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    Summary
    EudraCT Number:2020-004838-37
    Sponsor's Protocol Code Number:AloCELYVIR
    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:2022-07-11
    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 number2020-004838-37
    A.3Full title of the trial
    Phase IB clinical trial to assess the safety, tolerability, and preliminary efficacy of AloCELYVIR (Mesenchymal allogenic cells + ICOVIR-5) in children, adolescent and young adults with newly diagnosed diffuse intrinsic pointine glioma (DIPG) in combination with radiotherapy or medulloblastoma in relapse/progression in monotherapy.
    Ensayo clínico Fase Ib para evaluar la seguridad, tolerabilidad y la eficacia de AloCELYVIR (células mesénquimales alogénicas + Icovir-5) en niños adolescentes y adultos jóvenes con glioma difuso de la protuberancia (DIPG) de nuevo diagnóstico en combinación con radioterapia o meduloblastoma en recaída/ progresión en monoterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IB clinical trial to assess the safety, tolerability, and preliminary efficacy of AloCELYVIR in children, adolescent and young adults with diffuse intrinsic pointine glioma (DIPG) or medulloblastoma.
    Ensayo clínico Fase Ib para evaluar la seguridad, tolerabilidad y la eficacia de AloCELYVIR en niños, adolescentes y adultos jóvenes con glioma difuso de la protuberancia (DIPG) o meduloblastoma.
    A.3.2Name or abbreviated title of the trial where available
    FIBHNJ-2020-01
    FIBHNJ-2020-01
    A.4.1Sponsor's protocol code numberAloCELYVIR
    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 SponsorFundación de Investigación Biomédica Hospital Niño Jesús
    B.1.3.4CountrySpain
    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 supportFundación Cris Contra el Cáncer
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportFundación el Sueño de Vicky
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPICES SOLUCIONES S.L
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Antonio López 16, 1ºA
    B.5.3.2Town/ cityPinto, Madrid
    B.5.3.3Post code28320
    B.5.3.4CountrySpain
    B.5.4Telephone number+34918166804100
    B.5.6E-mailana.moreno@apices.es
    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 nameALOCELYVIR
    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 INNAlogenic bone marrow stem adult mesenchymal cells expanded Infected with Icovir-5
    D.3.9.2Current sponsor codeICOVIR-5
    D.3.9.3Other descriptive nameADENOVIRUS TYPE 5 VECTOR
    D.3.9.4EV Substance CodeSUB196201
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    Newly diagnosed Diffuse Intrinsic Pointine Glioma (DIPG) or Medulloblastoma in relapse/progression in children, adolescents and young adults.
    Glioma difuso de la protuberancia (DIPG) de nuevo diagnóstico y meduloblastoma en recaída/progresión en niños, adolescentes y adultos jóvenes.
    E.1.1.1Medical condition in easily understood language
    Glioma and medulloblastoma in children, adolescents and young adults.
    Glioma y meduloblastoma en niños, adolescentes y adultos jóvenes.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10066594
    E.1.2Term Medulloblastoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10080666
    E.1.2Term Diffuse intrinsic pontine glioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the safety of the combination of AloCelyvir and radiotherapy in patients with newly diagnosed DIPG.

    2. To evaluate the safety of AloCelyvir in monotherapy in patients with progression/relapse in medulloblastoma.
    1. Evaluar la seguridad de la combinación de AloCelyvir sumado a la radioterapia en pacientes con nuevo diagnóstico de DIPG.

    2. Evaluar la seguridad de AloCelyvir en monoterapia en pacientes con progresión/recaída en meduloblastoma.
    E.2.2Secondary objectives of the trial
    1. Measurement of antitumor activity (measured as objective response rate [complete response and partial response] of the combination/monotherapy)
    2. Feasibility of the combination/monotherapy
    3. Safety (expansion phase)
    4. Estimation of progression-free survival (PFS)
    5. Estimation of overall survival (OS)
    6. To compare the progression-free survival and overall survival of cohort A and B with a historical cohort of newly diagnosed DIPG patients and with a historical cohort of patients with relapse medulloblastoma.
    7. To study the antiadenoviral immune response in patients
    8. To Study the replication kinetics of Icovir-5
    1. Medida de la actividad antitumoral (medida como tasa de respuesta objetiva [respuesta completa y respuesta parcial] de la combinación/monoterapia)
    2. Viabilidad de la combinación/monoterapia
    3. Seguridad (fase de expansión)
    4. Estimación de la supervivencia libre de progresión
    5. Estimación de la supervivencia global
    6. Comparar la supervivencia libre de progresión y global de las cohortes A y B con una cohorte histórica de pacientes con DIPG de nuevo diagnóstico y una cohorte de pacientes con meduloblastoma en recaída/progresión.
    7. Estudiar la respuesta inmune antiadenoviral en los pacientes.
    8. Estudiar la cinética de replicación de Icovir-5.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    INCLUSION CRITERIA COMMON TO THE TWO COHORTS

    1. Patients aged 1 to 21 years.
    2. Written informed consent signed by the patient's legal representative and, if applicable, the minor (informed consent in patients 12 years of age or older).
    3. Measurable or evaluable disease according to RANO criteria.
    4. Appropriate functional status, organic function (renal, hepatic) and hematological values:
    o Lanksy and karnofsky functional status ≥50%. Patients who use a wheelchair due of tumor-associated paralysis will be considered as outpatients for functional status evaluation.
    o Haematology function:
    • Platelet count ≥75.000/µL (without support for 3 days)
    • Absolute neutrophil count (ANC) ≥500/ µL (without growth factor for 3 days)
    • Hemoglobin ≥ 8 g/dL (Transfusion allowed)
    o Liver and renal function
    • Glomerular filtration rate (GFR) (estimated by Schwartz ) >60 mL/min/1.73 m2
    • Total bilirubin ≤ 1.5 × the upper limit of normal (ULN)
    • Transaminases (GOT and GPT) ≤3 × the upper limit of normal (ULN). ≤ 5 times ULN for patients with hepatic metastasis.
    5. Patient able to comply with treatment and schedule of visits and assessments
    6. Life expectancy of ≥8 weeks.
    7. Highly effective contraceptive methods (Pearl rate <1) for sexually active males and females of childbearing age (CTFG, Reccomendations related to contraception and pregnancy in clinical trials V 1.1 2020--15). A woman is considered to have reproductive potential, i.e., childbearing, when she has reached menarche through menopause, unless she is permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy
    8. Highly sensitive negative pregnancy test in blood or urine for childbearing females.

    INCLUSION CRITERIA COMMON TO THE COHORT A

    1. Patient with new DIPG diagnosis (clinical, radiological, or histological in case a biopsy was performed before being included in the study).
    2. Not having received previous treatment with radiotherapy or chemotherapy.
    3. Patient able to receive radiotherapy

    INCLUSION CRITERIA COMMON TO THE COHORT B

    1. Patient diagnosed with relapsed and/or refractory medulloblastoma. Patients must have received at least surgery, radiation therapy and chemotherapy as part of standard treatment and have failed these treatments before they can participate in this study.
    2. To be recovered to ≤ G1 from the toxic effects according to CTCAE derived from the previous treatments, excluding ototoxicity, alopecia and peripheral neurotoxicity.
    CRITERIOS DE INCLUSION COMUNES A LAS DOS COHORTES:

    1. Pacientes con edades comprendidas entre 1 año y ≤ 21 años.
    2. Consentimiento informado por escrito y firmado por el representante legal del paciente y, si procede, del menor (asentimiento informado en pacientes de 12 años o más).
    3. Enfermedad medible o evaluable según criterios RANO31-33.
    4. Adecuados estado funcional, función orgánica (renal, hepática) y valores hematológicos:
    o Estado funcional de Lansky ≥50% y de Karnofsky ≥50%. Los pacientes que utilizan silla de ruedas por parálisis asociada al tumor se considerarán ambulatorios para la evaluación del estado funcional.
    o Función hematológica
    • Plaquetas ≥75.000/µL (sin soporte durante 3 días)
    • Neutrófilos totales ≥500/ µL (sin factor de crecimiento durante 3 días)
    • Hemoglobina ≥ 8 g/dL (transfusiones permitidas)
    o Función renal y hepática
    • Filtrado glomerular (estimada por Schwartz) >60 ml/min/1,73 m2.
    • Bilirrubina total ≤1,5 veces el valor alto de la normalidad.
    • Transaminasas (GOT y GPT) ≤3 veces el valor alto de la normalidad. En caso de pacientes con metástasis hepáticas ≤5 veces el valor alto de la normalidad
    5. Paciente capaz de cumplir con el tratamiento y plan de visitas y evaluaciones.
    6. Expectativa de vida ≥8 semanas.
    7. Métodos anticonceptivos altamente eficaces (índice Pearl <1) para los varones sexualmente activos y las mujeres en edad fértil.(CTFG, Indicaciones relacionadas con la contracepción y el embarazo en ensayos clínicos V 1.1 2020--15). Una mujer se considera con capacidad reproductiva, es decir, fértil, aquella que ha alcanzado la menarquia y hasta la menopausia, a menos que sea estéril de forma permanente. Los métodos de esterilización permanente incluyen histerectomía, salpingectomía bilateral y ooforectomía bilateral.
    8. Test de embarazo altamente sensible negativo en sangre u orina para las mujeres fértiles.

    CRITERIOS DE INCLUSION ESPECÍFICOS COHORTE A:

    1. Paciente con nuevo diagnóstico de DIPG (clínico, radiológico, o histológico en caso de que se le haya practicado una biopsia antes de ser incluido en el estudio)
    2. No haber recibido tratamiento previo con radioterapia o quimioterapia
    3. Paciente capaz de recibir radioterapia


    CRITERIOS DE INCLUSION ESPECÍFICOS COHORTE B:

    1. Paciente con diagnóstico de meduloblastoma en recaída y/o refractario. Los pacientes deben haber recibido como parte del tratamiento estándar al menos cirugía, radioterapia y quimioterapia y haber fracasado estos tratamientos antes de poder participar en este estudio.
    2. Estar recuperado a ≤ G1 de los efectos tóxicos según CTCAE derivados de los tratamientos previos, excluyendo ototoxidad, alopecia y neurotoxicidad periférica.
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA COMMON TO THE TWO COHORTS

    1. Previous treatment with Celyvir or AloCelyvir.
    2. Known active bacterial, viral, fungal or parasitic infection not controlled
    3. Known active Hepatitis B or C virus or VIH infection.
    4. If patients are treated with corticosteroids, they should be clinically stable and on stable or tapering doses of steroids for at least one week.
    5. To be receiving another anti-cancer treatment not foreseen in this protocol or to anticipate receiving it during the patient's participation in the same concomitant with the experimental treatment
    6. Clinically significant or uncontrolled serious active and past systemic diseases that may pose an added risk to the patient

    EXCLUSION CRITERIA COMMON TO THE COHORT A

    1. Spontaneous massive intratumoral bleeding. Patients with post-operative bleeding (in case of biopsy or surgery) may be included in the study provided that the bleeding is controlled. The same rule applies for other postoperative complications (infection, loss of cerebrospinal fluid, absence of wound closure, subdural collection ...)
    2. Patients who have previously received radiotherapy to the brain stem for another malignancy

    EXCLUSION CRITERIA COMMON TO THE COHORT B

    1. Washout period respect to previous treatments:
    - At least two weeks since the last dose of chemotherapy. For patients receiving low-dose metronomic oral chemotherapy, this period is at least one week.
    - At least four weeks since the autologous hematopoietic stem cell transplant
    - At least two weeks since the last focal radiotherapy or six weeks in case of cranio-spinal radiotherapy.
    - At least 2 weeks or 5 half-lifes (whichever occurs first) since the last dose of a biological or investigational treatment.
    CRITERIOS DE EXCLUSION COMUNES A LAS DOS COHORTES:

    1. Tratamiento previo con Celyvir o AloCelyvir
    2. Infección activa conocida bacteriana, viral, fúngica o parasitaria conocida no controlada
    3. Infección activa conocida por virus de hepatitis B o C o VIH
    4. Si los pacientes reciben tratamiento con corticoides, deberán estar clínicamente estables y con dosis de esteroides estables o en descenso durante al menos una semana
    5. Estar recibiendo otro tratamiento anticanceroso no previsto en este protocolo o prever que lo vaya a recibir durante la participación del paciente en el mismo concomitantemente con el tratamiento experimental
    6. Enfermedades sistémicas activas y pasadas graves clínicamente significativas o no controladas que puedan implicar un riesgo añadido para el paciente

    CRITERIOS DE EXCLUSIÓN ESPECÍFICOS COHORTE A:

    1. Sangrado espontáneo masivo intratumoral. Los pacientes con sangrado postoperatorio (en caso de biopsia o cirugía) podrán ser incluidos en el estudio siempre que se controle la hemorragia. La misma regla se aplica para las otras complicaciones postoperatorias (infección, pérdida de líquido cefalorraquídeo, ausencia de cierre de la herida, colección subdural ...)
    2. Pacientes que hayan recibido previamente radioterapia en el tronco cerebral por otra neoplasia

    CRITERIOS DE EXCLUSIÓN ESPECÍFICOS COHORTE B:

    1. Periodos de lavado respecto a tratamientos previos
    - Al menos dos semanas de la última dosis de quimioterapia. Para pacientes recibiendo quimioterapia oral metrónomica a bajas dosis, este periodo es de al menos una semana.
    - Al menos cuatro semanas desde el trasplante autólogo de progenitores hematopoyéticos
    - Al menos dos semanas desde la última radioterapia focal o seis semanas en caso de radioterapia craneoespinal
    - Al menos dos semanas o 5 vidas medias (el que ocurra antes) desde la última dosis de un tratamiento biológico o investigacional
    E.5 End points
    E.5.1Primary end point(s)
    1. Dose-Limiting Toxicities rate (DLTs)
    1. Tasa de toxicidades limitantes de dosis
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Every week during 4 weeks.
    1. Cada semana durante 4 semanas
    E.5.2Secondary end point(s)
    1. Objective response rate
    2. Rate of patients meeting selection criteria who can receive at least one cycle of Alo-Celyvir
    3. Progression-free survival (PFS)
    4. Overall survival
    5. To compare the progression-free survival and overall survival of cohort A and B with a historical cohort of newly diagnosed DIPG patients and with a historical cohort of patients with relapse medulloblastoma
    6. Adverse Events Rate
    7. Kinetics of anti-Adenovirus serotype 5 antibody titers
    8. Kinetics of the number of CD8 antiadenovirus T-lymphocytes
    9. Kinetics of circulating adenoviral particles
    1. Tasa de respuesta objetiva
    2. Tasa de pacientes que cumplen criterios de selección que pueden recibir al menos un ciclo de Alocelyvir
    3. Supervivencia libre de progresión
    4. Supervivencia global
    5. Comparación de la supervivencia libre de progresión y global de las cohortes A y B con una cohorte de pacientes con DIPG de nuevo diagnóstico y una cohorte de pacientes con meduloblastoma en recaída.
    6. Tasa de acontecimientos adversos
    7. Cinética de títulos de anticuerpos antiadenovirus serotipo 5
    8. Cinética del número de linfocitos T CD8 antiadenovirus
    9.Cinética de partículas adenovirales circulantes
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Every 12 weeks since the start of treatment until disease progression.
    2. Since the start of recruitment until the first dose of AloCelyvir.
    3. Every 12 weeks since the start of treatment until disease progression.
    4. Every 12 weeks since the start of treatment until death.
    5. Every 12 weeks since the start of treatment until disease progression.
    6. Every week during 8 weeks and at week 10 of study treatment.
    7. Every week during 8 weeks and at week 10 of study treatment.
    8. Every week during 8 weeks and at week 10 of study treatment.
    9. Every week during 8 weeks and at week 10 of study treatment.
    1. Cada 12 semanas desde el inicio del tratamiento hasta progresión de la enfermedad.
    2. Desde el inicio del reclutamiento hasta la primera dosis de Alocelyvir
    3. Cada 12 semanas desde el inicio del tratamiento hasta progresión de la enfermedad.
    4. Cada 12 semanas desde el inicio del tratamiento hasta fallecimiento.
    5. Cada 12 semanas desde el inicio del tratamiento hasta progresión de la enfermedad.
    6. Cada semana durante 8 semanas y en la semana 10 del tratamiento del estudio.
    7. Cada semana durante 8 semanas y en la semana 10 del tratamiento del estudio.
    8. Cada semana durante 8 semanas y en la semana 10 del tratamiento del estudio.
    9. Cada semana durante 8 semanas y en la semana 10 del tratamiento del 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety Phase IB study
    Estudio de seguridad fase IB .
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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) Last visit last patient
    (LVLS) Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 8
    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: 2
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    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
    An inclusion criteria is "Patients aged between 1 year and ≤21 years"
    Un criterio de inclusión es "Pacientes con edades comprendidas entre 1 año y ≤ 21 años"
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    Follow up of patientes included in the study
    Seguimiento de los pacientes incluidos en el 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 Decision2021-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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