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    Summary
    EudraCT Number:2018-002093-42
    Sponsor's Protocol Code Number:SHP643-301
    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:2019-07-26
    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 number2018-002093-42
    A.3Full title of the trial
    SPRING STUDY: An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Subjects 2 to <12 Years of Age
    Estudio SPRING: Estudio de fase 3, abierto y multicéntrico para evaluar la seguridad, la farmacocinética y la farmacodinamia de lanadelumab para la prevención de las crisis agudas de angioedema hereditario (AEH) en pacientes pediátricos de 2 a menos de 12 años
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the safety of Lanadelumab to prevent episodes of severe swelling in children
    Estudio clínico para evaluar la seguridad de Lanadelumab para prevenir episodios de inflamación severa en niños
    A.3.2Name or abbreviated title of the trial where available
    Safety, Pharmacokinetics, and Pharmacodynamics Study of Lanadelumab to Prevent Hereditary Angioedema
    Seguridad, farmacocinética y farmacodinamia de lanadelumab para prevención de angioedema hereditario
    A.4.1Sponsor's protocol code numberSHP643-301
    A.5.4Other Identifiers
    Name:IND NumberNumber:116647
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShire (Shire is now part of Takeda)
    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 supportDyax Corp., a Takeda Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Pharmaceutical Company Limited
    B.5.2Functional name of contact pointRobert Bradley
    B.5.3 Address:
    B.5.3.1Street Address300 Shire Way
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1781 482 1638
    B.5.6E-mailrobert.bradley@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 Takhzyro
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceuticals Ireland, Ltd.
    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/3/15/1551
    D.3 Description of the IMP
    D.3.1Product nameLanadelumab
    D.3.2Product code TAK743; SHP643
    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 INNLANADELUMAB
    D.3.9.1CAS number 1426055-14-2
    D.3.9.2Current sponsor codeTAK743; SHP643
    D.3.9.3Other descriptive nameDX-2930
    D.3.9.4EV Substance CodeSUB189058
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Hereditary Angioedema (HAE)
    Angioedema hereditario
    E.1.1.1Medical condition in easily understood language
    HAE is a long-term and life-threatening disease. HAE manifests clinically as unpredictable, intermittent attacks of edema of the face, larynx, gastrointestinal tract, limbs and/or genitalia
    AEH:enfermedad a largo plazo y potencialmente mortal. Se manifiesta clínicamente como imprevisibles e intermitentes ataques de edema en cara,laringe,tracto gastrointestinal,extremidades y/o genitales.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10019860
    E.1.2Term Hereditary angioedema
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10075280
    E.1.2Term Hereditary angioedema attack
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the safety and pharmacokinetics (PK) of lanadelumab in children (2 to <12 years of age) with HAE.
    El objetivo principal del estudio es evaluar la seguridad y la farmacocinética (FC) de lanadelumab en niños (de
    2 a <12 años) con AEH.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    • To evaluate the clinical outcomes of lanadelumab in preventing HAE attacks in children (2 to <12 years of age) with HAE.
    • To characterize the pharmacodynamics (PD) of lanadelumab in children (2 to <12 years of age) with HAE.
    • To assess the immunogenicity of chronically administered lanadelumab and its effect on PK, PD, clinical outcomes, and safety.

    The exploratory objectives are:
    • To evaluate the effect of lanadelumab on health-related quality of life (HRQoL).
    • To evaluate the effect of lanadelumab on exploratory biomarker(s) of angioedema disease-state bioactivity.
    Los objetivos secundarios del estudio son:
    • Evaluar la actividad clínica o los resultados (denominados en lo sucesivo resultados clínicos) de lanadelumab en la prevención de las crisis de AEH en niños (de 2 a <12 años) con AEH.
    • Caracterizar la farmacodinamia (FD) de lanadelumab en niños (de 2 a <12 años) con AEH.
    • Evaluar la inmunogenicidad de lanadelumab administrado a largo plazo y su efecto sobre la FC, la FD, los resultados clínicos y la seguridad en niños (de 2 a <12 años) con AEH.
    Los objetivos exploratorios son:
    • Evaluar el efecto de lanadelumab sobre la calidad de vida relacionada con la salud (CVRS).
    • Evaluar el efecto de lanadelumab sobre el inhibidor de la esterasa C1 (C1-INH), C4 y los biomarcadores
    exploratorios de bioactividad del estado patológico del angioedema.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be a child (male or female) 2 to <12 years of age at the time of screening.
    2. Documented diagnosis of HAE (Type I or II) based upon all of the following:
    • Documented clinical history consistent with HAE (SC or mucosal, nonpruritic swelling episodes without accompanying urticaria);
    • A family history consistent with HAE Type I or II, or C1q within normal range;
    • Diagnostic testing results obtained during screening from a sponsor-approved central laboratory that confirm C1-INH functional level <40% of the normal level. Subjects with functional C1-INH level 40-50% of the normal level may be enrolled if they also have a C4 level below the normal range. With prior sponsor approval, subjects may be retested during the baseline observation period if results are incongruent with clinical history or believed by the investigator to be confounded by recent C1 inhibitor use.
    3. A historical baseline HAE attack rate of at least 1 attack per 3 months. Note: In addition, subjects who experience ≥1.0 angioedema attacks per three months during the 12-week baseline observation period and who remain eligible per the inclusion criteria will enter the lanadelumab treatment period.
    4. Agree to adhere to the protocol-defined schedule of treatments, assessments, and procedures.
    5. Have a parent(s)/legal guardian who is informed of the nature of the study and can provide written informed consent for the child to participate in the study before any study-specific procedures are performed (with assent from the child when appropriate).
    6. Females of childbearing potential must agree to be abstinent or agree to comply with the applicable contraceptive requirements of this protocol through the duration of the study from screening through 70 days after the final study visit.
    1. Ser un niño (de sexo masculino o femenino) de 2 a <12 años de edad en el momento de la firma del documento de consentimiento informado (selección).
    2. Diagnóstico documentado de AEH (tipo I o II) basado en todos los criterios siguientes:
    • Antecedentes clínicos documentados compatibles con AEH (episodios de edema subcutáneo o
    mucosal no pruriginoso no acompañados de urticaria).
    • Antecedentes familiares compatibles con AEH de tipo I o II, o C1q dentro del intervalo normal.
    • Resultados de pruebas diagnósticas obtenidos durante la selección en un laboratorio central autorizado por el promotor que confirmen una concentración funcional de inhibidor de la esterasa C1 (C1-INH) <40 % de la concentración normal. Podrán participar los pacientes con una concentración funcional de C1-INH del 40-50 % de la concentración normal si también presentan una concentración de C4 por debajo del intervalo normal. Con la aprobación previa del promotor, se
    podrá volver a evaluar a los pacientes durante el período de observación basal si los resultados son incongruentes con los antecedentes clínicos o si el investigador considera que el uso reciente de inhibidores de C1 puede suponer un factor de confusión.
    3. Tasa basal histórica de crisis de AEH de al menos 1 crisis cada 3 meses. Nota: Además, los pacientes que experimenten ≥1,0 crisis de angioedema cada tres meses durante el período de observación basal de 12 semanas y que sigan siendo elegibles conforme a los criterios de inclusión entrarán en el período de
    tratamiento con lanadelumab.
    4. Comprometerse a cumplir el calendario de tratamientos, valoraciones y procedimientos definido en el protocolo.
    5. Otorgar el consentimiento informado por escrito por parte de un progenitor (o ambos)/tutor legal que esté
    informado de la naturaleza del estudio para que el niño participe en el mismo antes de que se lleve a cabo
    ningún procedimiento específico del estudio (con el asentimiento del niño cuando proceda).
    6. Las mujeres en edad fértil deberán comprometerse a practicar la abstinencia o a cumplir los requisitos de
    anticoncepción correspondientes de este protocolo durante todo el estudio, desde la selección hasta 70 días después de la visita final del estudio.
    E.4Principal exclusion criteria
    1. Concomitant diagnosis of another form of chronic, recurrent angioedema, such as acquired angioedema (AAE), HAE with normal C1-INH, idiopathic angioedema, or recurrent angioedema associated with urticaria.
    2. Dosing with an investigational drug or exposure to an investigational device within 4 weeks prior to screening.
    3. Be pregnant or breastfeeding.
    4. Have initiated androgen treatment (eg, stanozolol, danazol, oxandrolone, methyltestosterone, and testosterone) within 2 weeks prior to entering the observation period.
    5. Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks prior to screening.
    6. Have any active infectious illness or fever defined as an oral temperature >38°C (100.4°F), tympanic >38.5°C (101.3°F), axillary >38°C (100.4°F), or rectal/core >38.5°C (101.3°F) within 24 hours prior to the first dose of study drug in Treatment Period A.
    7. Have any HAE attack that is not resolved prior to the first dose of study drug in Treatment Period A.
    8. Have any of the following liver function test abnormalities: alanine aminotransferase (ALT) >3x upper limit of normal (ULN), or aspartate aminotransferase (AST) >3x ULNl, or total bilirubin >2x ULN (unless the bilirubin elevation is a result of Gilbert’s syndrome).
    9. Have any condition (any surgical or medical condition) that, in the opinion of the investigator or sponsor, may compromise their safety or compliance, preclude the successful conduct of the study, or interfere with interpretation of the results (eg, significant pre-existing illness or other major comorbidity that the investigator considers may confound the interpretation of study results).
    1. Diagnóstico concomitante de otra forma de angioedema recurrente crónico, como angioedema adquirido
    (AEA), AEH con concentración de C1-INH normal, angioedema idiopático o angioedema recurrente asociado a urticaria.
    2. Administración de un fármaco en investigación o exposición a un dispositivo en investigación durante las 4 semanas previas a la selección.
    3. Estar embarazada o en periodo de lactancia.
    4. Haber iniciado tratamiento androgénico (p. ej., estanozolol, danazol, oxandrolona, metiltestosterona y testosterona) durante las 2 semanas previas a la entrada en el período de observación.
    5. Exposición a inhibidores de la enzima convertidora de angiotensina (ECA) o a medicamentos que contengan estrógenos con absorción sistémica (como anticonceptivos orales o tratamiento hormonal sustitutivo) en las 4 semanas previas a la selección.
    6. Cualquier enfermedad infecciosa activa o fiebre definida como temperatura oral >38 °C, timpánica >38,5 °C, axilar >38 °C o rectal/central >38,5 °C durante las 24 horas previas a la primera dosis del fármaco del estudio en el período de tratamiento A.
    7. Cualquier crisis de AEH que no se haya resuelto antes de la primera dosis del fármaco del estudio en el
    período de tratamiento A.
    8. Presentar alguna de las siguientes anomalías en las pruebas de la función hepática: alanina aminotransferasa (ALT) >3 veces el límite superior de la normalidad, o aspartato aminotransferasa (AST) >3 veces el límite superior de la normalidad, o bilirrubina total >2 veces el límite superior de la normalidad (a menos que la elevación de la bilirrubina sea consecuencia del síndrome de Gilbert).
    9. Presentar cualquier afección (cualquier proceso quirúrgico o médico) que, en opinión del investigador o el promotor, pueda comprometer su seguridad o el cumplimiento del tratamiento, impedir la realización satisfactoria del estudio o interferir en la interpretación de los resultados (p. ej., enfermedad preexistente significativa u otra comorbilidad importante que el investigador considere que puede confundir la
    interpretación de los resultados del estudio).
    E.5 End points
    E.5.1Primary end point(s)
    Measures of safety include:
    • Adverse events including SAEs and AESI.
    • Clinical laboratory testing (hematology, clinical chemistry, coagulation)
    • Vital signs including blood pressure, heart rate, body temperature, and respiratory rate.

    Measures of PK include:
    • Plasma concentrations of lanadelumab
    • PK parameters in plasma, by age group, will be determined by a modelling and simulation approach and reported separately:
    o Cmax,ss: Maximum observed concentration at steady state
    o Cavg,ss: Average concentration over dosing interval at steady state
    o Ctrough,ss: Predose concentration at steady state
    o tmax: Time to reach Cmax in plasma
    o AUCtau,ss: Area under the concentration-time curve over the dosing interval at steady state
    o t½: Terminal half-life
    o CL/F: Apparent clearance
    o V/F: Apparent volume of distribution
    Las variables de seguridad serán:
    • Acontecimientos adversos (AA), incluidos acontecimientos adversos graves (AAG) y acontecimientos
    adversos de interés especial (AAIE).
    • Análisis clínicos (hematología, bioquímica clínica, coagulación).
    • Las constantes vitales medidas incluirán presión arterial, frecuencia cardíaca, temperatura corporal y frecuencia respiratoria.

    Los criterios de valoración de la FC son:
    • Concentraciones plasmáticas de lanadelumab durante el período de tratamiento.
    • Los parámetros FC en plasma, por grupo de edad, se calcularán mediante un modelo poblacional y un
    método de simulación, y se notificarán por separado:
    o Cmáx.,ee: concentración máxima observada en estado de equilibrio.
    o Cmedia,ee: concentración media durante el intervalo de administración en estado de equilibrio.
    o Cvalle,ee: concentración previa a la dosis en estado de equilibrio.
    o tmáx.: tiempo hasta alcanzar la Cmáx. en plasma.
    o AUCtau,ee: área bajo la curva de concentración frente a tiempo durante el intervalo de
    administración en estado de equilibrio.
    o t½: semivida terminal.
    o CL/F: aclaramiento aparente.
    o V/F: volumen aparente de distribución.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Overall treatment period (Day 0 [after study drug administration] through Day 364 [Week 52])
    • Treatment Period A (Day 0 [after study drug administration] through Day 182 [Week 26])
    • Treatment Period B (Day 183 through Day 364 [Week 52])
    • Overall presumed steady state period (Day 70 [Week 10] through Day 364 [Week 52])
    • Presumed steady state period for Treatment Period A (Day 70 [Week 10] through Day 182 [Week 26]).
    - período de tratamiento completo (día 0 (después de la administración del fármaco del estudio) a día 364 (semana52))
    -período de tratamiento A (día 0 (después de la administración del fármaco del estudio) a día 182 (semana26))
    -período de tratamiento B (día 183 a día 364 (semana52))
    - período completo supuesto de estado de equilibrio (día 70(semana10) a día 364(semana52))
    -período supuesto de estado de equilibrio para el período de tratamiento A (día 70(semana10) a día 182 (semana26))
    E.5.2Secondary end point(s)
    • Normalized number of investigator-confirmed HAE attacks.
    • Time to the first attack, ie, duration that a subject is attack-free until their first attack.
    • Normalized number of investigator-confirmed HAE attacks requiring acute therapy use.
    • Normalized number of moderate or severe investigator-confirmed HAE attacks.
    • Normalized number of high morbidity investigator-confirmed HAE attacks.
    • Characteristics of investigator-confirmed HAE attacks, including duration, severity, attack location, and rescue medication use.
    • Achievement of attack-free status.
    • Plasma kallikrein activity (as measured by cHMWK level).
    -Número normalizado de crisis de AEH confirmadas por el investigador
    -Tiempo hasta la primera crisis, es decir, duración que un sujeto está libre de ataques hasta su primer ataque
    -Número normalizado de crisis de AEH confirmadas por el investigador que requieren uso agudo de la terapia
    -Número normalizado de crisis de AEH moderadas o graves confirmadas por el investigador
    -Número normalizado de crisis de AEH de morbilidad elevada confirmadas por el investigador Características de las crisis de AEH confirmadas por el investigador incluidas duración, intensidad, localización de la crisis y uso de medicación de rescate.
    -Consecución de estado sin crisis
    -Actividad plasmática de calicreína (medida por el nivel cHMWK)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Overall treatment period (Day 0 [after study drug administration] through Day 364 [Week 52])
    • Treatment Period A (Day 0 [after study drug administration] through Day 182 [Week 26])
    • Treatment Period B (Day 183 through Day 364 [Week 52])
    • Overall presumed steady state period (Day 70 [Week 10] through Day 364 [Week 52])
    • Presumed steady state period for Treatment Period A (Day 70 [Week 10] through Day 182 [Week 26]).
    - período de tratamiento completo (día 0 (después de la administración del fármaco del estudio) a día 364 (semana52))
    -período de tratamiento A (día 0 (después de la administración del fármaco del estudio) a día 182 (semana26))
    -período de tratamiento B (día 183 a día 364 (semana52))
    - período completo supuesto de estado de equilibrio (día 70(semana10) a día 364(semana52))
    -período supuesto de estado de equilibrio para el período de tratamiento A (día 70(semana10) a día 182 (semana26))
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) 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.8.2.4Number of treatment arms in the trial2
    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 EEA5
    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
    Canada
    Germany
    Hungary
    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 Study Completion Date is defined as the date on which the last subject in the study completes the final protocol-defined assessment(s). This includes the follow-up visit or contact, whichever is later.
    La Fecha de finalización del estudio se define como la fecha en la que el último sujeto en el estudio completa la evaluación final definida por el protocolo. Esto incluye la visita de seguimiento o contacto, lo que sea posterior.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 20
    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: 20
    F.1.1.6Adolescents (12-17 years) No
    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 No
    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
    Pediatric patients
    Pacientes pediátricos
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9
    F.4.2.2In the whole clinical trial 20
    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)
    No aftercare is planned for this study.
    No se han planeado cuidados posteriores para este estudio.
    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 Decision2019-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-30
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