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    Summary
    EudraCT Number:2010-020620-22
    Sponsor's Protocol Code Number:L00070IN213P1
    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:2011-02-07
    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 number2010-020620-22
    A.3Full title of the trial
    Estudio en fase II aleatorizado para evaluar la combinación de vinflunina con gemcitabina y vinflunina con carboplatino en pacientes no elegibles para cisplatino con cáncer avanzado o metastásico de células de transición del urotelio

    Randomized phase II study assessing the combination of Vinflunine with Gemcitabine and Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic transitional cell carcinoma of the urothelium
    A.3.2Name or abbreviated title of the trial where available
    JASINT 1
    A.4.1Sponsor's protocol code numberL00070IN213P1
    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 SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 JAVLOR 25 mg/ml concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 INNVINFLUNINA
    D.3.9.3Other descriptive nameVINFLUNINA
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 No
    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 Information not present in EudraCT
    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 namegemcitabine
    D.3.4Pharmaceutical form Powder 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 INNgemcitabine hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgemcitabine hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 No
    D.IMP: 3
    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 Information not present in EudraCT
    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 namecarboplatin
    D.3.4Pharmaceutical form 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 INNcarboplatin
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 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
    Pacientes que no pueden recibir una pauta de tratamiento con cisplatino como quimioterapia de primera línea para el cáncer avanzado o metastásico de células de transición del urotelio (CCTU), en particular los que presentan un aclaramiento de la creatinina < 60 ml/min.
    It concerns patients who cannot receive a cisplatin-based regimen as first line chemotherapy for an advanced or metastatic Transitional Cell Carcinoma of the Urothelium (TCCU), in particular those having a creatinine <60 ml/min.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10046722
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar el índice de control de la enfermedad definido por los criterios de evaluación RECIST [Respuesta completa (RC) + Respuesta parcial (RP) + Enfermedad estable (EE)] para las dos combinaciones de vinflunina + gemcitabina y vinflunina + carboplatino.
    To determine the disease control rate as defined by RECIST assessment criteria [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) rates] for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations
    E.2.2Secondary objectives of the trial
    Evaluar el perfil de seguridad del tratamiento.
    Evaluar otros parámetros de la eficacia: respuesta objetiva (RC + RP), duración de la respuesta y duración de la enfermedad, tiempo hasta el fracaso terapéutico (TFT), supervivencia libre de progresión (SLP) y supervivencia global (SG).

    To assess the safety profile of the treatment.
    To evaluate other efficacy parameters: Objective Response Rate (CR + PR rates), duration of response and duration of disease control, Time to treatment failure (TTF), Progression free survival (PFS) and Overall survival (OS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Hombres o mujeres entre 18 años y < 80 años.
    Consentimiento informado escrito firmado.
    Diagnóstico confirmado histológicamente de cáncer avanzado o metastásico predominantemente de células de transición del urotelio (CCTU) [vejiga urinaria, riñón, pelvis o uréter] .
    Con las siguientes condiciones patológicas:
    - No elegibilidad para el tratamiento con cisplatino debido al menos a una de las dos siguientes circunstancias clínicas:
    . aclaramiento de creatinina estimado (fórmula de Cockroft-Gault) < 60 ml/min,
    . insuficiencia cardiaca congestiva de estado II-III según la Clasificación de la New York Heart ssociation (documentado mediante historia clínica).
    Enfermedad "mensurable" con al menos una lesión unidimensional conforme a las normas RECIST (versión 1.1).
    Estado funcional ECOG de 0 o 1.
    Esperanza de vida estimada de al menos 12 semanas.
    Paciente sin tratamiento antineoplásico sistémico anterior a menos que se haya administrado un CT prequirúrgico o posquirúrgico para el CCTU y si el paciente ha documentado recidiva 6 meses después de la última dosis de CT (antes de autorizarse el CT intravesical).
    Función adecuada del hígado y de la médula ósea demostrada por:
    - recuento absoluto de neutrófilos (RAN) 2000/mm3 ( 2,0 x 109/l)
    -hemoglobina 10 g/dl.,
    -cifra de plaquetas 100.000/mm3,
    -bilirrubina total en suero 1,5x el límite superior de normalidad (LSN),
    -transaminasas 2,5x LSN [ 5x LSN sólo en el caso de metástasis hepática].
    Ausencia de circunstancias psicológicas, familiares, sociológicas o geográficas que impidan potencialmente la observancia del protocolo del estudio y el calendario de seguimiento; estas condiciones deben evaluarse con el paciente antes de registrarse en el estudio.
    Pertenencia del paciente a la Seguridad Social según las leyes locales pertinentes.
    Las mujeres en edad fértil deben utilizar un método anticonceptivo médicamente aceptado para evitar el embarazo durante los 2 meses anteriores al inicio del tratamiento en estudio, durante el periodo del estudio y hasta 3 meses después de la última dosis del tratamiento en estudio; las mujeres en edad fértil deberán obtener un resultado negativo en la prueba del embarazo en suero u orina en las 72 horas anteriores al inicio del tratamiento del estudio.
    Los hombres fértiles deben utilizar un método anticonceptivo durante el estudio y hasta 6 meses después de la última dosis del tratamiento del estudio si sus parejas son mujeres en edad fértil.
    ?Man or woman aged > or = 18 years and < 80 years
    ?Signed written informed consent
    ?Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCCU) [urinary bladder, kidney, renal pelvis, or ureter]
    ?With the following disease conditions :
    Ineligibility for cisplatin-based therapy because of at least one of the following two medical conditions:
    - Calculated creatinine clearance (Cockroft-Gault formula) < 60 mL/min
    - New York Heart Association Classification Stage II-III Congestive Heart Failure (documented by medical history)
    ??Measurable? disease with at least one uni-dimensional lesion according to RECIST guideline (version 1.1)
    ?ECOG performance status of 0 or 1
    ?Estimated life expectancy of at least 12 weeks
    ?Patient without prior systemic anticancer therapy unless if it had been administered as neoadjuvant or adjuvant CT for TCCU and if the patient has documented relapse > or = 6 months after the last dose of CT (prior intravesical CT allowed)
    ?Adequate bone marrow and hepatic functions as evidenced by:
    -Absolute Neutrophil Count ? 2,000/mm3 (? 2.0 x 10^9/L)
    -Haemoglobin ? 10 g/dL
    -Platelet count ?100,000/mm3
    -Serum total bilirubin < or = 1.5 x upper limit of normal (ULN)
    -Transaminases < or = 2.5 x ULN [< or = 5 x ULN only in case of liver metastasis]
    -Absence of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be assessed with the patient before registration in the trial
    ?Patient access to social insurance if applicable in the local regulations
    ?Women of childbearing potential must be using a medically accepted method of contraception to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment; women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment
    ?Fertile men must be using an effective method of birth control during the study and up to 6 months after the last dose of study treatment if their partners are women of childbearing potential.
    E.4Principal exclusion criteria
    Estado funcional ECOG 2.
    Mujeres embarazadas o en periodo de lactancia o con un resultado positivo en la prueba del embarazo en la admisión; mujeres e edad fértil que no utilizaron o no desean o son incapaces de usar un método medicamente aceptado para evitar el embarazo durante los 2 meses anteriores al inicio del tratamiento en estudio, durante el periodo del estudio y hasta 3 meses después de la última dosis del tratamiento en estudio; hombres sexualmente activos que no utilizan un método anticonceptivo durante el estudio y hasta 6 meses después de la última dosis del tratamiento del estudio si su pareja es una mujer en edad fértil.
    Metástasis cerebral conocida o afectación subaracnoidea. (No son necesarias tomografías computerizadas (TC) para descartar esto a menos que exista sospecha clínica de enfermedad del sistema nervioso central (SNC)).
    Neuropatía periférica de grado 2 según NCI CTC [Criterios terminológicos comunes del National Cancer Institute].
    Radioterapia previa en 30% de la médula ósea o finalizada hace < 30 días o sin recuperación total de las toxicidades.
    Otras enfermedades graves o procesos médicos como:
    -Infección que precisa un tratamiento antiinfeccioso sistémico,
    -Cualquier proceso médico que no puede ser controlado, por ejemplo, pacientes con angina inestable, pacientes con infarto de miocardio en los 6 meses anteriores o diabetes no controlada.
    Quimioterapia sistémica anterior por enfermedad avanzada o metastásica o quimioterapia pre-/posquirúrgica que haya finalizado < 6 meses antes de confirmar la progresión.
    Paciente tratado con otro fármaco en investigación o tratamiento antineoplásico en los 30 días antes a la aleatorización.
    Otros cánceres excepto el cáncer basal de piel tratado de forma adecuada, cáncer de cuello uterino in situ o cualquier otro tumor con un intervalo sin enfermedad 5 años.
    Función renal inadecuada definida por un aclaramiento de creatinina en suero < 30 ml/min (fórmula de Cockcroft-Gault).
    Hipersensibilidad conocida a los fármacos del estudio o a fármacos de estructura química similar.
    Pacientes que requieren tratamiento con ketoconazol, itraconazol, ritonavir, amprenavir, indinavir, rifampicina (cualquier inhibidor o inductor potente de CYP3A4) o fenitoína.
    Cualquier inmunoterapia crónica concurrente o aloinjerto orgánico previo.
    Electrocardiograma (ECG) con cambios significativos que indican un riesgo elevado de aparición de un episodio clínico agudo (como signos de angina de pecho o arritmia de alto riesgo...)
    ?ECOG performance status ? 2
    ?Woman if pregnant or lactating or with positive pregnancy test at inclusion; woman of child-bearing potential who did not use or is unwilling or unable to use an acceptable method to avoid pregnancy during the 2 months preceding the start of study treatment, for the entire study period and for up to 3 months after the last dose of study treatment; sexually active fertile man not using effective birth control during the study and up to 6 months after the last dose of study treatment if his partner is a woman of child-bearing potential
    ?Known brain metastasis or leptomeningeal involvement. (Computed Tomography (CT)-scans are not required to rule this out unless there is clinical suspicion of central nervous system (CNS) disease)
    ?Peripheral neuropathy Grade ? 2 by NCI CTC [National Cancer Institute Common Terminology Criteria]
    ?Prior radiation to ?30% of the bone marrow or completed < 30 days ago or without full recovery of toxicities
    ?Other serious illness or medical condition including:
    -Infection requiring systemic anti-infective therapy
    -Any medical condition that might not be controlled, for instance patients with unstable angina, patients with myocardial infarction within 6 months or uncontrolled diabetes
    ?Prior systemic chemotherapy for advanced or metastatic disease or neoadjuvant/adjuvant chemotherapy that was completed < 6 months before documented progression
    ?Patient who had received any other investigational drug or anti-cancer therapy within 30 days before randomisation
    ?Other malignancies except adequately treated basal carcinoma of the skin, in-situ cervix carcinoma or any other tumor with a disease free interval ?5 years
    ?Inadequate renal function defined by a serum creatinine clearance < 30 mL/min (Cockcroft-Gault formula)
    ?Known hypersensitivity to the study drugs or to drugs with similar chemical structures
    ?Patients who require treatment with ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, rifampicine (any potent CYP3A4 inhibitor or inducer) or phenytoine
    ?Any concurrent chronic system immune therapy or previous organ allograft
    ?Electrocardiogram (ECG) with significant modifications suggesting a high risk of occurrence of an acute clinical event (such as signs of angina pectoris or high risk arrhythmia?)
    E.5 End points
    E.5.1Primary end point(s)
    Variables de la eficacia:
    -Se determinarán mediante los criterios RECIST (versión 1.1) del modo siguiente: evaluación de las lesiones (mensurables y no mensurables) en el periodo basal y cada 2 ciclos.
    -Los investigadores evaluarán la progresión y la respuesta tumoral en todos los pacientes aleatorizados.
    -Se evaluará la duración del control de la enfermedad y la respuesta en todos los pacientes con control de la enfermedad y en pacientes que responden, respectivamente.
    -Además, se recogerán parámetros clínicos como intensidad del dolor cada 2 ciclos.

    Variables de seguridad: exploración física y constantes vitales, estado funcional, hemograma, bioquímica sérica, seguridad clínica, acontecimientos adversos usando los Criterios de toxicidad comunes NCI (versión 2.0).
    The primary endpoint is to determine the disease control rate as defined by RECIST assessment criteria [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) rates] for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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 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
    El final del estudio se define como el tiempo a partir de los 30 días después de la última administración del tratamiento del último paciente sometido a tratamiento en el estudio.

    The end of the study is defined as the time from 30 days after the last treatment administration of the last patient under treatment in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 68
    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)
    Vease protocolo.
    See protocol.
    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 Decision2011-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
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