specific exploratory biomarker CD73 concentration from baseline to D14
    - Changes in levels of PIMs, including but not limited to, interleukin-6 and -8 from baseline to D14
    - A blood sample will be taken for pharmacogenetic analysis and correlation with other markers of the activity of FP-1201-lyo
    - Extended long-term follow-up: 12-month mortality rate, EQ-5D-3L, 6MWT and FEV1
    * Criterios secundarios de valoración relativos a la eficacia del tratamiento con FP-1201-lyo:
    Mortalidad por todas las causas el D28, D90 y D180
    Mortalidad en la UCI hasta el D28
    Mortalidad en el hospital hasta el D28
    * Otros criterios de valoración de la eficacia el D28:
    -Días sin fallo orgánico (metodología SOFA [Sequential Organ Failure
    Assessment])
    -Días sin ayuda a la función renal
    -Días sin mantenimiento vasoactivo
    -Días sin ventilación mecánica
    -Números de días sin estancia en la UCI
    -Número de días en el hospital
    * Presencia de anticuerpos neutralizantes de IFN beta-1A en el periodo
    basal y el D28 (o en el último día en la UCI o en la retirada, si es antes).
    *Evaluación de la FD utilizando biomarcadores de MxA desde el periodo
    basal hasta el D14.
    * Criterios secundarios de valoración a largo plazo, relacionados con la
    CdV y la función respiratoria y neurológica el D180:
    -EQ-5D-3L
    -PM6M
    -VEMS
    Evaluación de la seguridad
    - Acontecimientos Adversos hasta el D28
    - Exploración física, constantes vitales y resultados analíticos
    (bioquímica, hematología y análisis de orina) hasta el D28.
    Evaluación de la farmacoeconomía el D28:
    - Días sin fallo orgánico
    - Días sin ayuda a la función renal
    - Días sin mantenimiento vasoactivo
    - Días sin ventilación mecánica
    - Números de días sin estancia en la UCI
    - Número de días en el hospital.
    Evaluación de las variables exploratorias
    - Criterios de valoración exploratorios relativos a la eficacia del
    tratamiento con FP-1201-lyo:
    -Criterio de valoración compuesto, que incluye la mortalidad y los días
    sin ventilación mecánica (VFDsurv) en los 90 días entre los
    supervivientes
    -Criterios de valoración categóricos ordenados definidos como una
    mejoría (de SDRA grave a moderado/leve o de moderado a leve), sin
    cambio o empeoramiento (de moderado a grave/muerte o de grave a la
    muerte) en términos de intercambio gaseoso (cociente PaO2/FiO2)
    desde del periodo basal al D28.
    - Cambio en la concentración del biomarcador exploratorio CD73
    específico del tratamiento desde el periodo basal hasta el D14
    - Cambio en los niveles de PMI, incluidos entre otros, interleucina 6 y 8
    desde el periodo basal hasta el D14.
    - Se tomará una muestra de sangre para realizar análisis
    farmacogenéticos y de la correlación con otros marcadores de la
    actividad de FP-1201-lyo
    - Periodo de seguimiento a largo plazo ampliado: tasa de mortalidad de
    12 meses, EQ-5D-3L, PM6M y VEMS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    D14, D28, D90, D180 and D360
    D14, D28, D90, D180 y D360
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    Calidad de vida
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Ultima visita del último paciente
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patient treatment in ICU unit - availability of the legal representative
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    None. According to normal practice.
    Ninguno. De acuerdo a la práctica habitual.
    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 Decision2015-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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