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    Summary
    EudraCT Number:2015-000087-34
    Sponsor's Protocol Code Number:XM22-08
    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:2015-07-31
    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 number2015-000087-34
    A.3Full title of the trial
    An Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Lipegfilgrastim 100 ?g/kg Body Weight in Comparison to Filgrastim 5 ?g/kg Body Weight in Pediatric Patients Diagnosed with Ewing Family of Tumors or Rhabdomyosarcoma Receiving Chemotherapy
    Ensayo abierto, multicéntrico, aleatorizado, controlado con principio activo, para evaluar la eficacia, la farmacocinética, la farmacodinámica, la seguridad, la tolerabilidad y la inmunogenicidad de lipegfilgrastim 100 ?g/kg de peso corporal en comparación con filgrastim 5 ?g/kg de peso corporal en pacientes pediátricos que han sido diagnosticados con la familia de tumores de Ewing o con rabdomiosarcoma y que están recibiendo quimioterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial comparing Lipegfilgrastim to Filgrastim in Pediatric Patients Diagnosed with Ewing Family of Tumors or Rhabdomyosarcoma Receiving Chemotherapy
    Ensayo clínico que compara lipegfilgrastim con filgrastim en pacientes pediátricos diagnosticados con con la familia de tumores de Ewing o con rabdomiosarcoma y que están recibiendo quimioterapia
    A.4.1Sponsor's protocol code numberXM22-08
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/116/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerckle GmbH
    B.1.3.4CountryGermany
    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 supportMerckle GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerckle GmbH
    B.5.2Functional name of contact pointDr. med. Andreas Lammerich
    B.5.3 Address:
    B.5.3.1Street AddressGraf Arco-Strasse 3
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89079
    B.5.3.4CountryGermany
    B.5.4Telephone number+34656577065
    B.5.5Fax number+497314027656
    B.5.6E-mailandreas.lammerich@ratiopharm.de
    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 LONQUEX
    D.2.1.1.2Name of the Marketing Authorisation holderSicor Biotech UAB
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLIPEGFILGRASTIM
    D.3.2Product code XM22
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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 INNLIPEGFILGRASTIM
    D.3.9.1CAS number 1117844-87-7
    D.3.9.2Current sponsor codeXM22
    D.3.9.3Other descriptive nameglyco-PEGylated r-metHuG-CSF
    D.3.9.4EV Substance CodeSUB33778
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Neupogen 30 MU (0.3 mg/ml) solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNeupogen
    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 INNFILGRASTIM
    D.3.9.1CAS number 121181-53-1
    D.3.9.4EV Substance CodeSUB07627MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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
    Neutropenia in pediatric patients diagnosed with Ewing family of Tumors or rhabdomyosarcoma receiving chemotherapy
    Neutropenia en pacientes pediátricos que han sido diagnosticados con la familia de tumores de Ewing o con rabdomiosarcoma y que están recibiendo quimioterapia
    E.1.1.1Medical condition in easily understood language
    Treatment of chemotherapy induced neutropenia (white blood cell decrease)
    Tratamiento de la neutropenia inducida por quimioterapia (disminución de glóbulos blancos)
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10029354
    E.1.2Term Neutropenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10016288
    E.1.2Term Febrile neutropenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy of a single subcutaneous (sc) dose of 100 ?g/kg body weight (BW) of lipegfilgrastim per cycle compared to daily 5 ?g/kg BW of filgrastim doses in children receiving CTX
    El objetivo principal de este estudio consiste en evaluar la eficacia de una única dosis subcutánea (s.c.) de 100 ?g/kg de peso corporal de lipegfilgrastim por ciclo en comparación con dosis diarias de 5 ?g/kg de peso corporal de filgrastim en niños que están recibiendo QT.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess pharmacodynamics, pharmacokinetics, safety, tolerability, and immunogenicity of a single sc dose of 100 ?g/kg BW of lipegfilgrastim per cycle compared to daily doses of 5 ?g/kg BW of filgrastim.
    Los objetivos secundarios de este estudio son evaluar la farmacodinámica, la farmacocinética, la seguridad, la tolerabilidad y la inmunogenicidad de una única dosis s.c. de 100 µg/kg de peso corporal de lipegfilgrastim por ciclo en comparación con dosis diarias de 5 µg/kg de peso corporal de filgrastim.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Male or female children and adolescents aged 2 to <18 years at screening.
    b) Written informed consent provided by parent(s)/legal representative(s) of the pediatric patient and patients assent if appropriate, before screening procedures are initiated.
    c) Able to understand and/or follow study instructions alone or with parental assistance.
    d) Diagnosed with the Ewing family of tumors, or rhabdomyosarcoma.
    e) Scheduled to receive 1 of the following CTX regimens (inpatient or outpatient):
    For the Ewing Family of Tumors:
    - VIDE; with concomitant sodium 2-mercaptoethane sulfonate (MESNA)
    according to local standards.
    - VDC/IE; with concomitant MESNA treatment according to local standards.
    For Rhabdomyosarcoma:
    - VAC; with concomitant MESNA treatment according to local standards.
    - VDC/IE; with concomitant MESNA treatment according to local standards.
    - IVA; with concomitant MESNA treatment according to local standards.
    f) Minimum BW 12.5 kg.
    g) Life expectancy of at least 3 months with appropriate therapy
    h) WBC count >2.5 × 109/L, ANC >=1.5 ×10^9/L, and platelet count >=100 × 10^9/L (at screening and prior to CTX)
    i) For patients aged >=12 years, Eastern Cooperative Oncology Group (ECOG) performance status =<2.
    j) Fertile patients (male or female) must use highly reliable contraceptive measures (ie, 2 of the following: oral contraception, implants, injections, barrier contraception, and intrauterine device, or vasectomized/sterilized partners, or sexual abstinence) for the entire duration of the study. For purposes of this study, a fertile female patient is any female patient who has experienced menarche and who has not undergone tubal ligation.
    k) Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit.
    a) Niños y adolescentes de ambos sexos de edades comprendidas entre 2 y <18 años en el momento de la selección.
    b) Consentimiento informado por escrito proporcionado por el padre o madre o representante legal del paciente pediátrico y el asentimiento del paciente si se considera apropiado, antes de iniciar los procedimientos de selección.
    c) Capaz de comprender o de seguir las instrucciones del estudio solo o con ayuda de los padres.
    d) Diagnóstico de familia de tumores de Ewing o rabdomiosarcoma.
    e) En lista para recibir 1 de los siguientes regímenes de QT (hospitalario o ambulatorio):
    Para la familia de tumores de Ewing:
    - Vincristina/Ifosfamida/Doxorrubicina/Etopósido (VIDE); con sodio 2-mercaptoetanosulfonato concomitante (MESNA) de acuerdo con los estándares locales.
    - Vincristina/Doxorrubicina/Ciclofosfamida en alternancia con Ifosfamida/Etopósido (VDC/IE); con tratamiento concomitante de MESNA de acuerdo con los estándares locales.
    Para rabdomiosarcoma:
    - Vincristina/Actinomicina/Ciclofosfamida (VAC); con tratamiento concomitante de MESNA de acuerdo con los estándares locales.
    - VDC/IE; con tratamiento concomitante de MESNA de acuerdo con los estándares locales.
    - Ifosfamida, Vincristina y Actinomicina D (IVA); con tratamiento concomitante de MESNA de acuerdo con los estándares locales.
    f) Peso corporal mínimo 12,5 kg.
    g) Esperanza de vida de 3 meses como mínimo con tratamiento adecuado.
    h) Recuento de leucocitos >2,5 × 10^9/L, recuento absoluto de neutrófilos (RAN)>= 1,5 × 10^9/L y recuento plaquetario >=100 × 109/L (en la selección y antes de la QT).
    i) En pacientes de >=12 años, estado funcional del Eastern Cooperative Oncology Group (ECOG) =<2.
    j) Los pacientes fértiles (varones o mujeres) deberán utilizar métodos anticonceptivos muy eficaces (por ej. 2 de los siguientes: anticoncepción oral, implantes, inyecciones, anticoncepción de barrera y dispositivo intrauterino, o parejas vasectomizadas o esterilizadas, o abstinencia sexual) durante toda la duración del estudio. A los efectos de este estudio, una paciente fértil es cualquier paciente de sexo femenino que ha experimentado menarquia y que no se ha sometido a una ligadura de trompas.
    k) Las pacientes que han llegado a la menarquia deberán obtener un resultado negativo en el test de embarazo en orina en la visita de selección.
    E.4Principal exclusion criteria
    a. Previous exposure to filgrastim, pegfilgrastim, lenograstim or other granulocyte colony stimulating factors (G-CSFs) / granulocyte macrophage colony-stimulating factors (GM-CSFs) in clinical development within 6 weeks prior to the first lipegfilgrastim/filgrastim
    administration in this study.
    b. Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim, any other G-CSF in clinical development or any LONQUEX (lipegfilgrastim) excipients.
    c. History of congenital neutropenia or cyclic neutropenia.
    d. Patients with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, electrocardiogram (ECG), laboratory tests, or imaging.
    e. Pregnancy or breast feeding (if a patient becomes pregnant during the study she will be withdrawn from the study).
    f. Prior bone marrow or stem cell transplant, or prior radiation to >= 25% of bone marrow (eg, whole pelvic radiation) for any reason, or any therapeutic radiation within the 3 weeks prior to the first dose of study drug (lipegfilgrastim/filgrastim).
    g. Major surgery or serious infection within 3weeks before first administration of study drug (lipegfilgrastim/filgrastim), serious trauma or compound medical procedure within the 4 weeks prior to the first study drug dose.
    h. Treatment with lithium at screening or planned during the study.
    i. Participation in a clinical study within 30 days before randomization.
    a) Exposición previa a filgrastim, pegfilgrastim, lenograstim u otros factores estimuladores de colonias de granulocitos (GCSF) / factores estimuladores de colonias degranulocitos y macrófagos (GMCSF) en desarrollo clínico durante las 6 semanas previas a la primera administración de lipegfilgrastim/filgrastim en este estudio.
    b) Hipersensibilidad conocida a filgrastim, pegfilgrastim, lenograstim, a cualquier otro GCSF en desarrollo clínico o a cualquiera de los excipientes de LONQUEX (lipegfilgrastim).
    c) Antecedentes de neutropenia congénita o neutropenia cíclica.
    d) Pacientes con una situación médicamente importante o inestable o quirúrgica que descarte una participación en el estudio completa y segura, tal y como lo determinan la historia clínica, las exploraciones físicas, el electrocardiograma (ECG), las pruebas de laboratorio o las pruebas de imagen.
    e) Embarazo o lactancia (si una paciente se queda embarazada durante el estudio, será retirada del estudio).
    f) Trasplante previo de médula ósea o de células madre, o radiación previa de >=25% de la médula ósea (por ej. radiación completa de la pelvis) por cualquier motivo, o radiación terapéutica durante las 3 semanas previas a la primera dosis del fármaco del estudio (lipegfilgrastim/filgrastim).
    g) Cirugía mayor o infección grave durante las 3 semanas antes de la primera administración del fármaco del estudio (lipegfilgrastim/filgrastim), traumatismo grave o procedimiento médico complicado durante las 4 semanas previas a la primera dosis del fármaco del estudio.
    h) Tratamiento con litio en la selección o previsión de tratamiento durante el estudio.
    i) Participación en un ensayo clínico durante los 30 días anteriores a la aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the duration of severe neutropenia (DSN) in cycle 1, defined as the number of days with severe neutropenia in cycle 1 (from start of CTX until day 15). Severe neutropenia is defined as grade 4 neutropenia, with ANC <0.5 × 10^9/L.
    El criterio de valoración principal de la eficacia es la duración de la neutropenia grave (DNG) en el ciclo 1, que se define como el número de días con neutropenia grave en el ciclo 1 (desde el inicio de la QT hasta el día 15). La neutropenia grave se define como neutropenia de grado 4, con RAN <0,5 ×10^9/L.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Samples for ANC assessments in cycles 1 to 4 will be obtained on day 1 prior to study drug administration, on days 2, 4, 5, 6, 7, 8, 9, 10, 12, and 15 and at EOS/(or ET) visit.
    Las muestras para las evaluaciones de RAN en los ciclos 1 a 4 se obtendrán el día 1 antes de la administración del fármaco del estudio, en los días 2, 4, 5, 6, 7, 8, 9, 10, 12, y 15 y en la visita final del ensayo / o visita de finalización prematura.
    E.5.2Secondary end point(s)
    Secondary Efficacy Variables and Endpoints:
    The secondary efficacy endpoints for this study are as follows:
    - Incidence of severe neutropenia (ANC <0.5 × 10^9/L) in each cycle (1- 4).
    - Incidence of very severe neutropenia (ANC <0.1 × 10^9/L) in each cycle (1-4).
    - Incidence of febrile neutropenia (FN) (defined as body temperature >38.3°C or 2 consecutive readings higher than 37.8°C measured at axilla or external ear for 2 hours and ANC <0.5 × 10^9/L or expected to fall below 0.5 × 10^9/L) per cycle and across all cycles.
    - DSN in cycles 2-4 per cycle.
    - Duration of very severe neutropenia in cycles 1-4 per cycle.
    Efficacy evaluations will be performed on blood samples taken for the pharmacodynamic assessments in combination with temperature measurements.
    Secondary Pharmacodynamic Variables and Endpoints:
    - Area under the curve of ANC (AUCANC) until day 15 in cycle 1.
    - ANC nadir, ie, the lowest ANC value recorded, per cycle.
    - Time to ANC nadir per cycle, defined as the time from start of CTX until occurrence of the ANC nadir in the cycle.
    - Time to ANC nadir per cycle, defined as the time from first study drug administration in a cycle until occurrence of the ANC nadir in the cycle.
    - Time to ANC recovery (ANC >1.0 × 10^9/L and ANC >2.0 × 10^9/L) from first day of CTX.
    - Time to ANC recovery (ANC >1.0 × 10^9/L and ANC >2.0 × 10^9/L) from nadir per cycle.
    Variables y criterios de valoración secundarios de la eficacia:
    - Incidencia de neutropenia grave (RAN <0,5 × 10^9/L) en cada ciclo (1 4).
    - Incidencia de neutropenia muy grave (RAN <0,1 × 10^9/L) en cada ciclo (1 4).
    - Incidencia de neutropenia febril (NF) (definida como temperatura corporal >38,3°C o 2 lecturas consecutivas superiores a 37,8°C medidas en la axila u oído externo durante 2 horas y RAN <0,5 × 10^9/L o previsión de descenso por debajo de 0,5 ×10^9/L) por ciclo y a lo largo de todos los ciclos.
    - DNG en ciclos 24 por ciclo.
    - Duración de la neutropenia muy grave en ciclos 14 por ciclo.
    Las evaluaciones de la eficacia se realizarán en muestras de sangre obtenidas para las evaluaciones farmacodinámicas en combinación con las mediciones de la temperatura.
    Variables y criterios de valoración secundarios farmacodinámicos:
    - Área bajo la curva de RAN (ABCRAN) hasta el día 15 del ciclo 1.
    - Nadir del RAN, es decir, el valor mínimo del RAN registrado, por ciclo.
    - Tiempo hasta el nadir del RAN por ciclo, definido como el tiempo desde el inicio de la QT hasta la aparición del nadir del RAN en el ciclo.
    - Tiempo hasta el nadir del RAN por ciclo, definido como el tiempo desde la primera administración del fármaco del estudio en un ciclo hasta la aparición del nadir del RAN en el ciclo.
    - Tiempo hasta la recuperación del RAN (RAN >1,0 × 10^9/L y RAN >2,0 × 10^9/L) desde el primer día de QT.
    - Tiempo hasta la recuperación del RAN (RAN >1,0 × 10^9/L y RAN >2,0 × 10^9/L) desde el nadir por ciclo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Samples for PD assessments (ANC) in cycles 1 to 4 will be obtained on day 1 prior to study drug administration, on days 2, 4, 5, 6, 7, 8, 9, 10, 12, and 15 and at EOS/(or ET) visit.
    Continous tempareture measurements during the days 1-21 of each cycle.
    Las muestras para las evaluaciones de farmacodinamia (RAN) en los ciclos 1 a 4 se obtendrán el día 1 antes de la administración del fármaco del estudio, en los días 2, 4, 5, 6, 7, 8, 9, 10, 12, y 15 y en la visita final del ensayo / o visita de finalización prematura.
    Mediciones continuas de Tempareture durante los días 1-21 de cada ciclo
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic 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 Yes
    E.6.13.1Other scope of the trial description
    tolerability, immunogenicity
    tolerabilidad, inmunogenicidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Bulgaria
    Czech Republic
    Germany
    Hungary
    Lithuania
    Poland
    Romania
    Russian Federation
    Slovakia
    Spain
    Ukraine
    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 del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 42
    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: 28
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 14
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 42
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-08
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