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    Summary
    EudraCT Number:2015-004112-38
    Sponsor's Protocol Code Number:C25004
    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:2016-11-17
    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 number2015-004112-38
    A.3Full title of the trial
    An Open-Label Study of Brentuximab Vedotin+Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
    Estudio abierto con Brentuximab Vedotin+ Adriamicina, Vinblastina y Dacarbazina en pacientes pediátricos con linfoma de Hodgkin en estadio avanzado recientemente diagnosticado .
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brentuximab vedotin+Adriamycin, vinblastine, and dacarbazine in pediatric patients with advanced stage newly diagnosed Hodgkin lymphoma
    Brentuximab Vedotin+Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma
    A.4.1Sponsor's protocol code numberC25004
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/263/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMillennium Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    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 supportMillenium Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals Inc.
    B.5.2Functional name of contact pointResponsible Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34654461488
    B.5.6E-mailGlobalOncologyMedinfo@takeda.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 ADCETRIS®
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/596
    D.3 Description of the IMP
    D.3.1Product nameADCETRIS®
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    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 INNBRENTUXIMAB VEDOTIN
    D.3.9.1CAS number 914088-09-8
    D.3.9.2Current sponsor codeSGN-35
    D.3.9.3Other descriptive nameBRENTUXIMAB VEDOTIN
    D.3.9.4EV Substance CodeSUB32397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Hodgkin lymphoma (HL), a neoplasm of lymphoid tissue which is histopathologically defined by the presence of malignant Hodgkin Reed-Sternberg (HRS) cells in a background of inflammatory cells.
    The proposed pediatric study has been designed to evaluate brentuximab vedotin as a component of a multiagent frontline chemotherapy regimen in patients with advanced stage, newly diagnosed HL, here defined as Stage III and Stage IV and a ≥50 Lansky Play-Performance or Karnofsky Performance Status.
    Hodgkin (HL), una neoplasia de tejido linfoide que se define histopatológicamente por la presencia de células malignas de Hodgkin Reed-Sternberg (HRS) en un fondo de células inflamatorias..Pacientes varones o mujeres de 5 a < 18 años de edad con un LH CD30+ clásico avanzado (estadio III o IV según Ann Arbor) recientemente diagnosticado que no reciben tratamiento, con un estado general según la escala Karnofsky o de ejecución de juegos de Lansky > 50
    E.1.1.1Medical condition in easily understood language
    Hodgkin lymphoma (HL)
    Linfoma de Hodgkin
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLGT
    E.1.2Classification code 10025319
    E.1.2Term Lymphomas Hodgkin's disease
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1 Primary Objective:
     To assess the safety and tolerability, and to identify the recommended dose of brentuximab vedotin when combined with multiagent chemotherapy regimen AVD for first-line treatment of advanced stage HL in pediatric patients.

    Phase 2 Primary Objectives:
     To evaluate the CR rate of pediatric patients with advanced stage HL at the end of protocol therapy.
     To determine the percentage of patients who are PET- after 2 cycles of protocol therapy.
     To evaluate the PR rate of pediatric patients with advanced stage HL at the end of protocol therapy.
     To evaluate the ORR of pediatric patients with advanced stage HL at the end of protocol therapy.
     To determine the percentage of patients who are able to complete 6 cycles of protocol therapy at the
    recommended dose.
    Objetivo principal de la fase I:
    Evaluar la seguridad y la tolerabilidad e identificar la dosis recomendada de brentuximab vedotina cuando se combina con la pauta de quimioterapia con varios fármacos AVD como tratamiento de primera línea del LH en estadio avanzado en pacientes pediátricos.
    Objetivos principales de la fase II:
    • Evaluar la tasa de RC de pacientes pediátricos con LH de estadio avanzado al final del tratamiento del protocolo.
    • Determinar el porcentaje de pacientes que son TEP- después de haber recibido 2 ciclos de tratamiento del protocolo.
    • Evaluar la tasa de RP de pacientes pediátricos con LH de estadio avanzado al final del tratamiento del protocolo.
    • Evaluar la tasa de TRG de pacientes pediátricos con LH de estadio avanzado al final del tratamiento del protocolo.
    • Determinar el porcentaje de pacientes que son capaces de completar 6 ciclos del tratamiento del protocolo a la dosis recomendada.
    E.2.2Secondary objectives of the trial
    Phase 1 Secondary Objectives:
     To describe the maximum observed concentration (Cmax), area under the concentration-time curve from time 0 to 15 days (AUC0-15), and time of first time of occurrence of Cmax (Tmax) of brentuximab vedotin, monomethyl auristatin E (MMAE), and total (free and conjugated) therapeutic antibody (TAb).

    For further - please refer to Protocol

    Phase 2 Secondary Objectives:
     To evaluate the progression-free survival (PFS), event-free survival (EFS), overall survival (OS), and duration of response (DOR) in pediatric patients with advanced stage HL treated with protocol therapy.

    For further - please refer to Protocol
    Objetivos secundarios de la fase I:
    • Describir la concentración máxima observada (Cmáx.), el área bajo la curva de concentración-tiempo desde el momento 0 hasta el día 15 (ABC0-15) y el momento de la primera aparición de Cmáx. (Tmáx.) de anticuerpos frente a brentuximab vedotina, monometil auristatina E (MMAE) y anticuerpos terapéuticos (AcT) totales (libres y conjugados).
    Para más informacion-consulte protocolo.

    Objetivos secundarios de la fase II:
    • Evaluar la supervivencia sin progresión (SLP), la supervivencia libre de acontecimientos (SLA), la supervivencia general (SG) y la duración de la respuesta (DdR) en pacientes pediátricos con LH en estadio avanzado con tratamiento del protocolo.
    Para más informacion-consulte protocolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Criteria for Inclusion:
    Male or female patients aged 5 to <18 years with newly diagnosed classical CD30+ advanced stage (Stage III and Stage IV) HL who are treatment naïve with Karnofsky Performance Status or Lansky Play-Performance ≥50.
    Criterios de inclusión principales:
    Pacientes varones o mujeres de 5 a < 18 años de edad con un LH CD30+ clásico avanzado (estadio III y IV) recientemente diagnosticado que no reciben tratamiento, con un estado general según la escala Karnofsky o de ejecución de juegos de Lansky ≥ 50.
    E.4Principal exclusion criteria
    Main Criteria for Exclusion:
    Patients may not have nodular lymphocyte-predominant HL, known active cerebral meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML, sensory or motor peripheral neuropathy, or known hypersensitivity to brentuximab vedotin or any component of AVD.
    Criterios de exclusión principales:
    Los pacientes no pueden presentar un LH nodular de predominio linfocítico, una enfermedad cerebral activa conocida, con signos o síntomas de leucoencefalopatía multifocal progresiva (LMP) o antecedentes de LMP, neuropatía sensorial o motora periférica o hipersensibilidad conocida a brentuximab vedotina o a cualquier componente de AVD.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1 Primary Endpoints
     Determination of the recommended dose of brentuximab vedotin in combination with AVD in a pediatric population.
     Percentage of patients who experience AEs from the first dose of protocol therapy through 30 days after administration of the last dose of protocol therapy.
     Percentage of patients who experience serious AEs (SAEs) from the first dose of protocol therapy through 30 days after administration of the last dose of protocol therapy.

    Phase 2 Primary Endpoints
     Percentage of patients who achieve a CR per IRF assessment at EOT per IWG criteria.
     Percentage of patients whose disease is PET- after 2 cycles of protocol therapy per IRF assessment.
     Percentage of patients who achieve a PR per IRF assessment at EOT per IWG criteria.
     Percentage of patients who achieve an OR per IRF assessment at EOT per IWG criteria.
     Percentage of patients who are able to complete 6 cycles of protocol therapy at the recommended dose.
    Los criterios de valoración principales de la fase I de este estudio son:
    • Determinación de la dosis recomendada de brentuximab vedotina en combinación con AVD en la población pediátrica.
    • Porcentaje de pacientes con acontecimientos adversos (AA) desde la primera dosis del tratamiento del protocolo hasta 30 días después de la administración de la última dosis del tratamiento del protocolo.
    • Porcentaje de pacientes con acontecimientos adversos graves (AAG) desde la primera dosis del tratamiento del protocolo hasta 30 días después de la administración de la última dosis del tratamiento del protocolo.
    Los criterios de valoración principales de la fase II de este estudio son:
    • Porcentaje de pacientes que logran una RC según la evaluación efectuada al FDT por el CRI en función de los criterios IWG [1].
    • Porcentaje de pacientes con enfermedad TEP- después de haber recibido 2 ciclos de tratamiento del protocolo, según la evaluación efectuada por el CRI.
    • Porcentaje de pacientes que logran una RP según la evaluación efectuada al FDT por el CRI en función de los criterios IWG [1].
    • Porcentaje de pacientes que logran una RG según la evaluación efectuada al FDT por el CRI en función de los criterios IWG [1].
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please see above
    por favor, mirar arriba
    E.5.2Secondary end point(s)
    Phase 1 Secondary Endpoints
     Mean Cmax and mean AUC0-15 of brentuximab vedotin (serum), TAb (serum), and MMAE (plasma).
     Median Tmax of brentuximab vedotin (serum), TAb (serum), and MMAE (plasma).
     Percentage of patients who achieve a CR per independent review facility (IRF) assessment at End of Treatment (EOT) per International Working Group (IWG) criteria.
     Percentage of patients who achieve a PR per IRF assessment at EOT per IWG criteria.
     Percentage of patients who achieve an overall response (OR) per IRF assessment at EOT per IWG criteria.
     Percentage of patients whose disease is PET- after 2 cycles of protocol therapy per IRF assessment.
     Percentage of patients whose disease is PET+ after 6 cycles of protocol therapy per IRF assessment.
     Percentage of patients who are ATA positive, persistently positive, or transiently positive, ATA titer and neutralizing ATA (nATA) positive at baseline, predose Cycle 2 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, or at termination if treatment is terminated before Cycle 6, and at EOT.
     Impact of ATA and nATA on the safety, efficacy, and PK endpoints.

    Phase 2 Secondary Endpoints
     PFS, EFS, OS, DOR.
     Percentage of patients receiving irradiation for HL following study treatment.
     Percentage of patients who experience AEs from the first dose of protocol therapy through 30 days after administration of the last dose of protocol therapy.
     Percentage of patients who experience SAEs from the first dose of protocol therapy through 30 days after administration of the last dose of protocol therapy.
     Percentage of patients who are ATA positive, persistently positive, or transiently positive, ATA titer and nATA positive at baseline, predose Cycle 2 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, or at termination if treatment is terminated before Cycle 6, and at EOT.
     Impact of ATA and nATA on the safety, efficacy, and PK endpoints.
     Mean Cmax and mean AUC0-15 of brentuximab vedotin (serum), TAb (serum), and MMAE (plasma).
     Median Tmax of brentuximab vedotin (serum), TAb (serum), and MMAE (plasma).
     Percentage of patients who experience peripheral neuropathy, regardless of seriousness, from the first dose of protocol therapy through study closure.
     Time to onset and time to resolution for all peripheral neuropathy events.
     Immune reconstitution (peripheral blood CD34+ count; enumeration of the total lymphocyte count and lymphocyte subsets; total Ig and IgG, IgM, and IgA levels; and levels of the antibodies to tetanus, HiB, and polio serotypes) at baseline, EOT, and at 6, 12, and 18 months (±1 month) after last dose, until the start of subsequent anticancer therapy (with the exception of radiotherapy administered as part of first-line therapy).
    Los criterios de valoración secundarios de la fase I de este estudio son:
    • Valor medio de Cmáx. y valor medio de ABC0-15 de brentuximab vedotina (suero), AcT (suero) y MMAE (plasma).
    • Valor mediana de Tmáx. de brentuximab vedotina (suero), AcT (suero) y MMAE (plasma).
    • Porcentaje de pacientes que logran una RC según la evaluación efectuada al FDT por el CRI en función de los criterios IWG [1],
    • Porcentaje de pacientes que logran una RP según la evaluación efectuada al FDT por el CRI en función de los criterios IWG [1],
    • Porcentaje de pacientes que logran una RG según la evaluación efectuada al FDT por el CRI en función de los criterios IWG [1],
    • Porcentaje de pacientes con enfermedad TEP- después de haber recibido 2 ciclos de tratamiento del protocolo, según la evaluación efectuada por el CRI.
    • Porcentaje de pacientes con enfermedad TEP+ después de haber recibido 6 ciclos de tratamiento del protocolo, según la evaluación efectuada por el CRI.
    • Porcentaje de pacientes con AAT positivos, positivos de forma persistente o transitoria, título de AAT y AAT neutralizantes (AATn) positivos al inicio, antes de la dosis del día 1 del ciclo 2, día 1 del ciclo 4, día 1 del ciclo 6 o a la finalización si el tratamiento finaliza antes del ciclo 6, y al FDT.
    • Influencia de los AAT y los AATn sobre los criterios de valoración principales de seguridad, los criterios secundarios de eficacia y la FC.
    Los criterios de valoración secundarios de la fase II de este estudio son:
    • SLP, SLA, SG, DdR.
    • Porcentaje de pacientes que después del tratamiento del estudio reciben radioterapia para el LH.
    • Porcentaje de pacientes con AAG desde la primera dosis del tratamiento del protocolo hasta 30 días después de la administración de la última dosis del tratamiento del protocolo.
    • Porcentaje de pacientes con AAG desde la primera dosis del tratamiento del protocolo hasta 30 días después de la administración de la última dosis del tratamiento del protocolo.
    • Porcentaje de pacientes con AAT positivos, positivos de forma persistente o transitoria, título de AAT y AATn positivos al inicio, antes de la dosis del día 1 del ciclo 2, día 1 del ciclo 4, día 1 del ciclo 6 o a la finalización si el tratamiento finaliza antes del ciclo 6, y al FDT.
    • Influencia de los AAT y los AATn sobre los criterios de valoración principales de seguridad, los criterios secundarios de eficacia y la FC.
    • Valor medio de Cmáx. y valor medio de ABC0-15 de brentuximab vedotina (suero), AcT (suero) y MMAE (plasma).
    • Valor mediana de Tmáx. de brentuximab vedotina (suero), AcT (suero) y MMAE (plasma).
    • Porcentajes de pacientes con neuropatía periférica, con independencia de la intensidad, desde la primera dosis del tratamiento del protocolo hasta la clausura del estudio.
    • Periodo de tiempo hasta el inicio y hasta la resolución de todos los eventos de neuropatía periférica.
    • Reconstitución inmunológica (recuento CD34+ en sangre periférica; enumeración del recuento total de linfocitos y subgrupos de linfocitos; inmunoglobulina [Ig] total y concentraciones de IgG, IgM e IgA; y concentraciones de anticuerpos frente al tétanos, haemophilus influenza tipo B [HiB] y serotipos de polio) al inicio, al FDT, y en los meses 6, 12 y 18 (± 1 mes) después de la última dosis, hasta el inicio del tratamiento antineoplásico siguiente (con la excepción de radioterapia administrada como parte del tratamiento de primera línea).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see above
    por favor, mirar arriba
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    To determine the recommended dose
    determinar la dosis recomendada
    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 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.8.3 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 EEA15
    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
    Bulgaria
    Canada
    Italy
    Spain
    United States
    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
    The primary analyses for the clinical study report will be conducted a minimum of 8 weeks after the last patient enrolled receives the last dose of protocol therapy. The updated analyses on the efficacy endpoints will be conducted after all patients enrolled in the study have had the opportunity to be followed for 2 years from the time of enrollment, and will be included in an addendum to the clinical study report.
    Los análisis para el informe del estudio clínico se llevarán a cabo un mínimo de 8 semanas después de que el último paciente registrado reciba la última dosis de la terapia de protocolo. Los análisis actualizados sobre los criterios de valoración de la eficacia se llevarán a cabo después de que todos los pacientes incluidos en el estudio hayan tenido la oportunidad de ser seguidos durante 2 años a partir del momento de la inscripción, y se incluirán en una adición al informe del estudio clínico.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 61
    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: 12
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 49
    F.1.2Adults (18-64 years) No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 61
    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 Decision2017-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-11
    P. End of Trial
    P.End of Trial StatusOngoing
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