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    Summary
    EudraCT Number:2016-000343-14
    Sponsor's Protocol Code Number:AS0007
    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:2016-07-15
    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 number2016-000343-14
    A.3Full title of the trial
    Multicenter, Open-Label Study To Assess The Effects Of Certolizumab Pegol On The Reduction Of Anterior Uveitis Flares In Axial Spondyloarthritis Subjects With A History Of Anterior Uveitis (C-VIEW)
    ESTUDIO MULTICÉNTRICO ABIERTO PARA EVALUAR LOS EFECTOS DEL CERTOLIZUMAB PEGOL EN LA REDUCCIÓN DE LAS CRISIS DE UVEÍTIS ANTERIOR EN PACIENTES CON ESPONDILOARTRITIS AXIAL CON ANTECEDENTES DE UVEÍTIS ANTERIOR (C-VIEW)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares In Axial Spondyloarthritis Subjects With A documented History of AU
    Estudio para evaluar los efectos de Certolizumab Pegol en la reducción de brotes de Uveitis Anterior (UA) en pacientes con Espondiloartritis Axial con antedecentes documentados de UA.
    A.3.2Name or abbreviated title of the trial where available
    C-VIEW
    C-View
    A.4.1Sponsor's protocol code numberAS0007
    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 SponsorUCB Biopharma SPRL.
    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 supportUCB Biopharma SPRL.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointCT Registries & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 CIMZIA certolizumab pegol 200 mg/ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCERTOLIZUMAB PEGOL
    D.3.9.1CAS number 428863-50-7
    D.3.9.2Current sponsor codeCDP870
    D.3.9.4EV Substance CodeSUB25423
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 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 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
    Anterior Uveitis (AU) in subject with Axial Spondyloarthritis (axSpA) and a history of AU.
    Uveitis Anterior (UA) en pacientes con espondiloartritis axial (axSpA) y antecedentes de UA
    E.1.1.1Medical condition in easily understood language
    Anterior Uveitis is an inflammation of the middle layer of the eye. Axial
    Spondyloarthritis is a chronic inflammatory disease predominantly
    affecting the axial skeleton(sacroiliac joints
    and spine)
    Uveitis Anterior es inflamación de la capa media del ojo.Espondiloartritis axial es una enfermedad crónica inflamatoria que afecta sobre todo al esqueleto axial( articulaciones sacroiliacas y columna)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level SOC
    E.1.2Classification code 10028395
    E.1.2Term Musculoskeletal and connective tissue disorders
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the effect of Certolizumab Pegol(CZP) treatment on the reduction of Anterior Uveitis(AU) flares in subjects with active Axial Spondyloarthritis (axSpA) and a documented history of AU.
    Demostrar el efecto del tratamiento con Certolizumab pegol (CZP)en la reducción de las crisis de Uveitis Anterior (UA) en pacientes con Espondiloartritis axial (axSpA) activa y antecedentes documentados de UA.
    E.2.2Secondary objectives of the trial
    -To assess the effect of Certolizumab Pegol (CZP) treatment on
    the reduction of Anterior Uveitis (AU) flares in subjects with active Axial Spondyloarthritis (axSpA) having at least 1 documented history of AU within 12 months prior to Baseline.
    - To assess the effect of Certolizumab Pegol (CPZ) treatment on AxSpA disease activity.
    -Evaluar el efecto del tratamiento con Certolizumab Pegol (CZP) en la reducción de las crisis de Uveitis Anterior(UA) en pacientes con Espondiloartritis axial (axSpA) que tengan al menos 1 antecedente documentado de UA en los 12 meses anteriores al inicio .

    -Evaluar el efecto del tratamiento con Certolizumab Pegol (CZP) en
    la actividad de la axSpA .
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects must have a documented diagnosis of adult-onset axial
    Spondyloarthritis (axSpA) with at
    least 3 months' symptom duration and meet the Assessment of
    SpondyloArthritis International Society
    (ASAS) criteria
    2) Subjects must have active disease at Screening as defined by
    - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >=
    4
    - Spinal pain >= 4 on a 0 to 10 Numerical Rating Scale (NRS; from
    BASDAI item 2)
    - Nonradiographic (Nr)-axSpA subjects must either have C-reactive
    protein (CRP) > upper limit of
    normal (ULN) and /or current evidence of sacroiliitis on magnetic
    resonance imaging (MRI) taken within
    3 months prior to Baseline (no confirmation by central reading) as
    defined by ASAS criteria
    - Ankylosing spondylitis (AS) subjects must have evidence of sacroiliitis
    on x-ray taken within 12
    months prior to Baseline meeting modified New York (mNY) criteria
    according to the Investigator
    3) Subjects must have a documented history of Anterior Uveitis (AU)
    diagnosed by an ophthalmologist
    and have at least 2 AU flares in the past, of which at least 1 AU flare was
    in the last 12 months prior to
    Baseline
    1)Los pacientes deber tener un diagnostico documentado de axSpA de aparición en la edad adulta con duración mínima de síntomas de 3 meses y que cumplan con los criterios de Assessment of
    SpondyloArthritis International Society
    ( ASAS )
    2) Los pacientes deben tener enfermedad activa en la selección definida por:
    -Puntuación Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4
    Dolor Espinal >=4 en una Escala Analógica Visual (EVA) de 0 a 10 ( en el item 2 de BASDAI)
    Los pacientes con axSpA-(NR) no radiológica a deben presentar Prot C r > (LSN) y/o evidencia actual de sacroileítis en resonancia Mágnetica (RM) tomada en los 3 meses anteriores al inicio (sin confirmación de lectura central) de acuerdo con los criterios ASAS.
    los pacientes con (AS)spondilitis anquilosante deben presentar evidencia de sacroileítis en Rayos X tomada en los 12 meses anteriores al inicio que cumpla los criterios modificados de Nueva York (mNY) según el investigador.
    3).Los pacientes deben tener antecedentes documentados de Uveitis Anterior (UA) diagnosticada por un oftalmólogo y haber tenido al menos 2 crisis de UA, al menos 1 de ellas en los 12 meses anteriores al inicio.
    E.4Principal exclusion criteria
    - Other inflammatory arthritis
    - Secondary, noninflammatory condition that, in the Investigator's
    opinion, is symptomatic enough to interfere with evaluation of the effect
    of study drug on the subject's primary diagnosis of axial
    spondyloarthritis (axSpA)
    - Any history of uveitis except for Anterior Uveitis (AU) associated with
    axSpA
    - Any condition or complicating factor that may interfere with the AU
    assessment
    - Retisert or Iluvien (glucocorticosteroid implant) within 3 years prior
    to the Baseline Visit or has had complications related to the device
    - Subject has had Retisert or Iluvien (glucocorticosteroid implant)
    removed within 90 days prior to the Baseline Visit
    - Intraocular or periocular corticosteroids within 90 days prior to the
    Baseline visit
    - Ozurdex (dexamethasone implant) within 6 months prior to the
    Baseline Visit
    - Cyclophosphamide within 30 days prior to the Baseline Visit
    - Intravitreal methotrexate (MTX) within 90 days prior to the Baseline
    Visit
    - Intravitreal anti-vascular endothelial growth factor (VEGF) therapy
    - Otra artritis inflamatoria- - Condición no inflamatoria, , secundaria, que en opinión del Investigador, sea suficientemente sintomática para interferir con la evaluación del efecto del fármaco del estudio en el diagnóstico primario del paciente de espondiloartritis (axSpA).
    -Cualquier historia de uveitis que no sea por Uveitis Anterior (UA) asociada a axSpA.
    -Cualquier condición o factor de complicación que pueda interferir con la evaluación de la Uveitis Anterior (UA)
    -Retisert o Iluvien (implante de glucocorticoesteorides) en los 3 años previos la visita Basal o que haya tenido complicacionnes relacionadas con el dispositivo-
    - se le haya retirado al paciente Retisert o Iluvien (implante de glucocorticoesteorides) en los 90 días antes de la Visita Basal.
    -Corticoesteroides intraoculares o perioculares en los 90 días previos la Visita Basal.
    -Ozurdex (implante de dexametasona) en los 6 meses previos a la Visita Basal.
    -Ciclofosfamida en los 30 días previos a la Visita Basal.
    -Metrotrexato intravitreal (MTX) en los 90 días previos a la Visita Basal.
    -Terapia con Factor de crecimiento endotelial antivascular intravitreal (VEGF)
    E.5 End points
    E.5.1Primary end point(s)
    Number of distinct episodes of anterior uveitis (AU) flares during the
    Treatment Period
    Número de los distintos episodios de de los brotes de Uveitis Anterior (UA) durante el Periodo de Tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the Treatment Period up to 96 weeks
    Durante el Período de Tratamiento hasta 96 semanas.
    E.5.2Secondary end point(s)
    1. Number of Anterior Uveitis (AU) flares per 100 patient-years in
    subjects with active axial
    Spondyloarthritis (axSpA) and a history of AU at Week 48
    2. Number of Anterior Uveitis (AU) flares per 100 patient-years in
    subjects with active axial
    Spondyloarthritis (axSpA) and a history of AU at Week 96
    3. Number of Anterior Uveitis (AU) flares per 100 patient-years in
    subjects with active axial
    Spondyloarthritis (axSpA) and at least 1 AU episode within 12 months
    prior Baseline at Week 48
    4. Number of Anterior Uveitis (AU) flares per 100 patient-years in
    subjects with active axial
    Spondyloarthritis (axSpA) and at least 1 AU episode within 12 months
    prior Baseline at Week 96
    5. Change from Baseline in Ankylosing Spondylitis Disease Activity Score
    (ASDAS) at Week 48
    6. Change from Baseline in Ankylosing Spondylitis Disease Activity Score
    (ASDAS) at Week 96
    7. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity
    Index (BASDAI) at Week 48
    8. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity
    Index (BASDAI) at Week 96
    9. Percentage of subjects with Axial Spondyloarthritis International
    Society 20 % response criteria
    (ASAS20) at Week 48
    10. Percentage of subjects with Axial Spondyloarthritis International
    Society 20 % response criteria
    (ASAS20) at Week 96
    11. Percentage of subjects with Axial Spondyloarthritis International Society 40 % response criteria
    (ASAS40) at Week 48
    12. Percentage of subjects with Axial Spondyloarthritis International
    Society 40 % response criteria
    (ASAS40) at Week 96
    13. Percentage of subjects with Axial Spondyloarthritis International
    Society (ASAS) 5/6 response at
    Week 48
    14. Percentage of subjects with Axial Spondyloarthritis International
    Society (ASAS) 5/6 response at
    Week 96
    15. Percentage of subjects with Axial Spondyloarthritis International
    Society (ASAS) partial remission
    (PR) response at Week 48
    16. Percentage of subjects with Axial Spondyloarthritis International
    Society (ASAS) partial remission
    (PR) response at Week 96
    17. Change from Baseline in tender joint count (44 joint count) at Week
    48
    18. Change from Baseline in tender joint count (44 joint count) at Week
    96
    19. Change from Baseline in swollen joint count (44 joint count) at Week
    48
    20. Change from Baseline in swollen joint count (44 joint count) at Week
    96
    21. Change From Baseline in Physician's Global Assessment of Disease
    Activity (PhGADA) at Week 48
    22. Change From Baseline in Physician's Global Assessment of Disease
    Activity (PhGADA) at Week 96
    23. Change From Baseline in Patient's Global Assessment of Disease
    Activity (PtGADA) at Week 48
    24. Change From Baseline in Patient's Global Assessment of Disease
    Activity (PtGADA) at Week 96
    25. Change from Baseline in total spinal pain at Week 48 assessed by
    Numerical Rating Scale (NRS)
    26. Change from Baseline in total spinal pain at Week 96 assessed by
    Numerical Rating Scale (NRS)
    27. Change from Baseline to Week 48 in the Bath Ankylosing Spondylitis
    Functional Index (BASFI)
    28. Change from Baseline to Week 96 in the Bath Ankylosing Spondylitis
    Functional Index (BASFI)
    29. Change from Baseline to Week 48 in Inflammation assessed by the
    mean of the Bath Ankylosing
    Spondylitis Disease Activity Index (BASDAI) questions 5 and 6
    concerning morning stiffness and
    duration
    30. Change from Baseline to Week 96 in Inflammation assessed by the
    mean of the Bath Ankylosing
    Spondylitis Disease Activity Index (BASDAI) questions 5 and 6
    concerning morning stiffness and
    duration
    1. Número de crisis de UA por 100 años-paciente en pacientes con axSpA activa y antecedentes de UA en la semana 48
    2. Número de crisis de UA por 100 años-paciente en pacientes con axSpA activa y antecedentes de UA en la semana 96
    3. Número de crisis de UA por 100 años-paciente en pacientes con axSpA activa y al menos un episodio de UA en los 12 meses anteriores al inicio en la semana 48
    4. Número de crisis de UA por 100 años-paciente en pacientes con axSpA activa y al menos un episodio de UA en los 12 meses anteriores al inicio en al semana 96
    5. Cambios con respecto al valor inicial en la Puntuación de la Actividad de la Espondilitis Anquilosante (ASDAS) en la semana 48.
    6. Cambios con respecto al valor inicial en la Puntuación de la Actividad de la Espondilitis Anquilosante (ASDAS) en la semana 96
    7. Cambios con respecto al valor inicial en el Índice de Actividad de la Espondilitis Anquilosante de Bath (BASDAI) en la semana 48
    8. Cambios con respecto al valor inicial en el Índice de Actividad de la Espondilitis Anquilosante de Bath (BASDAI) en la semana 96
    9. Porcentaje de sujetos con Con criterio de respuesta ASAS del 20% (ASAS20) en la semana 48.
    10. Porcentaje de sujetos con Con criterio de respuesta ASAS del 20% (ASAS20) en la semana 96.
    11. Porcentaje de sujetos con Con criterio de respuesta ASAS del 40% (ASAS40) en la semana 48
    12. Porcentaje de sujetos con Con criterio de respuesta ASAS del 40% (ASAS40) en la semana 96
    13. Porcentaje de sujetos con Con criterio de respuesta ASAS de 5/6 (ASAS ) en la semana 48
    14. Porcentaje de sujetos con Con criterio de respuesta ASAS de 5/6 (ASAS ) en la semana 96
    15. Porcentaje de sujetos con Con criterio de respuesta ASAS de remisión parcial (ASAS ) en la semana 48
    16. Percentage of subjects with Axial Spondyloarthritis International
    Society (ASAS) partial remission
    (PR) response at WeekPorcentaje de sujetos con Con criterio de respuesta ASAS de remisión parcial (ASAS ) en la semana 96
    17. Cambios con respecto al valor inicial en el recuento de articulaciones sensibles (recuento de 44 articulaciones) en la semana 48
    18. Cambios con respecto al valor inicial en el recuento de articulaciones sensibles (recuento de 44 articulaciones) en la semana
    96
    19. Cambios con respecto al valor inicial en el recuento de articulaciones inflamadas (recuento de 44 articulaciones) en la semana
    48
    20. Cambios con respecto al valor inicial en el recuento de articulaciones inflamadas (recuento de 44 articulaciones) en la semana
    96
    21. Cambios con respecto al valor inicial en la Evaluación general de la actividad de la enfermedad por parte del médico (PhGADA) en la semana 48
    22. Cambios con respecto al valor inicial en la Evaluación general de la actividad de la enfermedad por parte del médico (PhGADA) en la semana 96
    23. Cambios con respecto al valor inicial en la Evaluación general de la actividad de la enfermedad por parte del paciente(PtGADA) en la semana 48
    24. Cambios con respecto al valor inicial en la Evaluación general de la actividad de la enfermedad por parte del paciente(PtGADA) en la semana 96.
    25. Cambios con respecto al valor inicial de la Evaluación del dolor (Escala de Puntuación Numérica [EPN] de dolor espinal total en la semana 48.
    26. Cambios con respecto al valor inicial de la Evaluación del dolor (Escala de Puntuación Numérica [EPN] de dolor espinal total en la semana 96
    27. Cambios desde el inicio a la semana 48 en Función (representada por el Índice Funcional de la Espondilitis Anquilosante de Bath [BASFI])
    28. Cambios desde el inicio a la semana 96 en Función (representada por el Índice Funcional de la Espondilitis Anquilosante de Bath [BASFI])
    29. Cambios desde el inicio a la semana 48 en la Inflammación evaluado como la media preguntas 5 y 6 del BASDAI acerca de la rigidez matutina y la duración).
    30.Cambios desde el inicio a la semana 96 en la Inflammación evaluado como la media preguntas 5 y 6 del BASDAI acerca de la rigidez matutina y la duración).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3: During the Treatment Period up to 48 weeks.
    2, 4: During the Treatment Period up to 48 weeks.
    5, 7, 17, 19, 21, 23, 25, 27, 29: From Baseline to Week 48.
    6, 8, 18, 20, 22, 24, 26, 28, 30: From Baseline to Week 96.
    9, 11, 13, 15: Week 48
    10, 12, 14, 16: Week 96
    1, 3: Durante el tratamiento y hasta 48 semanas.
    2, 4:Durante el tratamiento y hasta 48 semanas.
    5, 7, 17, 19, 21, 23, 25, 27, 29: Desde el inicio a Semana 48
    6, 8, 18, 20, 22, 24, 26, 28, 30: Desde el inicio a Semana 96
    9, 11, 13, 15: Semana 48
    10, 12, 14, 16: Semana 96
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last subject Last Visit(LSLV)
    Ultima Visita del Ultimo Paciente (UVUP)
    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: 86
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 86
    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)
    Not applicable
    No aplica
    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 Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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