Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-002098-86
    Sponsor's Protocol Code Number:BOFT-0520/PED
    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:2021-02-09
    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 number2020-002098-86
    A.3Full title of the trial
    Multi-centre, randomised, double blind, placebo-controlled, parallel, phase III study to assess the safety, tolerability and efficacy of Bilastine ophthalmic solution 0.6% in children
    Ensayo fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y paralelo para valorar la seguridad, tolerabilidad y eficacia de Bilastina solución oftálmica 0,6% en niños
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess the safety, tolerability and efficacy of Bilastine eye drops in children.
    Estudio clínico para evaluar la seguridad, tolerabilidad y eficacia de Bilastina gotas para ojos en niños.
    A.3.2Name or abbreviated title of the trial where available
    Bilastine ophthalmic solution 0.6% in children
    Bilastina solución oftálmica 0,6% en niños
    A.4.1Sponsor's protocol code numberBOFT-0520/PED
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/408/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFAES FARMA, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFAES FARMA, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic Science S.L.
    B.5.2Functional name of contact pointDepartamento de operaciones
    B.5.3 Address:
    B.5.3.1Street AddressAvinguda Josep Tarradelles, 8-10, 5º4ª
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08029
    B.5.3.4CountrySpain
    B.5.4Telephone number0034933511615
    B.5.5Fax number0034933496341
    B.5.6E-mailensayosclinicos@dynasolutions.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 nameBilastine
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOphthalmic use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBilastina
    D.3.9.1CAS number 202189-78-4
    D.3.9.3Other descriptive nameBILASTINE
    D.3.9.4EV Substance CodeSUB37845
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, solution
    D.8.4Route of administration of the placeboOphthalmic use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic conjunctivitis (AC)
    Conjuntivitis alérgica (CA)
    E.1.1.1Medical condition in easily understood language
    Allergic conjunctivitis (AC)
    Conjuntivitis alérgica (CA)
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001709
    E.1.2Term Allergic conjunctivitis
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of Bilastine ophthalmic solution 0.6% during long-term use in children
    Evaluar la seguridad de Bilastina solución oftálmica 0,6% durante el uso a largo plazo en niños
    E.2.2Secondary objectives of the trial
    1. To assess the ocular tolerability and potential discomfort of Bilastine ophthalmic solution 0.6% during long-term use in children.
    2. To assess the efficacy of Bilastine ophthalmic solution 0.6% in children.
    1. Evaluar la tolerabilidad ocular y potencial discomfort de Bilastina solución oftálmica 0,6% durante su uso a largo plazo en niños.
    2. Evaluar la eficacia de Bilastina solución oftálmica 0,6% en niños.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients from 2 to under 18 years of age at V1a.
    2. Documented history of allergic conjunctivitis before V1a.
    3. Documented positive skin prick test and/or positive validated IgE test to seasonal (e.g. grass, ragweed, and/ or tree pollen) and/or perennial allergen (e.g. cat dander, dog dander, dust mites and/ or cockroach) within 6 months before V1a or a positive skin prick test at V1a.
    4. Signs and symptoms of allergic conjunctivitis, i.e. tearing, itching and redness, that are likely to continue for the next weeks. Minimum score of four (in at least one eye) on an 11-item numeric rating scale, in at least one of three categories at V1a.
    5. Understanding of functioning and willingness to use e-diary at V1b and throughout study duration.
    6. Willing to comply in all aspects of the study, including:
    a) use of IMP from V1b to V5a
    b) attending scheduled visits and completing telephone interviews.
    7. Signed age-appropriate assent form (in participants 12 years of age and older) and written informed consent by the legally acceptable representative in all cases. If a patient turns 18 years old during the clinical trial, a new written informed consent form will be provided and signed by the patient if he/she is willing to continue participating in the study.
    8. Be able to self-administer eye drops satisfactorily or have a caregiver or legally acceptable representative routinely available for this purpose. If a caregiver or legally acceptable representative will be in charge of administering eye drops then he/she must attend Visit V1b, in order to be trained for administration of eye drops on-site.
    9. For females of childbearing potential only: willingness to perform pregnancy tests, acceptance to use highly effective methods of birth control throughout the study duration. Highly effective methods of birth control include: combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner (provided that partner is the sole sexual partner of the clinical trial participant and has documentation of azoospermia) or sexual abstinence (if defined as refraining from heterosexual intercourse during the entire period of risk associated with the clinical trial treatment). The investigator is responsible for determining whether the subject has adequate birth control for study participation.
    1. Pacientes hombres o mujeres de edades entre 2 y menos de 18 años en V1a.
    2. Antecedente documentado de conjuntivitis alérgica antes de V1a;
    3. Documentación de test cutáneo (skin prick test) positivo y/o IgE positiva para al menos un alergeno estacional (como césped, ambrosía y/o pólen de árbol) y/o perenne (como epitelio de gato o perro, ácaros y/o cucaracha) dentro de los 6 meses previos a V1a o un test cutáneo positivo en V1a;
    4. Signos y síntomas de conjuntivitis alérgica, como lagrimeo, prurito ocular y ojo rojo, que se prevé continuarán durante las siguientes semanas. Se requiere una puntuación mínima de cuatro (en al menos un ojo) en una escala numérica de 11 ítems, en al menos una de las tres categorías descritas en V1a;
    5. Comprensión del funcionamiento y disposición para usar el e-diario en V1b y durante el estudio;
    6. Disposición para cumplir en todos los aspectos del estudio, incluyendo:
    a) Uso del medicamento en investigación desde V1b a V5a
    b) Asistir a las visitas programadas y completar las entrevistas telefónicas;
    7. Firma del documento de asentimiento (en participantes con edad mayor o igual a 12 años) y firma del consentimiento informado por escrito por un representante legal autorizado en todos los casos. Si un paciente cumple los 18 años durante el ensayo clínico, se le proveerá un nuevo consentimiento informado, el cual debe ser firmado por el/la paciente en el caso esté de acuerdo con continuar su participación en el estudio;
    8. Tener la capacidad de auto-administrarse de forma satisfactoria gotas oftálmicas, o tener un cuidador/a o representante legal autorizado que pueda hacerlo. Si un cuidador/a o representante legal autorizado estará a cargo de la administración de las gotas oftálmicas, él/ella deberá asistir a la Visita V1b, para recibir el entrenamiento para la administración en la consulta;
    9. Sólo para mujeres en edad reproductiva: disponibilidad para realizar pruebas de embarazo; asimismo deben acceder al uso de métodos de control de natalidad altamente efectivos durante toda la duración del estudio. Los métodos de control de la natalidad altamente efectivos incluyen: anticonceptivos hormonales combinados asociados con inhibidores de la ovulación (oral, intravaginal o transdérmico), anticonceptivos hormonales de progesterona asociados con inhibidores de la ovulación (oral, inyectable o implantable), dispositivo intrauterino (DIU), sistema intrauterino de liberación hormonal, oclusión tubaria bilateral, pareja vasectomizada (en caso que dicha pareja sea la única pareja sexual de la participante en el ensayo y tenga documentación de azoospermia) o abstinencia sexual (definida como evitar relaciones sexuales heterosexuales durante todo el período de riesgo asociado al tratamiento del ensayo). El/la investigador/a es responsable de determinar si la paciente tiene un método de control de la natalidad adecuado para la participación en el estudio.
    E.4Principal exclusion criteria
    1. History of known contraindications or sensitivities to the use of the IMPs or any of their components.
    2. History of intraocular surgery within the previous 2 years before V1a, or planned surgery during study participation and within 2 weeks after follow-up.
    3. History of ocular trauma (within the previous 6 months before V1a).
    4. History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease within the previous year before V1a.
    5. History of any clinically significant external ocular disease within 30 days before V1a.
    6. Presence of dry eye, active blepharitis, active Meibomian gland dysfunction, active rosacea affecting the ocular surface/ lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect study outcome at V1a.
    7. Known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye).
    8. History of treatment failure to topical antihistamines.
    9. Prior (within 2 years before V1a), current or anticipated anti-allergy immunotherapy.
    10. Prior (within 4 weeks before V1a), current or anticipated corticosteroid treatment (systemic or local, in case of depot-corticosteroids: within 6 weeks before V1a).
    11. Prior (within 1 week before V1a), current or anticipated use of any ophthalmic agents (including artificial tears), except IMPs (starting at V1b).
    12. Wearing of contact lenses 24 hours before ophthalmologic tests (V1a) and during clinical trial participation until V6.
    13. Prior (within 2 weeks before V1a), current or anticipated systemic or intranasal treatment for allergic rhinitis.
    14. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
    15. Pregnant woman, breastfeeding woman or woman planning a pregnancy.
    16. Body weight below the 5th percentile for their age (patients 10 years of age or younger only). [Appendix 1: Table of Fifth (5th) Percentile Body Weight by Age]
    17. Patient has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before V1a or is currently enrolled in an investigational interventional study.
    18. Any condition that, in the opinion of the investigator, may jeopardise the clinical trial conduct according to the protocol. (For example, evidence of diseases, medications or laboratory abnormalities that could alter the conduct of the study).
    1. Antecedentes de contraindicaciones o sensibilidades conocidas para el uso del medicamento en investigación o cualquiera de sus componentes.
    2. Antecedente de cirugía intraocular dentro de los 2 años previos a V1a, o cirugía programada durante la participación en el estudio y hasta 2 semanas tras el seguimiento.
    3. Antecedente de traumatismo ocular (dentro de los 6 meses previos a V1a).
    4. Antecedente o evidencia clínica de herpes simple ocular o infección ocular por herpes zoster dentro del año previo a V1a.
    5. Antecedente de cualquier patología ocular externa clínicamente significativa dentro de los 30 días previos a V1a.
    6. Presencia de ojo seco, blefaritis activa, disfunción activa de glándula de Meibomio, rosácea activa que afecte la superficie ocular/margen del párpado, conjuntivitis folicular crónica o activa, adenopatía preauricular, o cualquier otra anormalidad ocular o periocular que pueda afectar los resultados del estudio en V1a.
    7. Antecedentes conocidos de síndrome de erosión corneal recurrente (idiopático o secundario a ojo seco).
    8. Antecedente de fracaso terapéutico a antihistamínicos tópicos.
    9. Inmunoterapia anti-alérgica previa (dentro de los 2 años antes de V1a), actual o programada.
    10. Tratamiento con corticosteroides previo (dentro de las 4 semanas previas a V1a), actual o anticipado (sistémico o local, en caso de corticosteroides de depósito: dentro de las 6 semanas previas antes de V1a).
    11. Uso de cualquier agente oftalmológico (incluyendo lágrimas artificiales) previo (dentro de 1 semana antes de V1a), actual o anticipado, excepto el medicamento en investigación (empezando en V1b).
    12. Uso de lentes de contacto 24 horas antes de las pruebas oftalmológicas (V1a) y durante la participación en el ensayo clínico hasta V6.
    13. Tratamiento sistémico o intranasal previo (2 semanas antes de V1a), actual o previsto para la rinitis alérgica.
    14. Personas ingresadas en una institución por orden de autoridades judiciales u otras.
    15. Mujeres embarazadas, en lactancia o que estén planeando un embarazo.
    16. Tener el peso corporal debajo del 5º percentil para la edad (solo en pacientes con edad menor o igual a 10 años).
    17. Administración de un producto en investigación (incluyendo vacunas en investigación) o uso de un dispositivo médico invasivo en investigación dentro de los 30 días previos a V1a o participación en un estudio de intervención al momento.
    18. Cualquier condición, que en la opinión del/de la investigador/a, puede comprometer el desarrollo del ensayo clínico de acuerdo al protocolo. (Por ejemplo, evidencia de enfermedad, uso de medicación o anomalías analíticas que podrían alterar el desarrollo del estudio).
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of related ocular treatment-emergent adverse events (ocular r-TEAEs).
    Incidencia de eventos adversos oculares relacionados al tratamiento (r-TEAEs oculares).
    E.5.1.1Timepoint(s) of evaluation of this end point
    During all the study
    Durante todo el estudio
    E.5.2Secondary end point(s)
    Secondary safety and tolerability endpoints:
    1. Incidence of treatment-emergent adverse events (TEAEs)
    2. Incidence of ocular treatment-emergent adverse events (ocular TEAEs)
    3. Incidence of related treatment-emergent adverse events (r-TEAEs)
    4. Incidence of abnormal clinical findings from ophthalmic examinations after instillation of IMP.
    Ophthalmic examination will consist of:
    • Best-corrected visual acuity test with age-appropriate techniques
    • Slit lamp biomicroscopy
    • Intraocular pressure in children who can cooperate with the test and do not require general anaesthesia
    • Non-dilated fundus examination
    5. Mean peak ocular discomfort score after on-site instillation of IMP
    6. Mean ocular burning, stinging, tearing, blurring and stickiness scores after on-site instillation of IMP
    Secondary efficacy endpoints:
    1. Absolute value as well as absolute and relative changes from baseline of average daily total eye symptoms score (TESS) over the entire 8-week treatment period
    2. Absolute value as well as absolute and relative changes from baseline of average daily TESS at each week of the 8-week treatment period
    3. Absolute value as well as absolute and relative changes from baseline of average daily itching, redness and tearing scores over the entire 8-week treatment period
    4. Absolute value as well as absolute and relative changes from baseline of average daily itching, redness and tearing scores at each week of the 8-week treatment period
    5. For SAC patients only, the average daily TESS over the 2-week period of peak total eye symptoms score
    6. For SAC patients only, the average daily itching, redness and tearing scores over the 2-week period of peak symptoms score
    Variables secundarias de seguridad:
    1. Incidencia de eventos adversos asociados al tratamiento (TEAEs)
    2. Incidencia de eventos adversos oculares asociados al tratamiento (ocular TEAEs)
    3. Incidencia de eventos adversos relacionados al tratamiento (r-TEAEs)
    4. Hallazgos clínicos de las pruebas oftalmológicas tras la instilación del medicamento en investigación
    Las pruebas oftalmológicas consistirán en:
    • Agudeza visual con la mejor corrección y con técnicas apropiadas para la edad
    • Biomicroscopia con lámpara de hendidura
    • Presión intraocular en niños que puedan cooperar con la prueba y no requieran anestesia general
    • Fundoscopia no dilatada
    5. Puntuación para el máximo discomfort ocular tras la instilación del medicamento en investigación en consulta
    6. Valor medio de las puntuaciones para sensación de ardor, escozor, lagrimeo, visión borrosa y sensación pegajosa en los ojos, tras la administración del medicamento en investigación en consulta.
    Variables secundarias de eficacia:
    1. Valor absoluto y cambios tanto absolutos como relativos con respecto al basal del promedio diario de la puntuación total de síntomas oculares - total eye symptoms score (TESS), durante todo el período de tratamiento de 8 semanas.
    2. Valor absoluto, así como cambios absolutos y relativos con respecto al basal del promedio de TESS diario para cada semana de las 8 semanas del período de tratamiento.
    3. Valor absoluto, así como cambios absolutos y relativos con respecto al basal en el promedio diario de las puntuaciones para prurito, ojo rojo y lagrimeo para todo el período de 8 semanas de tratamiento.
    4. Valor absoluto, así como cambios absolutos y relativos con respecto al basal en el promedio diario de las puntuaciones para prurito, ojo rojo y lagrimeo para cada semana de las 8 semanas del período de tratamiento.
    5. Sólo para pacientes con conjuntivitis alérgica estacional (CAE), el promedio diario del TESS en el período de 2 semanas con máxima sintomatología.
    6. Sólo para pacientes con conjuntivitis alérgica estacional (CAE), el promedio diario de las puntuaciones para prurito, ojo rojo y lagrimeo a lo largo del período de 2 semanas con máxima sintomatología.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During all the study
    Durante todo el estudio
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 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 concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 150
    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: 90
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    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 state150
    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)
    Treatment according to routine clinical practice
    Práctica clínica habitual
    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 Decision2020-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-30
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 18 20:02:10 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA