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    Summary
    EudraCT Number:2007-005017-19
    Sponsor's Protocol Code Number:BO20924
    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:2009-10-21
    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 number2007-005017-19
    A.3Full title of the trial
    Estudio abierto, multicéntrico y aleatorizado en fase II para evaluar la adición de bevacizumab a la quimioterapia en niños y adolescentes con diganóstico inicial de sarcoma metastásico de tejidos blandos, rabdomiosarcoma y no-rabdomiosarcoma.
    Open-label, multi-center, randomized, phase II study evaluating the addition of bevacizumab to chemotherapy in childhood and adolescent patients presenting with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.
    A.4.1Sponsor's protocol code numberBO20924
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 AVASTIN 25 mg/ml concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNBEVACIZUMAB
    D.3.9.3Other descriptive nameBEVACIZUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal humanizado recombinante
    D.IMP: 2
    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 AVASTIN 25 mg/ml concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNBEVACIZUMAB
    D.3.9.3Other descriptive nameBEVACIZUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal humanizado recombinante
    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
    Tratamiento primario de niños y adolescentes con diagnóstico inicial de sarcoma metastásico de tejidos blandos, rabdomiosarcoma (RMS) y no-rabdomiosarcoma (NRMS).
    Primary treatment of newly diagnosed childhood and adolescent metastatic rhabdomyosarcoma (RMS) and non-rhabdomyosarcoma soft tissue sarcoma (NRSTS).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10042864
    E.1.2Term Synovial sarcoma metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10016635
    E.1.2Term Fibrosarcoma metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029274
    E.1.2Term Neurofibrosarcoma metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10024629
    E.1.2Term Liposarcoma metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10060651
    E.1.2Term Malignant hemangiopericytoma metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039026
    E.1.2Term Rhabdomyosarcoma previously untreated
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065868
    E.1.2Term Embryonal rhabdomyosarcoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065867
    E.1.2Term Alveolar rhabdomyosarcoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039024
    E.1.2Term Rhabdomyosarcoma NOS
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039022
    E.1.2Term Rhabdomyosarcoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10016632
    E.1.2Term Fibrosarcoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039494
    E.1.2Term Sarcoma NOS
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10058387
    E.1.2Term Schwannoma malignant
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061526
    E.1.2Term Malignant mesenchymoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10024189
    E.1.2Term Leiomyosarcoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10015099
    E.1.2Term Epithelioid sarcoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064581
    E.1.2Term Desmoplastic small round cell tumour
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001882
    E.1.2Term Alveolar soft part sarcoma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia de la adición de bevacizumab a la quimioterapia en comparación con la quimioterapia aislada en niños y adolescentes que presentan RMS y SPBDR metastásicos determinado mediante la supervivencia sin episodios (SSE).
    E.2.2Secondary objectives of the trial
    Determinar la seguridad, tolerabilidad y eficacia de la adición de bevacizumab a la quimioterapia en comparación con la quimioterapia aislada en pacientes que presentan RMS y SPBDR metastásicos evaluadas mediante:
    Perfil de acontecimientos adversos.
    Interrupción, modificación o retraso de cualquier componente del tratamiento.
    Tasa de respuesta global (según los criterios RECIST) antes del tratamiento local.
    Supervivencia global (SG).
    Duración de la respuesta (DR).
    Caracterizar el perfil farmacocinético de bevacizumab en todos los subgrupos de edad de la población del estudio.
    Correlación de las evaluaciones de biomarcadores con factores de riesgo y el resultado del tratamiento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1.Banco de muestras (BO20924RG,12Dec2008) : obtener una muestra de sangre para efectuar un análisis de investigación farmacogenética y genética de los pacientes que que otorguen su consentimiento/asentimiento y que fueron aleatorizados en el estudio asociado.
    2. Banco de muestras para análisis de biomarcadores (dentro protocolo prinicipal)
    E.3Principal inclusion criteria
    1.Deberá obtenerse el consentimiento informado por escrito del paciente, sus padres o su representante legal (última versión aprobada por el comité ético de investigación clínica [CEIC]) antes de llevar a cabo ninguna de las evaluaciones y procedimientos específicos del estudio.
    2.Edad &#8805; 6 meses y < 18 años.
    3.El paciente debe haber presentado un diagnóstico inicial de sarcoma metastásico de tejidos blandos y un diagnóstico confirmado histológicamente de rabdomiosarcoma o no-rabdomiosarcoma;
    el tumor primario puede estar intacto u oculto o haber sido extirpado de manera total o subtotal.
    los pacientes que se hayan sometido a cirugía antes de incorporarse al estudio no deberán ser aleatorizados antes de haber transcurrido 4 semanas después de la operación y sólo cuando la herida haya cicatrizado satisfactoriamente.
    4.Según el criterio clínico del médico responsable del tratamiento, el paciente debe tener una condición física suficiente como para recibir tratamiento en el contexto del ensayo.
    5.Función de la médula ósea adecuada:
    Recuento absoluto de neutrófilos (RAN) &#8805; 1,0 x 109/l
    Recuento de leucocitos &#8805; 2,0 x 109/l
    Recuento de plaquetas &#8805; 100 x 109/l
    (en caso de afectación de la médula ósea &#8805; 75 x 109/l)
    Hb > 7,5 g/dl (75 g/l, incluso después de una transfusión).
    6.Coagulación de la sangre adecuada:
    Los pacientes no tratados con anticoagulantes deben tener un INR &#61603; 1,5 y un TTPa &#61603; 1,5 veces el LSN.
    Se permite la anticoagulación con la condición de que el INR esté dentro del intervalo terapéutico y de que el TTPa esté dentro de un intervalo terapéutico estable de entre 1,5 y 2,5 veces el LSN en los pacientes que reciben una dosis terapéutica de un cumarínico y una heparina no fraccionada, respectivamente.
    7.Función hepática adecuada:
    Bilirrubina total &#61603; 1,5 veces el LSN.
    AST y ALT &#8804; 2,5 veces el LSN en los pacientes sin metástasis hepáticas y &#8804; 5 veces el LSN en los pacientes con metástasis hepáticas.
    8.Función renal adecuada:
    Concentración sérica de creatinina &#8804; 1,5 veces el LSN para la edad.
    Si la creatinina sérica es > 1,5 veces el LSN para la edad, la FG estimada, o la FG formal, debe ser > 90 ml/min/1,73 m2.
    Ausencia de proteinuria clínicamente significativa
    Un análisis de orina con tira reactiva a primera hora de la mañana de selección (primera muestra) debe ser < 2+
    Si el análisis de orina con tira reactiva muestra una proteinuria &#8805; 2+, el cociente entre albúmina y creatinina (Alb/Cr) en la orina de primera hora de la mañana debe ser < 30 mg/mmol, el cociente entre proteínas y creatinina (Pr/Cr) debe ser < 50 mg/mmol o la excreción de proteínas en orina de 24 horas debe ser < 0,5
    9.La función ventricular izquierda determinada mediante la fracción de acortamiento (FA) y evaluada mediante un ecocardiograma 2D está por encima del límite inferior de la normalidad en los grupos de edad siguientes:
    6 meses - < 3 años: FA &#8805; 35%
    &#8805; 3 años FA &#8805; 28%
    E.4Principal exclusion criteria
    1.Tumores malignos previos.
    2.Tratamiento antitumoral sistémico previo.
    3.Signos clínicos de afectación del SNC o compresión de la médula espinal confirmada radiológicamente.
    4.Signos radiológicos de invasión tumoral de la pared de un vaso sanguíneo importante.
    5.Intervención de cirugía mayor, biopsia abierta o lesión traumática importante en los 28 días anteriores a la aleatorización o previsión de la necesidad de una intervención de cirugía mayor (programada) durante el tratamiento del estudio. Intervenciones de cirugía menor en los 2 días anteriores a la aleatorización (incluida la colocación de un DAVC).
    6.Herida quirúrgica o fractura ósea que no ha curado satisfactoriamente o presencia de una úlcera péptica activa.
    7.Tratamiento actual o reciente (en los 30 días anteriores al inicio del estudio) con otro fármaco en investigación o participación en otro estudio de investigación.
    8.Aumento del riesgo de trastornos hemorrágicos digestivos, renales, medulares o congénitos.
    9.Antecedentes o signos de una enfermedad intercurrente aguda no controlada al incorporarse al estudio, por ejemplo,
    Crisis convulsivas no controladas.
    Diátesis de la coagulación hemorrágica de cualquier tipo.
    Enfermedades cardiovasculares clínicamente importantes (es decir, activas), por ejemplo, accidentes cerebrovasculares (ACV)/ictus, infarto de miocardio (IM), accidentes isquémicos transitorios (AIT), angina de pecho inestable o arritmia cardíaca aguda; signos clínicos de hipertensión arterial, especificada como una PA sistólica y diastólica &#8805; percentil 95 para la edad, el sexo y la talla.
    Cualquier otra enfermedad, disfunción metabólica o psicológica, signos en la exploración física o resultados analíticos que ofrezcan sospechas razonables de una enfermedad o trastorno que contraindique el uso de un fármaco en investigación o que conlleve un riesgo inaceptable para el paciente de sufrir complicaciones por el tratamiento.
    Neuropatía general o periférica de grado &#8805; 2 no debida a la neoplasia maligna subyacente.
    Infección no controlada.
    10.Hipersensibilidad conocida a
    Alguno de los componentes de los fármacos del estudio.
    Productos derivados de ovarios de hámster chino u otros anticuerpos humanizados o humanos recombinantes.
    11.Tratamiento diario crónico con ácido acetilsalicílico (> 325 mg/día) o clopidogrel (> 75 mg/día).
    12.Mujeres embarazadas o lactantesToda mujer que haya tenido la menarquia y los varones que no estén dispuestos a utilizar un método anticonceptivo eficaz (como implantes, inyectables, anticonceptivos orales combinados, dispositivos intrauterinos (DIU) o método de barrera junto con gel espermicida)Incapacidad del paciente de cumplir el protocolo.
    13.Incapacidad del paciente de cumplir el seguimiento a largo plazo en el centro de investigación.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal del estudio es la duración de la supervivencia sin episodios (SSE). La SSE se define como el tiempo transcurrido entre la aleatorización y la progresión de la enfermedad, recidiva, respuesta terapéutica insuficiente después de 3 ciclos de quimioterapia de inducción, segundo cáncer primario o muerte por cualquier causa. A los pacientes que no presenten ningún episodio se les censurará en la última visita de seguimiento de la progresión. A los que no dispongan de ningún seguimiento posbasal de la progresión se les censurará el día de la aleatorización.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability; Biomarker assessment
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El final del estudio será la fecha de la visita clínica final programada del último paciente para completar el estudio o la fecha en que se hayan recibido los últimos datos del último paciente, que se necesitan para el análisis de la supervivencia global, lo que suceda más tarde.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Menores
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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 Decision2009-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-30
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