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    Summary
    EudraCT Number:2019-004511-31
    Sponsor's Protocol Code Number:cASPerCF_2007_OPBG_2019
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-08-30
    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 number2019-004511-31
    A.3Full title of the trial
    Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.
    Validación prospectiva y evaluación clínica de un nuevo régimen de dosificación de posaconazol para niños y adolescentes con fibrosis quística e infección por Aspergillus.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.
    Validación prospectiva y evaluación clínica de un nuevo régimen de dosificación de posaconazol para niños y adolescentes con fibrosis quística e infección por Aspergillus.
    A.3.2Name or abbreviated title of the trial where available
    cASPerCF
    cASPerCF
    A.4.1Sponsor's protocol code numbercASPerCF_2007_OPBG_2019
    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 SponsorBambino Gesù Children´s Hospital
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInnovative Medicines Initiative 2
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportEuropean Union´s Horizon 2020
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBambino Gesù Children's Hospital
    B.5.2Functional name of contact pointA.R. INFETTIVOLOGIA E SVILUPPO DI F
    B.5.3 Address:
    B.5.3.1Street Addresspiazza S.Onofrio, 4
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00165
    B.5.3.4CountryItaly
    B.5.6E-mailbetty.polikar@opbg.net
    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 NOXAFIL - oral suspension 40 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP e DOHME LIMITED
    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.3.1Product nameNoxafil
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Noxafil 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme 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.3.1Product nameNoxafil
    D.3.4Pharmaceutical form Gastro-resistant tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cystic Fibrosis and Aspergillus infection
    Fibrosis quística e infección por Aspergillus
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis and Aspergillus infection
    Fibrosis quística e infección por Aspergillus
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003488
    E.1.2Term Aspergillosis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objectives:
    PK
    - To validate a paediatric posaconazole dosing regimen for children and adolescents with CF and Aspergillus infection.
    Clinical efficacy
    - To examine the efficacy of posaconazole versus usual care in children and adolescents with CF and Aspergillus infection in terms of clearance of Aspergillus from the airways after three months.
    Objetivos principales:
    PK
    - Validar una pauta posológica pediátrica de posaconazol para niños y adolescentes con FQ e infección por Aspergillus.
    Eficacia clínica
    - Examinar la eficacia del posaconazol frente a la atención habitual en niños y adolescentes con FQ e infección por Aspergillus en términos de eliminación de Aspergillus de las vías respiratorias después de tres meses.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    PK
    - To define in silico the optimal dose for patients with CF aged 8 - 17 years.
    - To define the detailed pharmacokinetics in a limited number of children and adolescents with CF and Aspergillus infection aged 8-17 yrs through an intensive PK sampling study
    Epidemiology, clinical efficacy and safety
    - To determine the prevalence of Aspergillus infection in children and adolescents aged 8 to 17 years.
    - To assess the safety and tolerability of posaconazole in children and adolescents with CF and Aspergillus infection.
    - To assess the clinical efficacy of posaconazole versus usual care in terms of (1) serological responses to Aspergillus; (2) airway inflammation, and (3) clinical outcomes (as measured by pulmonary exacerbation rate, days on antibiotics and corticosteroids, hospital admissions, quality of life, change in FEV1, change in BMI, CT- chest abnormalities)
    Objetivos secundarios:
    PK
    - Definir in-silico la dosis óptima para pacientes con FQ de 8 a 17 años.
    - Definir la farmacocinética detallada en un número limitado de niños y adolescentes de 8 a 17 años con FQ e infección por Aspergillus a través de un estudio farmacocinético de muestreo intensivo.

    Epidemiología, eficacia clínica y seguridad:
    - Determinar la prevalencia de la infección por Aspergillus en niños y adolescentes de 8 a 17 años.
    - Evaluar la seguridad y tolerabilidad del posaconazol en niños y adolescentes con FQ e infección por Aspergillus.
    - Evaluar la eficacia clínica del posaconazol frente a la atención habitual en términos de (1) respuestas serológicas a Aspergillus; (2) inflamación de las vías respiratorias y (3) resultados clínicos (medidos por la tasa de exacerbación pulmonar, días con antibióticos y corticosteroides, ingresos hospitalarios, calidad de vida, cambio en la FEV1, cambio en el IMC, anomalias en TAC torácico)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for the screening phase:

    1. Diagnosed with cystic fibrosis (genetic diagnosis and/or abnormal sweat test and clinical phenotype of lung disease)
    2. Age ≥ 8 yrs and < 18 yrs
    3. Body weight ≥ 20 kg
    4. Able to produce a sputum sample (spontaneous or induced sputum)
    5. Informed Consent given

    Inclusion criteria for the intervention phase:
    1. Diagnosed with cystic fibrosis (genetic diagnosis and/or abnormal sweat test and clinical phenotype of lung disease)
    2. Age ≥ 8 yrs and < 18 yrs
    3. Body weight ≥20 kg
    4. Presence of Aspergillus infection as defined for this study
    5. Clinically stable condition without a significant change in lung function (FEV1 +/- 10%) or significant worsening of respiratory symptoms over the previous month
    6. Able to perform lung function test (FEV1%)
    7. Able to produce a sputum sample (spontaneous or induced sputum)
    8. Informed Consent given
    9. If female and of childbearing age must be using highly effective contraception (and must agree to continue for 7 days after the last dose of investigational medicinal product [IMP])
    Criterio de inclusión Fase de selección (n=1500):

    1. Diagnóstico de fibrosis quística (diagnóstico genético y/o test de sudor con valores anormales y fenotipo clínico de enfermedad pulmonar)
    2. Edad ≥ 8 años y < 18 años
    3. Peso corporal ≥ 20 kg
    4. Capaz de producir una muestra de esputo (espontánea o inducida)
    5. Firma Consentimiento Informado


    Criterios de inclusión Fase de Intervención

    1. Diagnóstico de fibrosis quística (diagnóstico genético y/o test de sudor con valores anormales y fenotipo clínico de enfermedad pulmonar)
    2. Edad ≥ 8 años y < 18 años
    3. Peso corporal ≥ 20 kg
    4. Presencia de infección por Aspergillus según se define para este estudio.
    5. Situación clínica estable, sin cambios significativos en la función pulmonar (FEV1 +/- 10%) o empeoramiento significativo de los síntomas respiratorios durante el mes previo.
    6. Capaz de realizar un test función pulmonar (FEV1%)
    7. Capaz de producir una muestra de esputo (espontánea o inducida)
    8. Firma de Consentimiento Informado
    9. En caso de mujeres en edad fértil: utilización de un método anticonceptivo altamente eficaz durante su participación en el estudio y hasta 7 días después de la última dosis del medicamento en investigación.
    E.4Principal exclusion criteria
    Exclusion criteria for the screening phase:
    1. Non-CF lung disorder
    2. Age < 8 yrs of age or ≥ 18 yrs of age
    3. Body weight < 20 kg
    4. Not able to provide sputum sample
    5. Informed Consent not given

    Exclusion criteria for the intervention phase:
    1. Non-CF lung disorder
    2. Age < 8 yrs or ≥ 18 yrs
    3. Body weight < 20 kg
    4. Not able to perform lung function test (FEV1%)
    5. Unable to produce a sputum sample (spontaneous or induced sputum)
    6. Clinically unstable condition with significant change in lung function or significant worsening of respiratory symptoms
    7. Unable to tolerate oral medication
    8. Known hypersensitivity to itraconazole or posaconazole, or it’s excipients.
    9. On active transplant list or transplant recipient
    10. Azole resistant Aspergillus sp. cultured
    11. Patients receiving terfenadine, ergot alkaloids, astemizole, cisapride, pimozide, halofantrine, quinidine, or HMG-CoA reductase inhibitors metabolised through CYP3A4 (eg. simvastatin, lovastatin, and atorvastatin)
    12. Patients receiving omalizumab
    13. Received systemic mould-active antifungals in the last month
    14. Shortened or elongated QT interval
    15. Cardiac failure
    16. ALT ≥ 200 U/L
    17. AST ≥ 225 U/L
    18. Alkaline phosphatase ≥ 460 U/L
    19. Bilirubin ≥ 50 umol/L
    20. eGFR < 20 ml/min/1.73 m2 (calculated with the Schwartz formula)
    21. Patients with known glucose-galactose malabsorption problems
    22. Pregnancy2 or breastfeeding
    23. Females of childbearing age who do not intend to use contraception measures.
    24. Informed Consent not given
    Criterios de exclusión Fase de selección
    1. Sin diagnóstico de fibrosis quística
    2. Edad < 8 años o ≥ 18 años
    3. Peso corporal< 20 Kg
    4. Incapaz de producir una muestra de esputo
    5. No accede a firmar Consentimiento Informado

    Criterios de exclusión Fase de Intervención
    1. Sin diagnóstico de fibrosis quística
    2. Edad < 8 años o ≥ 18 años
    3. Peso corporal< 20 Kg
    4. Incapaz de realizar una prueba de función pulmonar (FEV1%)
    5. Incapaz de producir una muestra de esputo
    6. Situación clínica inestable con cambios significativos en la función pulmonar o empeoramiento significativo de los síntomas respiratorios
    7. Incapaz de tolerar medicación por vía oral
    8. Hipersensibilidad conocida a itraconazol, posaconazol y/o sus excipientes
    9. En lista de trasplante o paciente receptor de trasplante
    10. Cultivo de Aspergillus spp. resistente a los azólicos
    11. Pacientes a tratamiento con terfenadina, alcaloides del Centeno, astemizol, cisaprida, pimozida, halofantrina, quinidina o inhibidores de la HMG-CoA reductasa metabolizados por CYP3A4 (ej. simvastatina, lovastatina, y atorvastatina)
    12. Pacientes que reciban tratamiento con omalizumab
    13. Pacientes que hayan recibido antifúngicos sistémicos en el último mes
    14. Intervalo QT acortado o prolongado
    15. Fallo cardiaco
    16. ALT ≥ 200 U/L
    17. AST ≥ 225 U/L
    18. Fosfatasa alcalina ≥ 460 U/L
    19. Bilirrubina ≥ 50 umol/L
    20. eGFR < 20 ml/min/1.73 m2 (calculado con formula de Schwartz)
    21. Pacientes con problemas conocidos de malabsorción glucosa-galactosa
    22. Pacientes embarazadas o lactantes2
    23. Mujeres en edad fértil que no accedan a usar métodos anticonceptivos
    24. No acceder a firmar el Consentimiento Informado
    E.5 End points
    E.5.1Primary end point(s)
    - For the dosing algorithm: The number of children and adolescents with CF and Aspergillus infection aged 8 to 17 years reaching the pre-defined area under the concentration time curve (AUC) of posaconazole at the first assessment (between day 5 and 10) based on the adult reference concentrations for treatment of susceptible pathogens.
    - For clinical efficacy: The number of children with negative sputum sample for Aspergillus infection at 3 months.
    -Para el algoritmo de dosificación: el número de niños y adolescentes de 8 a 17 años con FQ e infección por Aspergillus que alcanzan el área bajo la curva de concentración-tiempo predefinida (AUC) de posaconazol en la primera evaluación (entre el día 5 y el 10), basado en las concentraciones de referencia para adultos para el tratamiento de patógenos susceptibles.

    - Para eficacia clínica: el número de niños con muestra de esputo negativa para infección por Aspergillus a los 3 meses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For the dosing algorithm: between day 5 and 10
    For clinical efficacy: 3 months
    -Para el algoritmo de dosificación: entre el día 5 y 10
    - Para eficacia clínica: 3 meses
    E.5.2Secondary end point(s)
    PK
    -The number of children and adolescents with CF and Aspergillus infection aged 8 to 17 years reaching the pre-defined area under the concentration time curve (AUC) of posaconazole at the second and third assessment (day 21-35, EOT) based on the adult reference concentrations for treatment of susceptible pathogens.
    Epidemiology, clinical efficacy and safety
    - The proportion of children and adolescents aged 8 to 17 years with CF who screened positive for Aspergillus infection
    - The proportion of participants experiencing AEs and SAEs
    - Dose-response relationships between posaconazole exposure and toxicity
    - Forced expiratory volume (FEV1) at 3, 6 and 12 months post randomisation to evaluate if posaconazole is beneficial for CF-related Aspergillus infection.
    - Aspergillus in the airways (positive sputum culture) 3, 6 and 12 months post randomisation to evaluate if posaconazole is able to clear CF-related Aspergillus infection.
    - Levels of Aspergillus specific IgG and IgE 3, 6 and 12 months post randomisation to evaluate if posaconazole is able to normalize those levels.
    - Airway inflammation as measured by proteome profiling of sputum at baseline and 3 months post randomisation to evaluate if posaconazole is able to dampen inflammation in CF-related Aspergillus infection.
    - Clinical disease severity (as measured by pulmonary exacerbation rate, days on antibiotics and corticosteroids, hospital admissions, change in FEV1, change in BMI, CT-chest abnormalities) 3, 6 and 12 months post randomisation to evaluate if posaconazole has a beneficial effect.
    - Patient reported outcomes 3, 6 and 12 months post randomisation to evaluate if posaconazole has a beneficial effect (validated CFQR).
    PK
    -El número de niños y adolescentes de 8 a 17 años con FQ e infección por Aspergillus que alcanzan el área bajo la curva de concentración-tiempo (AUC) predefinida de posaconazol en la segunda y tercera evaluación (día 21-35, Final de tratamiento) según la concentración de referencia de adultos para el tratamiento de patógenos susceptibles.

    Epidemiología, eficacia clínica y seguridad
    - La proporción de niños y adolescentes de 8 a 17 años con FQ que dieron positivo en la detección de la infección por Aspergillus.
    - La proporción de participantes que experimentan Acontecimientos Adversos y Acontecimiento Adversos Graves.
    - Relaciones dosis-respuesta entre exposición a posaconazol y toxicidad
    - Volumen espiratorio forzado (FEV1) a los 3, 6 y 12 meses después de la aleatorización para evaluar si el posaconazol es beneficioso para la infección por Aspergillus relacionada con la FQ.
    - Aspergillus en las vías respiratorias (cultivo de esputo positivo) 3, 6 y 12 meses después de la aleatorización para evaluar si posaconazol es capaz de eliminar la infección por Aspergillus relacionada con la FQ.
    - Niveles de IgG e IgE específicas de Aspergillus 3, 6 y 12 meses después de la aleatorización para evaluar si el posaconazol puede normalizar esos niveles.
    - Inflamación de las vías respiratorias medida por el perfil del proteoma del esputo al inicio del estudio y 3 meses después de la aleatorización para evaluar si el posaconazol puede atenuar la inflamación en la infección por Aspergillus relacionada con la FQ.
    - Gravedad clínica de la enfermedad (medida por la tasa de exacerbación pulmonar, días a tratamiento con antibióticos y corticosteroides, ingresos hospitalarios, cambio en la FEV1, cambio en el IMC, alteraciones en el TAC de tórax) 3, 6 y 12 meses después de la aleatorización para evaluar si el posaconazol tiene un efecto beneficioso .
    - Resultados reportados por los pacientes (PROs) 3, 6 y 12 meses después de la aleatorización para evaluar si posaconazol tiene un efecto beneficioso (Cuestionario CFQR validado).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 21-35
    3,6 y 12 months post-randomization
    Días 21-35
    3,6 y 12 meses post-aleatorización
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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 Yes
    E.8.2.3.1Comparator description
    mismo PEI con diferente formulazión
    same IMP with different formulation
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    France
    Germany
    Ireland
    Italy
    Netherlands
    Portugal
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Greece
    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
    Final data lock
    Cierre base datos
    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 months4
    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 months4
    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: 135
    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: 67
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 68
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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
    Children
    Menores
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 135
    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 Decision2022-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-02-21
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