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    Summary
    EudraCT Number:2016-002972-29
    Sponsor's Protocol Code Number:CART19-BE-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-04
    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 number2016-002972-29
    A.3Full title of the trial
    Pilot study on the infusion of differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z (ARI-0001 cells) in patients with CD19+ leukemia or lymphoma refractory to therapy
    Estudio piloto de la infusión de linfocitos T diferenciados autólogos de sangre periférica expandidos y transducidos con un lentivirus para expresar un receptor antigénico quimérico con especificidad anti-CD19 (A3B1) conjugado con las regiones coestimuladoras 4-1BB y CD3z (células ARI-0001) en pacientes con leucemia o linfoma CD19+ resistente o refractaria a tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study on the infusion of ARI-0001 cells in patients with CD19+ leukemia or lymphoma refractory to therapy
    Estudio piloto de la infusión de células ARI-0001en pacientes con leucemia o linfoma CD19+ resistente o refractaria a tratamiento
    A.3.2Name or abbreviated title of the trial where available
    CART19-BE-01
    CART19-BE-01
    A.4.1Sponsor's protocol code numberCART19-BE-01
    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 SponsorIDIBAPS
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clínic
    B.5.2Functional name of contact pointJudit Pich Martinez
    B.5.3 Address:
    B.5.3.1Street AddressMallorca, 183 sotano despacho 58, Entregar de 9 a 17h
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+349322754002946
    B.5.5Fax number+34932279877
    B.5.6E-mailjdelgado@clinic.cat
    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 nameARI-0001
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with a
    D.3.9.2Current sponsor codeARI-0001
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 10
    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 Yes
    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 Yes
    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
    Patients with leukemia or lymphoma refractory to therapy
    Pacientes con leucemia o linfoma resistente o refractaria al tratamiento
    E.1.1.1Medical condition in easily understood language
    Leukemia o lymphoma
    Leucemia o linfoma
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10061275
    E.1.2Term Mantle cell lymphoma
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10008957
    E.1.2Term Chronic lymphatic leukemia
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10029473
    E.1.2Term Nodular (follicular) lymphoma
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10000843
    E.1.2Term Acute lymphatic leukemia
    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
    To assess the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity [A3B1] conjugated with the co-stimulatory regions 4-1BB and CD3z ) safety on patients with leukemia or lymphoma CD19+ resistant or refractory to treatment and with a prognosis of less than 2 years.
    Evaluar la seguridad de la infusión de células ARI-0001 (linfocitos T diferenciadas adultas
    autólogas de sangre periférica expandidas y transducidas con un lentivirus para expresar un
    receptor antigénico quimérico con especificidad anti-CD19 [A3B1] conjugado con las regiones
    coestimuladoras 4-1BB y CD3z) en pacientes con leucemia o linfoma CD19+ resistente o
    refractario al tratamiento y con un pronóstico inferior a 2 años
    E.2.2Secondary objectives of the trial
    • Evaluate the infusion of ARI-0001 effectiveness
    • Evaluate the duration of the infusion of ARI-0001
    • Evaluate the overall survival after the infusion of ARI-0001
    • Evaluate the duration of ARI-0001 cells in peripheral blood, bone marrow and CSF after administration
    • Evaluate the effect of ARI-0001 treatment on patients quality of life
    • Assess adverse events occurring at 3 months and at the first year.
    Evaluar la eficacia de la infusión de ARI-0001
    • Evaluar la duración de la respuesta tras la infusión de ARI-0001
    • Evaluar la supervivencia global tras la infusión de ARI-0001
    • Evaluar la duración de las células ARI-0001 en sangre periférica, médula ósea y LCR tras
    su administración
    • Evaluar el efecto del tratamiento con ARI-0001 sobre la calidad de vida de los pacientes
    • Evaluar los acontecimientos adversos ocurridos a los 3 meses y al año
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of leukemia or CD19 + lymphoma, with a life expectancy less than 2 years that meet the following conditions:
    Adult acute lymphoid leukemia in second or third response, not candidate for transplantation due to age, associated diseases or lack of donor, or in relapse post allogeneic transplant.
    Pediatric acute lymphoid leukemia in second or third response, refractory or non-transplant candidate due to donor absence, or in relapse post allogeneic transplant, or with minimal residual residual disease (0.1% or greater) after two or more lines of treatment.
    Symptomatic follicular lymphoma, which has received at least 2 treatment regimens (one of them including rituximab) and a progression-free interval of less than 2 years. Patients not candidates for transplantation or post-transplant relapse may be included.
    Symptomatic chronic lymphocytic leukemia, which has received at least 2 treatment regimens (one of them including rituximab) and a progression-free survival of less than 2 years. Patients with a 17p deletion or TP53 mutation may be included after the first line of treatment.
    Mantle cell lymphoma in the first relapse (or higher) when it is not a candidate for transplantation, or second post-transplant relapse (or higher).
    Diffuse large cell lymphoma in first relapse (or higher) when it is not a candidate for transplantation, or second post-transplant relapse (or higher).
    2. Age greater than 2 years and less than 80.
    3. ECOG functional status from 0 to 2 (Annex II).
    4. Life expectancy of at least 3 months.
    5. Appropriate venous access to perform an apheresis procedure. Absence of contraindications for it.
    6. Signature of informed consent (patient or legal guardian).
    1. Diagnóstico de leucemia o linfoma CD19+, con un pronóstico vital inferior a 2 años que
    cumplan con las siguientes condiciones:
    - Leucemia linfoide aguda del adulto en segunda o tercera respuesta, no candidato a
    trasplante por edad, enfermedades asociadas o ausencia de donante, o en recaída posttrasplante
    alogénico.
    - Leucemia linfoide aguda pediátrica en segunda o tercera respuesta, refractaria o no
    candidato a trasplante por ausencia de donante, o en recaída post-trasplante alogénico,
    o enfermedad mínima residual elevada (0,1% o mayor) tras dos o más líneas de
    tratamiento.
    - Linfoma folicular sintomático, que ha recibido al menos 2 esquemas de tratamiento (uno
    de ellos incluyendo rituximab) y con un intervalo libre de progresión inferior a 2 años.
    Podrán incluirse pacientes no candidatos a trasplante o en recaída post-trasplante.
    - Leucemia linfática crónica sintomática, que al menos ha recibido 2 esquemas de
    tratamiento (uno de ellos incluyendo rituximab) y con un intervalo libre de progresión
    inferior a 2 años. Los pacientes con deleción de 17p o mutación de TP53 podrán incluirse
    tras la primera línea de tratamiento.
    - Linfoma del manto en primera recaída (o superior) que no es candidato a trasplante, o
    bien en segunda recaída (o superior) post-trasplante.
    - Linfoma difuso de células grandes en primera recaída (o superior) que no es candidato a
    trasplante, o bien en segunda recaída (o superior) post-trasplante.
    2. Edad superior a 2 años e inferior a 80 años.
    3. Estado funcional ECOG de 0 a 2 (Anexo II).
    4. Esperanza de vida de al menos 3 meses.
    5. Acceso venoso adecuado para realizar una linfoaféresis. Ausencia de contraindicaciones
    para la misma.
    6. Firma del consentimiento informado (paciente o tutor legal).
    E.4Principal exclusion criteria
    1. Treatment with any experimental or non-marketed substance within four weeks prior to recruitment, or actively participating in another therapeutic clinical trial.
    2. Diagnosis of another past or present neoplasm. Patients may be included in complete remission for more than 3 years, or with a history of non-melanoma skin cancer or completely resected in-situ carcinoma.
    3. Central nervous system involvement (CNS-3) at inclusion. Inclusion will be permitted with patients with a lower grade (CNS-2) or with CNS-3 who have responded to intrathecal chemotherapy.
    4. Early relapse after allogeneic transplantation (less than 3 months for apheresis of mononuclear cells, less than 6 months for infusion of ARI-0001) or patients on active immunosuppressive therapy for graft-versus-host disease (corticosteroids or other systemic immunosuppressants ).
    5. Active infection requiring systemic medical treatment such as chronic kidney infection, chronic lung infection or tuberculosis.
    6. HIV infection.
    7. Concurrent and uncontrolled medical illnesses including cardiac, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological or psychiatric diseases which in the opinion of the researcher represent a risk to the patient.
    8. Positive serology for hepatitis B, defined as a positive test for HBsAg. In addition, if the patient is HBsAg negative but has anti-HBc antibodies it will be necessary to perform a DNA test of the hepatitis B virus, and if the result is positive the patient will be excluded.
    9. Positive serology for hepatitis C, defined as a positive test for anti-HCV antibodies confirmed by RIBA.
    10. Severe organ failure, defined as a cardiac ejection fraction <40%; DLCO <40%; calculated glomerular filtrate rate <30 ml / min; Or bilirubin> 3 times the upper limit of normal (unless it is due to CLL or Gilbert syndrome).
    11. Pregnant or lactating women. Women of childbearing potential should have a negative pregnancy test in the screening phase.
    12. Women of childbearing age, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective contraceptive methods * from the start of the study to the end of the study.
    13. Men who are unable or unwilling to use highly effective contraceptive methods * from the start of the study to the completion of the study.
    14. The need to take glucocorticoids in a chronic manner at doses higher than 10 mg / day of prednisone (or equivalent) or other chronic immunosuppressants.

    * Hormonal contraceptives, intrauterine device, intrauterine systems of hormonal release, sexual abstinence, vasectomy of the couple or bilateral tubal occlusion.
    1. Tratamiento con cualquier sustancia experimental o no comercializada en las cuatro
    semanas previas al reclutamiento, o que esté participando activamente en otro ensayo
    clínico terapéutico.
    2. Diagnóstico de otra neoplasia, pasada o actual. Podrán incluirse pacientes que lleven en
    remisión completa más de 3 años, o con antecedentes de cáncer cutáneo no melanoma o
    carcinoma in situ resecado completamente.
    3. Afectación franca del sistema nervioso central (SNC-3) en el momento de la inclusión. Se
    permitirá la inclusión con pacientes con un grado menor (SNC-2) o con SNC-3 que haya
    respondido a quimioterapia intratecal.
    4. Recaída precoz tras trasplante alogénico (menos de 3 meses para la aféresis de células
    mononucleadas, menos de 6 meses para la infusión de ARI-0001) o pacientes que estén en
    tratamiento inmunosupresor activo por enfermedad injerto contra huésped (corticoides u
    otros inmunosupresores sistémicos).
    5. Infección activa que requiere tratamiento médico sistémico como, por ejemplo, infección
    renal crónica, infección pulmonar crónica o tuberculosis.
    6. Infección por VIH.
    7. Enfermedades médicas concurrentes e incontroladas incluyendo enfermedades cardiacas,
    renales, hepáticas, gastrointestinales, endocrinas, pulmonares, neurológicas o
    psiquiátricas que en opinión del investigador supongan un riesgo para el paciente.
    8. Serología positiva para hepatitis B, definida como prueba positiva para HBsAg. Además, si
    el paciente es HBsAg negativo pero tiene anticuerpos anti-HBc será necesario realizar un
    test de ADN del virus de la hepatitis B, y si el resultado es positivo el paciente será
    excluido.
    9. Serología positiva para hepatitis C, definida como prueba positiva para anticuerpos anti-
    VHC que se confirma mediante RIBA.
    10. Afectación orgánica grave, definida como fracción de eyección cardíaca <40%; DLCO
    <40%; filtrado glomerular calculado <30 ml/min; o bilirrubina > 3 veces el límite superior
    de la normalidad (a menos que se deba a la LLC o a un síndrome de Gilbert).
    11. Mujeres embarazadas o lactando. Las mujeres en edad fértil deberán tener una prueba
    de embarazo negativa en la fase de screening.
    12. Mujeres en edad fértil, incluyendo aquellas cuyo último ciclo menstrual fue en el año
    previo al cribado, que no puedan o no deseen emplear métodos anticonceptivos
    altamente eficaces* desde el inicio del estudio hasta la finalización del mismo.
    13. Varones que no puedan o no deseen emplear métodos anticonceptivos altamente
    eficaces* desde el inicio del estudio hasta la finalización del mismo.
    14. Necesidad de tomar glucocorticoides de manera crónica en dosis superior a 10 mg/día de
    prednisona (o equivalentes) u otros inmunosupresores crónicos.
    * anticonceptivos hormonales, dispositivo intrauterino, sistemas intrauterino de liberación hormonal,
    abstinencia sexual, vasectomía de la pareja o oclusión tubárica bilateral.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the infusion of ARI-0001 cells safety on the basis of the following parameters:
    - Procedure-related mortality (PRM) at the first and third year, defined as any death not caused directly by leukemia / lymphoma. For the estimation of PRM, relapse or progression of the disease will be considered as a competitive event.
    - Assessment of toxicity at 3 months and first year, defined as number of adverse events grade III-IV using CTC (common toxicity criteria) version 3.0. Particular attention will be paid to cytokine release syndrome, neurological toxicity and the occurrence of second malignancies.
    Evaluar la seguridad de la infusión de células ARI-0001 en base a los siguientes parámetros:
    - Mortalidad relacionada con el procedimiento (MRP) al año y los 3 años, definida como
    cualquier fallecimiento no causado directamente por la leucemia/linfoma. Para la
    estimación de la MRP se considerará la recaída o progresión de la enfermedad como un
    evento competitivo.
    - Evaluación de la toxicidad a los 3 meses y al año, definida como número de
    acontecimientos adversos grado III-IV empleando los CTC (common toxicity criteria)
    versión 3.0. Se prestará especial atención al síndrome de liberación de citocinas, la
    toxicidad neurológica y a la aparición de segundas neoplasias.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 3, year 1 and year 3
    Mes 3, 1 año y 3 años
    E.5.2Secondary end point(s)
    - Response rate (overall and complete) at 3 months and first year, defined differently for each disease.
    o On chronic lymphoid and acute lymphocytic leukemia, the usual criteria NCCN and IWCLL will be used.
    o On non-Hodgkin's lymphoma, the Lugano criteria will be used.
    o On patients with leukemia will be quantified the persistence of minimal residual disease, in bone marrow and peripheral blood, using multiparametric cytometry and new generation sequencing techniques.
    - Progression-free survival at 2 years after the procedure, defined as the time lag between infusion of ARI-0001 and the progression of disease or death. Patients alive and in complete remission will be censored at the last follow-up.
    - Overall survival (OS) at 2 years, defined as the time lag between the infusion of ARI-0001 and the death of the patient from any cause. Living patients will be censored at the the last follow-up.
    - In vivo survival of ARI-0001 cells in peripheral blood, bone marrow and cerebrospinal fluid, determined, monthly during the first 6 months and thereafter quarterly until the 2 years after infusion, by flow cytometry and quantitative transgene PCR.
    - Quality of life of included patients, evaluated by a questionnaire completed by patients or their legal guardians at 3 and 6 months and a year after.
    - Toxicity assessment at 3 months and a year after, defined as number of adverse events of any type occurring throughout the study using the common toxicity criteria (version 3.0)
    - Tasa de respuestas (globales y completas) a los 3 meses y al año, definida de manera
    diferente para cada enfermedad.
    o Leucemia linfoide aguda y linfática crónica se emplearán los criterios habituales
    NCCN y IWCLL.
    o Linfoma no-Hodgkin se emplearán los criterios de Lugano.
    o En los pacientes con leucemia se cuantificará la persistencia de enfermedad
    mínima residual en médula ósea y sangre periférica mediante técnicas de
    citometría multiparamétrica y secuenciación de nueva generación.
    - Supervivencia libre de progresión a los 2 años del procedimiento, definida como el
    tiempo transcurrido entre la infusión de ARI-0001 y la progresión de la enfermedad o la
    muerte. Los pacientes vivos y en remisión completa serán censurados en el momento del
    último seguimiento.
    - Supervivencia global (SG) a los 2 años, definida como el tiempo transcurrido entre la
    infusión de ARI-0001 y el fallecimiento del paciente por cualquier causa. Los pacientes
    vivos serán censurados en el momento del último seguimiento.
    - Supervivencia in vivo de las células ARI-0001 en sangre periférica, médula ósea y líquido
    cefalorraquídeo, lo que se determinará mediante citometría de flujo y PCR cuantitativa
    del transgén con periodicidad mensual en los primeros 6 meses y posteriormente
    trimestralmente hasta cumplir 2 años de la infusión.
    - Calidad de vida de los pacientes incluidos, evaluada mediante un cuestionario que
    cumplimentarán los pacientes o sus tutores legales a los 3 y 6 meses y al año.
    - Evaluación de la toxicidad a los 3 meses y al año, definida como número de
    acontecimientos adversos de cualquier tipo ocurridos a lo largo del estudio empleando
    los CTC (common toxicity criteria) versión 3.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    month 3, month 6, 1 year, 2 years and 3 years
    mes 3, mes 6, 1 año, 2 años y 3 años
    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) Yes
    E.7.1.1First administration to humans Yes
    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) 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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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 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
    LVLS
    Última visita 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
    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: 10
    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: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    Expected normal treatment of the condition
    Tratamiento habitual esperado de la enfermedad
    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 Decision2017-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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