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    Summary
    EudraCT Number:2017-001829-40
    Sponsor's Protocol Code Number:201
    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:2017-12-21
    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 number2017-001829-40
    A.3Full title of the trial
    A Phase 3 Trial of Antibody hu3F8 and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients with Primary or Secondary Refractory Osteomedullary Disease
    Ensayo de Fase 3 del anticuerpo hu3F8 y factor estimulante de colonias de granulocitos y macrófagos (GM-CSF) en pacientes con Neuroblastoma de alto riesgo con enfermedad ostemedular refractaria primaria o secundaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in which High-Risk Neuroblastoma Patients with Primary or Secondary Refractory Osteomedullary Disease are treated with Antibody hu3F8 (study drug) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF). The tolerability and efficacy of the drug will be tested.
    Estudio clínico en lo que los pacientes con Neuroblastoma de alto riesgo con enfermedad osteomedular refractaria primaria o secundaria son tratados con el anticuerpo hu3F8 (medicamento en investigación) y el factor estimulante de colonias de granulocitos y macrófagos (GM-CSF). Se evaluará la tolerabilidad y la eficacia del medicamento.
    A.4.1Sponsor's protocol code number201
    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 SponsorY-mAbs Therapeutics A/S
    B.1.3.4CountryDenmark
    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 supportY-mAbs Therapeutics A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSermes Planificacion SL
    B.5.2Functional name of contact pointUnidad de Puesta en Marcha
    B.5.3 Address:
    B.5.3.1Street AddressC/Rufino González 14, Esc.1ª-2ºD
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913275025
    B.5.5Fax number+34917542721
    B.5.6E-mailstart-up@sermescro.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 nameHu3F8 drug product
    D.3.2Product code Hu3F8
    D.3.4Pharmaceutical form 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 INNnaxitamab
    D.3.9.1CAS number 1879925-92-4
    D.3.9.2Current sponsor codeHu3F8 drug substance
    D.3.9.3Other descriptive nameHu3F8
    D.3.9.4EV Substance CodeSUB188982
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.8 to 2.2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy 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 Leukine
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis U.S. LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLeukine
    D.3.4Pharmaceutical form Lyophilisate for 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 INNSARGRAMOSTIM
    D.3.9.1CAS number 123774-72-1
    D.3.9.3Other descriptive nameGM-CSF
    D.3.9.4EV Substance CodeSUB10450MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Treatment of primary or secondary refractory neuroblastoma
    Tratamiento de neuroblastoma refractario primario o secundario
    E.1.1.1Medical condition in easily understood language
    Treatment of primary or secondary refractory neuroblastoma
    Tratamiento de neuroblastoma refractario primario o secundario
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10066595
    E.1.2Term Neuroblastoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of intravenous hu3F8 + GM-CSF
    Evaluar la eficacia de la administración intravenosa de hu3F8 + GM-CSF
    E.2.2Secondary objectives of the trial
    1- To evaluate the safety of intravenous hu3F8 + GM-CSF
    2- To evaluate duration of response (DoR) from the start of hu3F8 + GM-CSF
    3- To evaluate progression free survival (PFS) of hu3F8 + GM-CSF
    4- To evaluate overall survival (OS) at 2 years following hu3F8 + GM-CSF
    5- To evaluate the pharmacokinetics (PK) of hu3F8 and investigate the formation of human anti-human antibodies (HAHAs)
    1- Evaluar la seguridad de la administración intravenosa de hu3F8 + GMCSF
    2- Evaluar la duración de la respuesta (DoR) desde el inicio del tratamiento hu3F8 + GM-CSF
    3- Evaluar la supervivencia libre de progresión (SLP) del tratamiento hu3F8 + GM-CSF
    4- Evaluar la supervivencia global (SG) a 2 años tras el tratamiento hu3F8 + GM-CSF
    5- Evaluar la farmacocinética (PK) de hu3F8 e investigar la formación de anticuerpos anti-humanos humanos (HAHAs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 - Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria as
    a) histopathology of tumor biopsy, or
    b) bone marrow aspirate or biopsy indicative of neuroblastoma or
    c) MIBG-avid lesion(s) plus high blood or urine catecholamine metabolite levels. Patients with MIBG-non-avid tumor lesions must be positive on FDG-PET
    2 - High-risk neuroblastoma with either primary refractory or secondary refractory osteomedullary disease (persistent NB at osteomedullary sites after prior treatment)
    3 - Life expectancy ≥ 6 months
    4 - Patients must be older than 1 year of age
    5 - Acceptable hematological status, (hematological support is allowed if administered at least 2 weeks before first administration of hu3F8), defined as:
    a. Hemoglobin ≥ 9 g/dL (5.6 mmol/L)
    b. While blood cell count ≥1000/µL
    c. Absolute neutrophil count ≥500/µL
    d. Platelet count ≥25,000/µL
    6 -Acceptable liver function defined as:
    a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 times upper limit of normal (ULN)
    b. Bilirubin ≤ 1.5 x ULN
    7 - Acceptable kidney function defined as:
    a. eGFR >60 mL/min/1.73 m2 calculated by the 2009 revised Bedside Schwartz Equation
    8 - Written informed consent from legal guardian(s) and/or child in accordance with local regulations. Children must provide assent as required by local regulations
    1 - Diagnóstico de neuroblastoma según se define en los Criterios Internacionales de Respuesta del Neuroblastoma:
    a) histopatología de biopsia tumoral, o
    b) aspirado o biopsia de médula ósea indicativa de neuroblastoma o
    c) lesión(es) ávida(s) de MIBG con altos niveles de metabolitos de catecolaminas en sangre u orina. Los pacientes con lesiones tumorales MIBG no-ávidas, deben ser positivos en FDG-PET
    2 - Neuroblastoma de alto riesgo con enfermedad osteomedular refractaria primaria o secundaria (NB persistente en zonas osteomedulares tras tratamiento previo)
    3 - Esperanza de vida ≥ 6 meses
    4 - Los pacientes deben ser mayores de 1 año de edad
    5 - Estado hematológico aceptable, (se admite soporte hematológico si se administra al menos 2 semanas antes de la primera administración de hu3F8), definido como:
    a. Hemoglobina ≥ 9 g/dL (5,6 mmol/l)
    b. Recuento de glóbulos blancos ≥1000/μL
    c. Recuento absoluto de neutrófilos ≥500/μL
    d. Recuento de plaquetas ≥25.000/μL
    6 - Función hepática aceptable definida como:
    a. Alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) ≤ 5 veces el límite superior de normalidad (LSN)
    b. Bilirrubina ≤1,5xLSN
    7 - Función renal aceptable definida como:
    a. eGFR>60 mL/min/1,73 m2 calculado por la Ecuación de Bedside Schwartz revisada de 2009
    8 - Consentimiento informado por escrito por el(los) tutor(es) legal(es) y/o el niño de acuerdo con las normativas locales. Los niños deben dar su consentimiento según lo exigido por las normativas locales
    E.4Principal exclusion criteria
    1. Chemotherapy or immunotherapy within 3 weeks prior to start of hu3F8
    2. Evidence of neuroblastoma outside osteomedullary sites (any neuroblastoma outside osteomedullary sites must have been removed prior to trial entry)
    3. Existing major organ dysfunction > Grade 2, with the exception of hearing loss and hematologic status,kidney and liver function
    4. Active life-threatening infection
    5. Pregnancy or a woman who is breast-feeding (women of child-bearing potential must have a negative pregnancy test at screening). A woman of child-bearing potential is excluded if she does not agree to use adequate contraception for a period of 40 days after the last hu3F8 dose: intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections). In certain cases, it is accepted to use double barrier methods (a condom combined with a diaphragm). A sterilized or infertile woman is exempt from the requirement to use contraception after hu3F8 treatment: she must have undergone surgical sterilization (hysterectomy, or bilateral ovariectomy).
    6. Inability to comply with protocol requirements, including PK studies, as determined by the investigator
    7. History of allergy or known hypersensitivity to GM-CSF, yeast-derived products, or any component of the product
    1. Quimioterapia o inmunoterapia en las 3 semanas previas al inicio del tratamiento con hu3F8
    2. Evidencia de neuroblastoma fuera de zonas osteomedulares (cualquier neuroblastoma fuera de las zonas osteomedulares debe haber sido eliminado antes del entrar en el ensayo)
    3. Presencia de disfunción en un órgano principal > Grado 2, con excepción de la pérdida de audición, estado hematológico, y función renal y hepática
    4. Infección activa potencialmente mortal.
    5. Embarazo o mujer que está lactando (las mujeres en edad fértil deben tener una prueba de embarazo negativa durante la selección). Se excluyen las mujeres en edad fértil que no consiente en usar un método anticonceptivo adecuado hasta 40 días después de la última dosis de hu3F8: dispositivos intrauterinos o anticonceptivos hormonales (píldoras anticonceptivas orales, implantes, parches transdérmicos, anillos vaginales o inyecciones de acción prolongada). En ciertos casos, se acepta el uso de métodos de doble barrera (un condón combinado con un diafragma). Una mujer esterilizada o infértil está exenta del uso un método anticonceptivo tras el tratamiento con hu3F8: debe haber sido sometidas a esterilización quirúrgica (histerectomía o la ovariectomía bilateral).
    6. Incapacidad para cumplir con los requisitos del protocolo, incluidos los estudios de PK, según lo determinado por el investigador.
    7. Historia clínica de alergia o hipersensibilidad conocida a GM-CSF, productos derivados de levadura, o cualquier componente del medicamento
    E.5 End points
    E.5.1Primary end point(s)
    Overall objective response rate (ORR) during the hu3F8 treatment period that will be centrally assessed according to the International Neuroblastoma Response Criteria (INRC) modified with 123I-MIBG criteria and following the use of 18F FDG-PET for MIBG non-avid lesions
    Tasa de respuesta global (TRG) durante el tratamiento con hu3F8 que se evaluará de forma centralizada según los Criterios Internacionales de Respuesta del Neuroblastoma (INRC) modificados con los criterios 123I-MIBG y seguido del uso de 18F FDG-PET para lesiones no-ávidas a MIBG
    E.5.1.1Timepoint(s) of evaluation of this end point
    During and up to 101 weeks following the first hu3F8 treatment
    Durante y hasta 101 semanas después del primer tratamiento con hu3F8
    E.5.2Secondary end point(s)
    1 - Safety will be evaluated by the incidence of adverse events (AE) and serious adverse events (SAEs) graded according to CTCAE, version 4.0.
    2 - DoR, defined as the length of time from patient response to disease progression as assessed by periodic scans (CT/MRI and 123I-MIBG) and bone marrow histology for up to 24 months from the start of hu3F8 + GM-CSF, using the INRC response criteria.
    3 - PFS, defined as the interval from the date of first dose of hu3F8 until the date of disease progression as determined by objective histological or radiographic disease assessments, or death due to any cause if occurring sooner than progression.
    4 - OS, defined as the interval from the date of first dose of hu3F8 until the date of death due to any cause.
    5 - Assessment of the pharmacokinetic profile of hu3F8.
    6 - Assessment of HAHA formation.
    7 - Intravenous opioid use during cycle 1 defined as total usage of i.v. morphine (or equivalent opioid) administered 2 hours prior to infusion until 4 hours after end of infusion.
    8 - Number of hospitalization days related to hu3F8 infusion during cycle 1, defined as number of overnight stays. Hospitalizations required solely for protocol-specified assessments (e.g. PK sampling) are excluded
    1 - La seguridad será evaluada por la incidencia de acontecimientos adversos (AA) y acontecimiento adverso grave (AAG) clasificados según los CTCAE, versión 4.0.
    2 - DoR, definida como el intervalo de tiempo desde respuesta del paciente hasta progresión de la enfermedad según determinación mediante las evaluaciones periódicas mediante escáner (TC/IRM y 123I-MIBG) y la histología de médula ósea hasta los 24 meses desde el inicio del tratamiento con hu3F8 + GM-CSF, empleando los criterios de respuesta de INRC.
    3 - SLP, definida como el intervalo de tiempo desde la fecha de la primera dosis de hu3F8 hasta la fecha de la progresión de la enfermedad determinada por evaluaciones objetivas de la enfermedad histológicas o radiográficas , o hasta la fecha de la muerte por cualquier causa si ocurriera antes de la evolución.
    4 - SG, definida como el intervalo de tiempo desde la fecha de la primera dosis de hu3F8 hasta la fecha de muerte por cualquier causa.
    5 - Evaluación del perfil farmacocinético de hu3F8.
    6 - Evaluación de la formación de HAHA
    7 - Uso intravenoso de opiáceos durante el ciclo 1 definido como uso total de morfina intravenosa (u opiáceo equivalente) administrada 2 horas antes de la infusión hasta 4 horas después del final de la infusión.
    8 - Número de días de hospitalización relacionado con la infusión de hu3F8 durante el ciclo 1, definido como noches de ingreso. Se excluyen las hospitalizaciones debidas únicamente a evaluaciones especificas del protocolo (por ejemplo, obtención de muestras de PK)
    E.5.2.1Timepoint(s) of evaluation of this end point
    During and up to 101 weeks following the first hu3F8 treatment
    Durante y hasta 101 semanas después del primer tratamiento con hu3F8
    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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Denmark
    Spain
    United Kingdom
    United States
    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 trial is defined as last patient last visit in the long term follow-up
    La Fin del Ensayo se define como la última visita del ultimo paciente en el seguimiento a largo plazo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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: 37
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 17
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 18
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients could be be between the ages of 1 year and 18 years and therefore informed consent from legal guardian(s) and/or child must be obtained in accordance with local regulations. Children must provide assent as required by local regulations
    Para los pacientes entre 1 y 18 años es requerido el consentimiento informado por el(los) tutor(es) legal(es) y/o el niño de acuerdo con las normativas locales. Los niños deben aportar su consentimiento según lo exigido por las normativas locales
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 37
    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)
    Any treatment which is deemed safe and justified can be administered according to clinical practice and at the discretion of the investigator
    Cualquier tratamiento que se considere seguro y justificado puede administrarse de acuerdo con la práctica clínica y a discreción del investigador
    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 Decision2018-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-28
    P. End of Trial
    P.End of Trial StatusOngoing
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