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    Summary
    EudraCT Number:2010-023802-10
    Sponsor's Protocol Code Number:B1801023
    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:2011-07-12
    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 number2010-023802-10
    A.3Full title of the trial
    AN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014)
    Estudio abierto de extensión para evaluar la seguridad a largo plazo de Etanercept en niños y adolescentes con artritis idiopática juvenil oligoarticular extendida, artritis asociada a entesitis o artritis psoriásica, que participaron anteriormente en el protocolo 0881A1-3338-WW(B1801014)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types
    of Childhood Arthritis
    Estudio de evaluación de la seguridad de Etanercept en tres subtipos de artritis en la infancia.
    A.3.2Name or abbreviated title of the trial where available
    Clipper 2
    A.4.1Sponsor's protocol code numberB1801023
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/236/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPFIZER, S.L.U.
    B.1.3.4CountrySpain
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017, USA
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 800 7181021
    B.5.5Fax number+1 303 739 1119
    B.5.6E-mailClinicalTrials.govCallCentrere@pfizer.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 ENBREL 25 mg/ml polvo y disolvente para solución inyectable para uso pediátrico
    D.2.1.1.2Name of the Marketing Authorisation holderWYETH EUROPE LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Powder and solvent for suspension for injection
    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 INNETANERCEPT
    D.3.9.1CAS number 185243690
    D.3.9.2Current sponsor codeB1801023
    D.3.9.3Other descriptive nameETANERCEPT
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.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 ENBREL 50 mg solución inyectable en jeringas precargadas
    D.2.1.1.2Name of the Marketing Authorisation holderWYETH EUROPE LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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
    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 INNETANERCEPT
    D.3.9.1CAS number 185243690
    D.3.9.2Current sponsor codeB1801023
    D.3.9.3Other descriptive nameETANERCEPT
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Oligoarticular juvenile idiopathic arthritis, enthesistis related arthritis, or psoriatic arthritis
    ARTRITIS IDIOPÁTICA JUVENIL OLIGOARTICULAR EXTENDIDA, ARTRITIS ASOCIADA A ENTESITIS O ARTRITIS PSORIÁSICA
    E.1.1.1Medical condition in easily understood language
    3 Sub-types of Childhood Arthritis (Extended Oligoarticular Arthritis,
    Enthesitis-Related Arthritis, and Psoriatic Arthritis)
    3 Subtipos de Artritis en la Infancia (Artritis Oligoarticular Extendida, Artritis asociada a Entesistis y Artritis Psoriásica
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10059176
    E.1.2Term Juvenile idiopathic arthritis
    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 monitor the occurrence of malignancy in pediatric subjects with extended oligoarticular JIA, ERA, or PsA.
    Vigilar la incidencia de neoplasias malignas en niños y adolescentes con AIJ oligoarticular extendida, ARE o APs.
    E.2.2Secondary objectives of the trial
    To assess the long term safety profile of etanercept.
    Evaluar el perfil de seguridad a largo plazo de etanercept.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an
    appropriately qualified member of the investigator's study team before
    subjects are included in the study. Subjects must meet all of the
    following inclusion criteria to be eligible for enrollment into the study:
    1. Evidence of a personally signed and dated informed consent document
    (and assent document, as applicable) indicating that the subject (or a
    legally authorized representative/guardian) has been informed of all
    pertinent aspects of the study.
    2. Subjects who are willing and able to comply with all applicable
    aspects of the study, including scheduled visits, treatment plan,
    laboratory tests, and other study procedures.
    3. Receipt of at least 1 dose of investigational product and participation
    for approximately 96 weeks in study 0881A1 3338.
    4. The subject and the parent or legally authorized
    representative/guardian of the subject must be able to provide contact
    information, including primary care physician or other treating
    physician.
    4.1.1. Additional Inclusion Criteria for Subjects Planning to Continue
    Investigational Product - Subjects must meet the following additional
    inclusion criteria to be eligible to continue investigational product in
    study B1801023:
    5. Have completed approximately 96 weeks of investigational product in
    study 0881A1 3338 and, in the investigator's judgment, is appropriate to
    continue treatment with etanercept.
    6. Either the subject or an available adult must be capable (according to
    the investigator's judgment) of reconstituting and administering
    injections of subcutaneous (SC) etanercept.
    7. The subject, parent, or legally authorized representative/guardian of
    the subject must be able to read and complete the protocol specified
    efficacy assessments.
    8. The first dose of etanercept in study B1801023 must be administered
    within 6 weeks of receiving the last dose of etanercept in the study
    0881A1 3338.
    Those subjects who do not meet entry criteria for continuing
    investigational product after completion of 96 weeks of investigational
    product in study 0881A1 3338 will be asked to participate in the
    observational period in study B1801023.
    Un miembro debidamente cualificado del equipo del estudio del investigador analizará y documentará la elegibilidad de los pacientes antes de su inclusión en el estudio. Los pacientes deberán cumplir todos los criterios de inclusión siguientes para poder participar en el estudio:
    1. Existencia de un documento de consentimiento informado (y un documento de asentimiento, si procede), firmado y fechado personalmente, que indique que se ha informado al paciente (o a su representante legal) de todos los aspectos pertinentes del estudio.
    2. Pacientes dispuestos a cumplir todos los aspectos aplicables del estudio, como las visitas programadas, el plan de tratamiento, las evaluaciones analíticas y otros procedimientos del estudio, y capaces de hacerlo.
    3. Recepción de al menos una dosis del producto en investigación y participación durante aproximadamente 96 semanas en el estudio 0881A1-3338.
    4. El paciente y el progenitor o el representante/tutor legal del paciente deben proporcionar información de contacto, incluido el médico de atención primaria u otro médico encargado de su tratamiento.

    Otros criterios de inclusión para los pacientes en los que esté previsto seguir con el producto en investigación
    Los pacientes deben cumplir los siguientes criterios de inclusión adicionales para poder continuar con el producto en investigación en el estudio B1801023:
    5. Haber completado aproximadamente 96 semanas con el producto en investigación en el estudio 0881A1-3338 y cuando, en opinión del investigador, procede seguir con el tratamiento con etanercept.
    6. El paciente o un adulto disponible deberán ser capaces (según el criterio del investigador) de reconstituir y administrar inyecciones de etanercept por vía subcutánea (SC).
    7. El paciente, los padres o el representante/tutor legal del paciente deberán saber leer y completar las evaluaciones de eficacia especificadas en el protocolo.
    8. La primera dosis de etanercept en el estudio B1801023 debe administrarse en las 6 semanas siguientes a la última dosis de etanercept en el estudio 0881A1-3338.
    Se pedirá a los pacientes que no cumplan los criterios de inclusión para continuar con el producto en investigación después de completar 96 semanas con dicho producto en el estudio 0881A1-3338 que participen en el período de observación en el estudio B1801023.
    E.4Principal exclusion criteria
    Exclusion Criteria for All Subjects - Subjects presenting with any of the
    following will not be included in the study:
    1. Subjects who are investigational site staff members or subjects who
    are Pfizer employees directly involved in the conduct of the trial.
    Additional Exclusion Criteria for Subjects Planning to Continue
    Investigational Product - Subjects who completed approximately 96
    weeks of investigational product in study 0881A1 3338 and present with
    any of the following will not be allowed to continue investigational
    product in study B1801023:
    2. Withdrawal from investigational product in study 0881A1 3338 for any
    reason (safety or non safety).
    3. History of malignancy other than squamous cell, basal cell carcinoma
    or cervical carcinoma in situ.
    4. Participation in other clinical studies of investigational drugs or
    investigational combinations of approved drugs between the week 96
    visit in study 0881A1 3338 and the baseline visit in study B1801023 or
    during participation in the active treatment period of study B1801023.
    5. Pregnant or breastfeeding female subjects.
    6. Receipt of any of the following between the week 96 visit in study
    0881A1 3338 and the baseline visit in study B1801023:
    Any biologic drugs, including but not limited to TNF inhibitors (other
    than etanercept), abatacept, rituximab, anakinra and tocilizumab;
    Immunosuppressive drugs (excluding corticosteroids) (eg,
    cyclophosphamide, cyclosporine, azathioprine);
    Leflunomide;
    Use of more than 1 of the non biologic DMARDs permitted in study
    0881A1-3338 (ie, methotrexate, hydroxychloroquine, chloroquine,
    sulfasalazine) in subject's <18 years of age;
    Use of more than 2 of the non biologic DMARDs permitted in study
    0881A1 3338 (ie, methotrexate, hydroxychloroquine, chloroquine,
    sulfasalazine) or hydroxychloroquine and chloroquine taken at the same
    time in subjects 18 years of age;
    Non biologic DMARDs other than those permitted in study 0881A1
    3338 (ie, methotrexate, hydroxychloroquine, chloroquine, sulfasalazine),
    or those not listed under other exclusion criteria;
    Any live (attenuated) vaccines.
    7. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study
    participation or investigational product administration or may interfere
    with the interpretation of study results and, in the judgment of the
    investigator, would make the subject inappropriate for entry into this
    study.
    8. Signs and symptoms or suspicion of active tuberculosis.
    Criterios de exclusión para todos los pacientes
    No podrán participar en el estudio los pacientes que se encuentren en cualquiera de las circunstancias siguientes:
    1. Sujetos que sean miembros del personal del centro de investigación o empleados de Pfizer directamente implicados en la realización del ensayo.

    Otros criterios de exclusión para los pacientes en los que esté previsto seguir con el producto en investigación
    Los pacientes que completen aproximadamente 96 semanas de tratamiento con el producto en investigación en el estudio 0881A1-3338 y que presenten cualquiera de las circunstancias siguientes no podrán continuar recibiendo dicho producto en el estudio B1801023:
    2. Suspensión del producto en investigación en el estudio 0881A1-3338 por cualquier motivo (seguridad o no seguridad).
    3. Antecedentes de neoplasia maligna distinta del carcinoma espinocelular, carcinoma basocelular o carcinoma del cuello uterino in situ.
    4. Participación en otros estudios clínicos de fármacos en investigación o combinaciones en investigación de fármacos aprobados entre la visita de la semana 96 del estudio 0881A1-3338 y la visita basal en el estudio B1801023 o durante la participación en el período de tratamiento activo del estudio B1801023.
    5. Mujeres embarazadas o lactantes.
    6. Tratamiento con cualquiera de lo siguiente entre la visita de la semana 96 del estudio 0881A1-3338 y la visita basal del estudio B1801023:
    ? Cualquier fármaco biológico, entre otros los inhibidores del TNF (excepto etanercept), abatacept, rituximab, anakinra y tocilizumab;
    ? Inmunodepresores (excepto corticosteroides) (por ejemplo, ciclofosfamida, ciclosporina o azatioprina);
    ? Leflunomida;
    ? Uso de más de uno de los FARME no biológicos permitidos en el estudio 0881A1-3338 (es decir, metotrexato, hidroxicloroquina, cloroquina o sulfasalazina) en pacientes < 18 años;
    ? Uso de más de dos de los FARME no biológicos permitidos en el estudio 0881A1-3338 (es decir, metotrexato, hidroxicloroquina, cloroquina o sulfasalazina) o hidroxicloroquina y cloroquina administradas al mismo tiempo en pacientes ? 18 años;
    ? FARME no biológicos distintos de los permitidos en el estudio 0881A1-3338 (es decir, metotrexato, hidroxicloroquina, cloroquina o sulfasalazina) o que no se mencionen en otros criterios de exclusión;
    ? Cualquier vacuna de microbios vivos (atenuados).
    7. Cualquier otro trastorno médico o psiquiátrico grave, agudo o crónico, o cualquier anomalía analítica que aumente el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o interfiera en la interpretación de los resultados del estudio y, en opinión del investigador, impida la participación en el mismo.
    8. Signos y síntomas o sospecha de tuberculosis activa.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of malignancy.
    Aparición de una neoplasia maligna.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at minimum every 2 years
    como mínimo cada 2 años
    E.5.2Secondary end point(s)
    Key Secondary Endpoints for All Subjects
    -Occurrence of serious adverse events;
    -Occurrence of medically important infections (ie, an infection requiring
    hospitalization and /or parenteral [intravenous (IV), intra-muscular
    (IM)] anti infective agents).
    Additional Key Secondary Endpoints for Subjects in the Active Treatment
    Period
    -Occurrence of all adverse events, including infections, infections
    considered preventable by vaccination, and injection site reactions;
    -Occurrence of withdrawals from investigational product due to adverse
    events;
    -Laboratory evaluations;
    -Growth parameters;
    -Tanner Stage Assessment for selected subjects.
    - Other Secondary Endpoints for Subjects in the Active Treatment Period
    -Physician's Global Assessment (PGA) of Disease Activity on a 21 circle
    visual analogue scale (VAS);
    -Patient/Parent Global Assessment on a 21 circle VAS;
    -C reactive protein (CRP).
    Criterios de valoración secundarios fundamentales para todos los pacientes
    ? Incidencia de acontecimientos adversos graves;
    ? Incidencia de las infecciones médicamente importantes (es decir, una infección que requiera hospitalización o antiinfecciosos por vía parenteral [intravenosos (IV) o intramusculares (IM)]).

    Otros criterios de valoración secundarios fundamentales para los pacientes en el período de tratamiento activo
    ? Incidencia de todos los acontecimientos adversos, incluidas las infecciones consideradas evitables con vacunas, y las reacciones en el lugar de inyección;
    ? Incidencia de suspensiones del producto en investigación por acontecimientos adversos;
    ? Estudios analíticos;
    ? Parámetros del crecimiento;
    ? Evaluación del estadio de Tanner en determinados pacientes.

    Otros criterios de valoración secundarios para los pacientes en el periodo de tratamiento activo
    ? Evaluación global por el médico (PGA) de la actividad de la enfermedad en una escala analógica visual de 21 círculos (EAV);
    ? Evaluación global por el paciente/progenitor en una EAV de 21 círculos;
    ? Proteína C-reactiva (CRP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    at minimum every 2 years
    como mínimo cada 2 años
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.3 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 EEA28
    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
    Australia
    Belgium
    Colombia
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Latvia
    Lithuania
    Mexico
    Netherlands
    Norway
    Poland
    Russian Federation
    Serbia
    Slovakia
    Slovenia
    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
    As per protocol
    Según protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days12
    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: 99
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 32
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 67
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 24
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subject, parent, or legally authorized representative/guardian of the
    subject must be able to read and complete the protocol specified efficacy assessments.
    Sujeto, padre o representante legal / tutor del sujeto deben ser capaces de comprender y completar las evaluaciones de eficacia específicas del protocolo.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 109
    F.4.2.2In the whole clinical trial 123
    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)
    After subjects particpation in the trial, he/she will receive the normal standard of care for their disease.
    Después de la participación de sujetos en el estudio, el/ella recibirá el cuidado normal de su enfermedad
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation No aplica
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-04
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