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    Summary
    EudraCT Number:2017-002579-25
    Sponsor's Protocol Code Number:17-OBE022-003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-10-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-002579-25
    A.3Full title of the trial
    A phase 2a, double-blind, parallel group, randomised, placebo controlled, proof of concept study to assess the efficacy, safety and pharmacokinetics of OBE022 added-on to atosiban, after oral administration in pregnant women with threatened spontaneous preterm labour.
    Un estudio de prueba de concepto de fase 2a, doble ciego, de grupo paralelo, aleatorizado y controlado con placebo que evalúa la eficacia, la seguridad y la farmacocinética de OBE022 combinado con atosiban tras su administración por vía oral a mujeres embarazadas con amenaza de parto prematuro.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OBE022 added-on to atosiban in threatened spontaneous preterm labour, Proof of Concept study.
    OBE022 combinado con atosiban en amenaza de parto prematuro,
    estudio de PdC.
    A.3.2Name or abbreviated title of the trial where available
    PROLONG
    A.4.1Sponsor's protocol code number17-OBE022-003
    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 SponsorObsEva SA
    B.1.3.4CountrySwitzerland
    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 supportObsEva SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospiltal Universitario La Paz
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number34917277207
    B.5.6E-mailjoseluisbartha@me.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 nameOBE022
    D.3.2Product code OBE022
    D.3.4Pharmaceutical form Granules for oral suspension
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeOBE022
    D.3.9.3Other descriptive nameOBE022
    D.3.9.4EV Substance CodeSUB182291
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboGranules for oral suspension
    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
    oral treatment of threatened spontaneous preterm labour in weeks 24 to 34 of pregnancy
    tratamiento oral para la amenaza de parto prematuro en las semanas 24 a 34 del embarazo
    E.1.1.1Medical condition in easily understood language
    to delay imminent preterm birth in pregnant women
    para retrasar el parto prematuro inminente en mujeres embarazadas con amenaza
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10075863
    E.1.2Term Preterm labor
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    To evaluate the
    - maternal and fœtal safety and tolerability of OBE022
    - pharmacokinetics of OBE022/OBE002
    in pregnant women with threatened spontaneous preterm labour

    To describe
    - time to delivery
    - uterine contractions
    in pregnant women with threatened spontaneous preterm labour treated with OBE022

    Part B
    - To compare the efficacy of OBE022 to placebo to delay preterm birth
    - To evaluate the maternal and fœtal safety and tolerability of OBE022
    - To evaluate the pharmacokinetics of OBE022/OBE002
    - To assess the effect of OBE022 on uterine contractions
    in pregnant women with threatened spontaneous preterm labour
    Parte A:
    Evaluar
    - la seguridad de la madre y del feto y la tolerabilidad a OBE022
    - la farmacocinética de OBE022/OBE002
    en mujeres embarazadas con amenaza de parto prematuro

    Describir
    - el momento del parto
    - las contracciones uterinas
    en mujeres embarazadas con amenaza de parto prematuro tratadas con OBE022

    Parte B
    - Comparar la eficacia de OBE022 con el placebo para retrasar el parto prematuro
    - Evaluar la seguridad de la madre y del feto y la tolerabilidad a OBE022
    - Evaluar la farmacocinética de OBE022/OBE002
    - Evaluar el efecto de OBE022 en las contracciones uterinas
    en mujeres embarazadas con amenaza de parto prematuro
    E.2.2Secondary objectives of the trial
    Not applicable
    No procede
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A
    1. Provision of written informed consent to participate as shown by a signature on the patient consent form
    2. Be able and willing to comply with the requirements of the protocol
    3. Pregnant females aged > or = 18 years
    4. Patients with a singleton or twin pregnancy
    5. Gestational age between 28 (0/7) and 33 (6/7), as confirmed by a first trimester ultrasound scan or fertilization date. In situations where this information is not readily available, Investigator may use best clinical judgement or verbal history from the patient to be confirmed through medical records as soon as possible after randomization
    6. Administered or prescribed atosiban for the treatment of preterm labour (note that IMP treatment should be initiated ideally simultaneously or at a maximum within 24 h after atosiban start)

    Part B
    1. Provision of written informed consent to participate as shown by a signature on the patient consent form
    2. Be able and willing to comply with the requirements of the protocol
    3. Pregnant females aged > or = 18 years.
    4. Patients with a singleton or twin pregnancy
    5. Gestational age between 24 (0/7) and 33 (6/7), as confirmed by a first trimester US scan or fertilization date. In situations where this information is not readily available, the Investigator may use best clinical judgement or verbal history from the patient to be confirmed through medical records as soon as possible after randomization
    6. > or = 4 uterine contractions per 30 minutes, measured by electrohysterography, tocodynamometry or abdominal palpation
    7. Cervical dilatation of 1 to 4 cm inclusive
    8. At least one of the following consequences of preterm labour:
    a) positive IGFBP-1 or fœtal Fibronectin test
    b) cervical length < or = 25mm
    c) progressive cervical change
    9. Administered or prescribed atosiban for the treatment of preterm labour (note that IMP treatment should be initiated ideally simultaneously or at a maximum within 24 h after atosiban start)
    Parte A
    1. Disposición de un consentimiento informado por escrito para participar, según demuestra la firma del formulario de consentimiento de la paciente
    2. Capacidad y voluntad de cumplimiento de los requisitos del protocolo
    3. Mujeres embarazadas de edad igual o superior a 18 años
    4. Mujeres embarazadas de un solo bebé o de gemelos
    5. Edad gestacional entre la semana 28 (0/7) y la 33 (6/7) de embarazo, confirmado por una ecografía del primer trimestre o la fecha de embarazo. En situaciones en las que esta información no esté disponible, el investigador deberá usar su juicio clínico o la historia verbal de la paciente y se confirmará a través de su historia clínica tan pronto como sea posible y tras la aleatorización
    6. La administración o prescripción de atosiban para el tratamiento del parto prematuro (tenga en cuenta que el tratamiento con el PEI debe haberse iniciado simultáneamente o al menos en un máximo de 24 h después de haber empezado con atosiban)

    Parte B
    1. Disposición de un consentimiento informado por escrito para participar, según demuestra la firma del formulario de consentimiento de la paciente
    2. Capacidad y voluntad de cumplimiento de los requisitos del protocolo
    3. Mujeres embarazadas de edad igual o superior a 18 años.
    4. Mujeres embarazadas de un solo bebé o de gemelos
    5. Edad gestacional entre la semana 24 (0/7) y la 33 (6/7) de embarazo, confirmado por una ecografía del primer trimestre o la fecha de embarazo. En situaciones en las que esta información no esté disponible, el Investigador deberá usar su juicio clínico o la historia verbal de la paciente y se confirmará a través de su historia clínica tan pronto como sea posible y tras la aleatorización
    6. 4 o más contracciones uterinas cada 30 minutos, medidas por electrohisterografía, tocodinamometría o palpación abdominal
    7. Dilatación del cuello uterino de 1 cm a 4 cm, ambos inclusive
    8. Al menos una de las siguientes consecuencias por parto prematuro:
    a) IGFBP-1 positivo o prueba de fibronectina fetal
    b) longitud del cuello del útero menor o igual a 25 mm
    c) cambio cervical progresivo
    9. La administración o prescripción de atosiban para el tratamiento del parto prematuro (tenga en cuenta que el tratamiento con el PEI debe haberse iniciado simultáneamente o al menos en un máximo de 24 h después de haber empezado con atosiban)
    E.4Principal exclusion criteria
    To be eligible for inclusion in this study the patients must not meet any of the following criteria:
    1. Fœtal death in utero in current or previous pregnancy after gestational week 24 or expected high risk of fœtal death in the coming days
    2. Fœtal weight outside 2 standard deviations for GA based on ultrasound
    3. Oligohydramnios
    4. Pathological Doppler ultrasound of the umbilical artery
    5. Any contraindications for the mother or the fœtus to stop labour or prolong pregnancy or any maternal or fœtal conditions likely to indicate iatrogenic delivery in the next 7 days, including but not limited to:
    a) Premature rupture of membranes
    b) Evidence or suspicion of abruptio placenta
    c) Signs and/or symptoms of chorio-amnionitis
    d) Pre-eclampsia, eclampsia or HELLP-syndrome
    6. Any condition which in the opinion of the Investigator constitutes a risk or a contraindication for the participation of the patient in the trial or that could interfere with the trial objectives, conduct or evaluation, including:
    a) Any clinically significant abnormality in the results of the screening safety laboratory tests, including AST, ALT, GGT, alkaline phosphatase or total bilirubin > ×2 ULN for women taking into account gestational age
    b) Any clinically significant and trial relevant abnormality in the results of the screening physical examination including a gynaecological examination
    7. The patient has known positive results from virology tests for HBsAg (not due to vaccination), HCV or HIV 1 or 2. However, patients who have resolved hepatitis B infection may be enrolled in the study
    8. The patient had a BMI > or = 35 kg/m2 prior to start of current pregnancy or had a bariatric surgery
    9. Any condition likely to hinder drug absorption
    10. Use of cervical cerclage in the current pregnancy or a pessary in situ
    11. Current use of anti-hypertensive medication
    12. Treatment with other tocolytics within specified time before the baseline assessment of uterine contractions i.e.
    a) nifedipine (not long acting) in the previous 6 hours
    b) ritodrine, fenoterol, other betamimetics, indomethacin, other oral or injectable NSAIDs, long acting nifedipine, other calcium channel blockers, and nitric oxide donors in the previous 24 hours
    c) nicardipine in the previous 2 weeks
    13. Known allergy or hypersensitivity to the active substance or any of the ingredients of the study drug
    14. History of or current (within the past 12 months) known problem with alcohol or drug abuse
    15. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of uncooperative attitude
    16. Currently participating or have participated in another clinical trial (investigational drug or medical device) within 30 days prior to screening
    Las pacientes no deben cumplir cualquiera de los criterios siguientes si desean ser aptas para su inclusión en este estudio:
    1. Muerte fetal en el útero en el embarazo actual o en un embarazo previo tras la semana 24 de gestación o alto riesgo de muerte fetal en los siguientes días
    2. Peso del feto basado en las ecografías que esté fuera de las 2 desviaciones estándar de la EG
    3. Oligohidramnios
    4. Ecografía patológica Doppler de la arteria umbilical
    5. Cualquier contraindicación de la madre o del feto para detener el parto o alargarlo, o cualquier condición de la madre o del feto que puedan llevar a un parto iatrogénico en los próximos 7 días, incluidos entre otros:
    a) Ruptura prematura de las membranas
    b) Evidencia o sospecha de desprendimiento de la placenta
    c) Signos y/o síntomas de corioamnionitis
    d) Preeclampsia, eclampsia o síndrome HELLP
    6. Cualquier condición en la que la opinión del investigador signifique un riesgo o una contraindicación para la participación de la paciente en el estudio o que pudiera interferir con los objetivos, el desarrollo o la evaluación del estudio, incluyendo:
    a) Cualquier anomalía de importancia clínica en los resultados de las pruebas analíticas de seguridad de la fase de selección, incluyendo niveles de AST, ALT, GGT, fosfatasa alcalina o bilirrubina total por encima del doble LSN para mujeres, teniendo en cuenta la edad gestacional
    b) Cualquier anomalía de importancia clínica y relevante para el estudio en los resultados de la exploración física, incluyendo un examen ginecológico
    7. La paciente da resultados positivos en las pruebas virológicas para la detección del HBsAg (no debida a vacunación), VHC o VIH 1 o 2. Sin embargo, las pacientes en las que la infección por hepatitis B haya remitido podrán ser incluidas en el estudio
    8. La paciente tenía un IMC mayor o igual a 35 kg/m2 antes del inicio del embarazo o tuvo una cirugía bariátrica
    9. Cualquier condición que dificulte la absorción del fármaco
    10. Uso de cerclaje cervical en el embarazo actual o de un pesario in situ
    11. Uso actual de medicamentos antihipertensivos
    12. Tratamientos con otros tocolíticos en una cantidad de tiempo específica antes de la evaluación del valor de referencia de las contracciones uterinas, esto es:
    a) nifedipina (no de acción prolongada) en las 6 horas anteriores
    b) ritodrina, fenoterol, otros betamiméticos, indometacina, otros FAINE orales o inyectables, nifedipina de acción prolongada, bloqueadores de los canales de calcio y donantes de óxido nítrico en las 24 horas anteriores c. nicardipina en las dos semanas anteriores
    13. Alergia conocida o hipersensibilidad a los principios activos o cualquiera de los ingredientes del medicamento en (fase de) investigación
    14. Historial de antecedentes actuales conocidos (dentro de los últimos 12 meses) de alcoholismo o drogadicción
    15. Estado mental que deja a la paciente inhabilitada para entender la naturaleza, el alcance o las posibles consecuencias del estudio, y/o evidencia de una actitud poco cooperativa
    16. Haber participado o estar participando en otro ensayo clínico (fármaco en investigación o producto sanitario) dentro de los 30 días previos a la selección
    E.5 End points
    E.5.1Primary end point(s)
    As this study is a proof-of-concept study and the results as a whole will be used to inform the further clinical development of OBE022, a primary efficacy endpoint has not been defined.

    Efficacy End Point:
    • Incidence of delivery within 2 days (48 h) from start of IMP administration
    • Incidence of delivery within 7 days (168 h) from start of IMP administration
    • Incidence of delivery before 37 weeks of GA
    • Time to delivery measured from start of IMP administration

    Safety Endpoint:
    • Maternal incidence of AEs, TEAEs, clinically significant changes in laboratory safety tests, vital signs from Day 1 until 28 days after birth.
    • Incidence of AEs indicating fœtal distress such as growth retardation and/or changes in fœtal heart rate monitoring and/or amniotic fluid index (AFI) from Day 1 to Day 7 and Day 14 (or earlier if birth).
    • In Part A only: Incidence of fœtal adverse events in relation with the cardiovascular function assessed by Doppler ultrasound on Day 1 to 3 and Day 7 from IMP start.
    • Incidence of infants experiencing adverse events, clinical significant changes in vital signs. Apgar score, weight and head circumference at birth as well as a measure of neonatal morbidity from birth until 28 days after birth.
    • Incidence of infants with one or more Ages and Stages Questionnaire® domain score(s) below the cut-off score at 6 months, 12 months and 24 months of age, adjusted for gestational age at birth.

    PK Endpoint:
    • Plasma concentration of OBE022/OBE002 at Day 1, Day 2, Day 3 and Day 7.
    • Pharmacokinetic parameters of OBE022/OBE002 at Day 7: AUC, Cmax and half-life.
    • Fœtal (cord blood)-maternal exposure ratio at the time of delivery for patients who received IMP treatment within the previous 24 h.

    PD Endpoint:
    • Uterine contractions at each hour during the first 6 hours after IMP start.
    Debido a que este estudio es del tipo prueba de concepto y los resultados en su conjunto se utilizarán como información para el futuro desarrollo de OBE022, no se ha definido un objetivo principal de eficacia.

    Objetivo de eficacia:
    • Incidencia de parto en dos días (48 h) tras el comienzo de la toma de PEI
    • Incidencia de parto en siete días (168 h) tras el comienzo de la toma de PEI
    • Incidencia de parto antes de las 37 semanas de EG
    • Tiempo del momento del parto medido desde el inicio de la toma de PEI

    Objetivo de seguridad:
    • Incidencia maternal de los AA, AADT, cambios clínicamente significativos en los análisis de seguridad, constantes vitales desde el día 1 hasta el día 28 tras el nacimiento.
    • La incidencia de los AA que indican sufrimiento fetal, por ejemplo, retraso del crecimiento y/o cambios en la monitorización de la frecuencia cardíaca fetal y/o en el índice de líquido amniótico (ILA) desde el día 1 hasta el día 7 o 14 (o incluso antes si se produce el nacimiento).
    • Únicamente en la Parte A: Incidencia de acontecimientos adversos del feto relacionados con la función cardiovascular evaluada por ecografía Doppler desde el día 1 al día 3 y el día 7 desde el inicio del PEI.
    • Incidencia de bebés que experimentan acontecimientos adversos y cambios clínicos significativos en las constantes vitales. Test de Apgar, peso y perímetro cefálico al nacer, así como medida de morbilidad neonatal desde el nacimiento hasta 28 días después del parto.
    • Incidencia de bebés con una o más puntuaciones de los dominios del ASQ-3TM por debajo de los valores de corte a los 6, 12 y 24 meses de edad, ajustados a la edad gestacional en el momento del nacimiento.

    Objetivo de Farmacocinética:
    • Concentración en plasma de OBE022/OBE002 en el día 1, día 2, día 3 y día 7.
    • Parámetros farmacocinéticos de OBE022/OBE002 el día 7: ABC, Cmáx y vida media.
    • Ratio de exposición fetal (sangre del cordón) y maternal en el parto en pacientes que han recibido tratamiento con el PEI en las 24 h previas.

    Objectivo de Farmacodinámica:
    • Contracciones uterinas cada hora durante las seis primeras horas después del inicio del PEI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy, PK and PD:
    When the last patient has completed the 28 Day visit after Day of delivery

    Safety (Infant Follow-up):
    when the last infant has completed 24 month follow-up
    Eficacia, Farmacocinética y Farmacodinámica:
    Cuando el último paciente haya completado la visita del Día 28 tras el Día del parto

    Seguridad (Seguimiento del bebé):
    Cuando el bebé haya completado el periodo de seguimiento de 24 meses
    E.5.2Secondary end point(s)
    Not Applicable
    No procede
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No procede
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Finland
    Germany
    Israel
    Romania
    Russian Federation
    Spain
    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
    end of the Infant Follow-up.
    fin del seguimiento del bebé.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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 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: 130
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 130
    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
    ninguno
    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 Decision2018-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-29
    P. End of Trial
    P.End of Trial StatusOngoing
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