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    Summary
    EudraCT Number:2011-001012-56
    Sponsor's Protocol Code Number:I3X-MC-JHTB
    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:2012-06-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-001012-56
    A.3Full title of the trial
    A Phase 2 Study of LY2784544 in Patients with
    Myeloproliferative Neoplasms
    Estudio de fase 2 de LY2784544 en pacientes con
    neoplasias mieloproliferativas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with Myeloproliferative Neoplasms
    Estudio en Neoplasias Mieloproliferativas.
    A.4.1Sponsor's protocol code numberI3X-MC-JHTB
    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 SponsorLilly S.A
    B.1.3.4CountrySpain
    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 supportLilly S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLilly
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressAvda de la Industria30
    B.5.3.2Town/ cityAlcobendas Madrid
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number34916633485
    B.5.5Fax number34916633481
    B.5.6E-mailjulian_inmaculada@lilly.com
    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.3.2Product code LY2784544
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLY2784544
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeLY2784544
    D.3.9.3Other descriptive nameJAK 2 Inhibitor
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 600
    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) 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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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.2.1.2Country 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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 315-30-0
    D.3.9.3Other descriptive nameALLOPURINOL
    D.3.9.4EV Substance CodeSUB05338MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 300
    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) 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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myeloproliferative Neoplasms
    Neoplasias mieloproliferativas
    E.1.1.1Medical condition in easily understood language
    Myeloproliferative Neoplasms
    Neoplasias mieloproliferativas
    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 14.1
    E.1.2Level HLT
    E.1.2Classification code 10028578
    E.1.2Term Myeloproliferative disorders (excl leukaemias)
    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 the study is to assess the activity of LY2784544 therapy administered once daily, as measured by objective response rate, in patients with the myeloproliferative neoplasms: PV, ET, and MF.
    El objetivo principal del estudio es evaluar la actividad del tratamiento con LY2784544
    administrado una vez al día, según lo determinado mediante la tasa de respuesta objetiva, en pacientes con neoplasias mieloproliferativas: PV, TI y MF.
    E.2.2Secondary objectives of the trial
    to characterize the safety and toxicity profile of LY2784544 by MPN subtype
    ? to assess the individual components of response criteria including changes in
    spleen and liver measurement, changes in JAK2 V617F mutant allele burden,
    changes in blood counts, changes in bone marrow histology, and changes in
    transfusion or phlebotomy requirements by MPN subtype
    ? to document any change in patient-reported or physician assessment of symptom
    burden by MPN subtype
    ? to estimate the PK parameters of LY2784544 by dose and explore for potential
    relationship with response for each MPN subtype
    ? to document any change in frequency of thrombotic/hemorrhagic events after
    treatment with LY2784544 by MPN subtype
    ? to assess time-to-event measures, including time to best response and duration of
    response for each MPN subtype
    ? to describe response to LY2784544 in patients with wild-type JAK2
    Caracterizar el perfil de seguridad y toxicidad de LY2784544 en función del
    subtipo de NMP.
    ? Evaluar los componentes individuales de los criterios de respuesta, en la carga del alelo
    mutante V617F de JAK2, en el hemograma, en la histología de la médula ósea y
    en los requisitos de transfusión o flebotomía en función del subtipo de NMP.
    ? Documentar cualquier variación en la evaluación realizada por el paciente o el
    médico de la carga de los síntomas en función del subtipo de NMP.
    ? Calcular los parámetros FC de LY2784544 según la dosis y explorar la relación
    potencial con la respuesta en cada subtipo de NMP.
    ? Documentar cualquier variación en la frecuencia de episodios trombóticos/hemorrágicos después del tratamiento con LY2784544 en función del subtipo de NMP.
    ? Evaluar los criterios de tiempo hasta el acontecimiento para cada subtipo de NMP.
    ? Describir la respuesta a LY2784544 en pacientes con JAK2 de tipo natural.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Have a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET),
    or myelofibrosis (MF) as defined by the World Health Organization (WHO)
    diagnostic criteria for myeloproliferative neoplasms (Swerdlow et al. 2008)
    and meet the following additional subtype specific criteria:
    A. PV:
    i. have failed or is intolerant of standard therapies or refuses to take
    standard medications.
    B. ET:
    i. have failed or is intolerant of standard therapies or refuses to take
    standard medications.
    C. MF (patients with MF must meet at least 1 of the following):
    i. have intermediate 1, intermediate 2, or high-risk MF according to
    the Dynamic International Prognostic Scoring System (DIPPS
    Plus) for Primary Myelofibrosis (Gangat et al. 2011); or
    ii. have symptomatic MF with spleen greater than 10 cm below left
    costal margin; or
    iii. have post-polycythemic MF; or
    iv. have post-ET MF
    All PV, ET, and MF patients must meet the following criteria:
    [2] Have a quantifiable JAK2 V617F mutation. For patients in Dose Level 3, this
    inclusion criterion will not apply to the subset of patients in Cohorts 10 and 11
    that are required to be negative for the JAK2 V617F mutation. This subset of
    patients must be negative for the mutation with unquantifiable levels of JAK2
    V617F.
    [3] Are ?18 years of age.
    [4] Have given written informed consent prior to any study-specific procedures.
    [5] Have adequate organ function, including:
    Hepatic: Bilirubin ?1.5 times upper limits of normal (ULN), alanine
    transaminase (ALT), and aspartate transaminase (AST) ?2.5 times ULN.
    Renal: Serum creatinine ?1.5 times ULN.
    Bone Marrow Reserve: Absolute neutrophil count (ANC) ?1000/mcL,
    platelets ?50,000 /mcL for patients with ET or PV and ?25,000 /mcL for
    patients with MF.
    [6] Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology
    Group (ECOG) scale (refer to Attachment 4).
    [7] Have discontinued all previous approved therapies for MPNs, including any
    chemotherapy, immunomodulating therapy (for example, thalidomide,
    interferon-alpha), immunosuppressive therapy (for example, corticosteroids
    >10 mg/day prednisone or equivalent), radiotherapy, and erythropoietin,
    thrombopoietin, or granulocyte colony stimulating factor for at least 14 days
    and recovered from the acute effects of therapy. Hydroxyurea used to control
    blood cell counts is permitted at study entry if the subject has been maintained
    on a stable dose for at least 4 weeks. Low-dose acetylsalicylic acid (aspirin)
    is permitted as well.
    [8] Are reliable and willing to make themselves available for the duration of the
    study and are willing to follow study procedures.
    [9] Males and females with reproductive potential must agree to use medically
    approved contraceptive precautions during the study and for 3 months
    following the last dose of study drug.
    [10] Females with child-bearing potential must have had a negative urine
    pregnancy test ?7 days before the first dose of study drug and must also not be
    breastfeeding.
    [11] Are able to swallow capsules.
    [12] For patients who have undergone recent major surgery, at least 28 days must
    have elapsed between surgery and study participation and the subject must
    have achieved, in the opinion of the treating physician, at least a good
    recovery from the surgical procedure
    [1] Tener un diagnóstico de policitemia vera (PV), trombocitemia idiopática (TI)
    o mielofibrosis (MF), según la definición de los criterios diagnósticos de la
    Organización Mundial de la Salud (OMS) para las neoplasias
    mieloproliferativas (Swerdlow y cols. 2008) y cumplir los criterios específicos
    del subtipo adicionales siguientes:
    A. PV:
    i. haber experimentado un fracaso con los tratamientos de referencia,
    presentar intolerancia o negarse a tomar la medicación de
    referencia.
    B. TI:
    i. haber experimentado un fracaso con los tratamientos de referencia,
    presentar intolerancia o negarse a tomar la medicación de
    referencia.
    C. MF (los pacientes con MF deben cumplir como mínimo 1 de los siguientes):
    i. padecer MF de riesgo intermedio 1, intermedio 2 o elevado según
    el sistema internacional de puntuación pronóstica (DIPPS Plus)
    para la mielofibrosis primaria (Gangat y cols. 2011); o
    ii. presentar MF sintomático con tamaño del bazo superior a 10 cm
    por debajo del margen costal izquierdo; o
    iii. presentar MF posterior a policitemia; o
    iv. presentar MF posterior a TI
    Todos los pacientes con PV, TI y MF deben cumplir los criterios siguientes:
    [2] Presentar una mutación V617F de JAK2 cuantificable. En el caso de los
    pacientes del nivel de dosis 3, este criterio de inclusión no se aplicará al
    subconjunto de pacientes de las cohortes 10 y 11, que deben presentar
    negatividad para la mutación V617F de JAK2. Este subconjunto de pacientes
    debe presentar negatividad para la mutación con niveles no cuantificables de
    V617F de JAK2.
    [3] Tener ??18 años de edad.
    [4] Haber otorgado el consentimiento informado por escrito antes de realizar
    cualquiera de los procedimientos específicos del estudio.
    [5] Tener una función orgánica suficiente, que incluye:
    Hepática: bilirrubina ??1,5 veces el límite superior de la normalidad (LSN),
    alanina transaminasa (ALT) y aspartato transaminasa (AST) ??2,5 veces el
    LSN.
    Renal: Creatinina sérica ??1,5 veces el LSN.
    Reserva medular: recuento absoluto de neutrófilos (RAN) A 1.000/mcl,
    plaquetas A 50.000/mcl para los pacientes con TI o PV y A 25.000/mcl para
    los pacientes con MF.
    [6] Presentar un estado funcional de 0, 1 ó 2 en la escala del Eastern Cooperative
    Oncology Group (ECOG) (consúltese el Anexo 4).
    [7] Haber suspendido todos los tratamientos autorizados previos para la NMP,
    incluidos quimioterapia, tratamiento inmunomodulador (por ejemplo,
    talidomida, interferón-R), tratamiento inmunodepresor (por ejemplo,
    corticoesteroides > 10 mg/día de prednisona o equivalente), radioterapia y
    eritropoyetina, trombopoyetina o factor estimulante de colonias de
    granulocitos durante al menos 14 días y haberse recuperado de los efectos
    agudos del tratamiento. Se permite el uso de hidroxiurea para el control del
    recuento de las células sanguíneas en el momento de inclusión en el estudio en
    caso de que el paciente haya mantenido una dosis estable durante al menos
    4 semanas. Se permitirá también el uso de ácido acetilsalicílico (aspirina) en
    dosis bajas.
    [8] Ser fiable y estar dispuesto a encontrarse disponible durante todo el estudio y
    mostrarse dispuesto a seguir los procedimientos del estudio.
    [9] Los pacientes de ambos sexos en edad fértil deben comprometerse a utilizar
    métodos anticonceptivos médicamente aprobados durante el estudio y durante
    3 meses después de la última dosis de medicamento del estudio.
    [10] Las mujeres en edad fértil deberán presentar una prueba de embarazo en orina
    negativa ??7 días antes de la primera administración del medicamento del
    estudio y no deberán encontrarse en período de lactancia.
    [11] Ser capaz de ingerir cápsulas.
    [12] En el caso de los pacientes que se han sometido a cirugía mayor reciente,
    deberán haber transcurrido al menos 28 días entre la cirugía y la participación
    en el estudio y el paciente deberá haber alcanzado, a criterio del médico
    responsable del tratamiento, como mínimo una recuperación favorable de la
    intervención quirúrgica.
    E.4Principal exclusion criteria
    [13] Are currently enrolled in, or discontinued within the last 14 days from a
    clinical trial involving an investigational product or non-approved use of a
    drug or device, or concurrently enrolled in any other type of medical research
    judged not to be scientifically or medically compatible with this study.
    [14] Have a corrected QT (QTc) interval >470 msec using Bazett's formula.
    [15] Have serious preexisting medical conditions that, in the opinion of the
    investigator would preclude participation in the study (for example a
    gastrointestinal disorder causing clinically significant symptoms such as
    nausea, vomiting, and diarrhea, or malabsorption syndrome).
    [16] Are currently being treated with agents that are metabolized by CYP3A4 with
    a narrow therapeutic margin (for example, alfentanil, cyclosporine,
    diergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and
    tacrolimus) or CYP2B6 (for example, cyclophosphamide, ifosfamide,
    tamoxifen, efavirenz, propofol, methadone, and bupropion).
    [17] Are currently being treated with warfarin or 1 of its derivatives which is
    known to alter levels of protein C or protein S. An exception to this criterion
    will be allowed for patients with a prior history of Budd-Chiari Syndrome
    who are being treated with warfarin or 1 of its derivatives.
    [18] Have received a hematopoietic stem cell transplant.
    [19] Have a second primary malignancy that in the judgment of the Investigator
    and Sponsor may affect the interpretation of results.
    [20] Have an active fungal, bacterial, and/or known viral infection including
    human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis
    (screening is not required).
    [21] Have a history of congestive heart failure with New York Heart Association
    Class >2 (NYHA Class 1 and 2 are eligible), unstable angina, recent
    myocardial infarction (within 6 months prior to administration of study drug),
    or documented history of ventricular arrhythmia.
    [13] Estar incluido en la actualidad, o haberse retirado en los 14 días precedentes,
    en un ensayo clínico sobre un producto en investigación o sobre el uso no
    autorizado de un medicamento o dispositivo o estar incluido de forma
    simultánea en algún otro tipo de investigación médica que no se considere
    científica o médicamente compatible con este estudio.
    [14] Tener un intervalo QT corregido (QTc) > 470 ms según la fórmula de Bazett.
    [15] Padecer una afección médica preexistente grave que, en opinión del
    investigador, impediría la participación en el estudio (por ejemplo, un
    trastorno gastrointestinal que provoque síntomas clínicamente significativos
    como náuseas, vómitos y diarrea o síndrome de malabsorción).
    [16] Estar recibiendo tratamiento con medicamentos metabolizados por CYP3A4
    con un margen terapéutico estrecho (por ejemplo, alfentanilo, ciclosporina,
    diergotamina, ergotamina, fentanilo, pimozida, quinidina, sirolimús y
    tacrolimús) o por CYP2B6 (por ejemplo, ciclofosfamida, ifosfamida,
    tamoxifeno, efavirenz, propofol, metadona y bupropión).
    [17] Estar recibiendo tratamiento con warfarina o uno de sus derivados, que se
    sabe que alteran los niveles de la proteína C o la proteína S. Se permitirá una
    excepción a este criterio en los pacientes con antecedentes previos de
    síndrome de Budd-Chiari que estén recibiendo tratamiento con warfarina o
    uno de sus derivados.
    [18] Haber recibido un trasplante de células madre hematopoyéticas.
    [19] Presentar una segunda neoplasia maligna primara que a criterio del
    investigador y del promotor pueda afectar a la interpretación de los resultados.
    [20] Padecer una infección fúngica o bacteriana activa o infección vírica conocida,
    incluidas infecciones por el virus de la inmunodeficiencia humana (VIH) o
    hepatitis vírica (A, B o C) (no se precisa selección).
    [21] Tener antecedentes de insuficiencia cardíaca congestiva de clase > 2 según la
    New York Heart Association (los pacientes con clase 1 y 2 del NYHA serán
    elegibles), angina inestable, infarto de miocardio reciente (en los 6 meses
    previos a la administración del medicamento del estudio) o antecedentes
    documentados de arritmia ventricular.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure is objective response as defined by the European LeukemiaNet
    Response Criteria for ET and PV and the International Working Group Consensus Criteria for
    Treatment Response in MF
    La medida principal de la eficacia es la respuesta objetiva, con arreglo a la definición de los
    criterios de respuesta del European LeukemiaNet para la TI y la PV y los criterios consensuados
    del Grupo de trabajo internacional para la respuesta al tratamiento para la MF,
    E.5.1.1Timepoint(s) of evaluation of this end point
    Aprox after all patients have completed 6 cycles of treatment
    Aprox una vez que todos lo paciente hayan completado 6 ciclos de tratamiento
    E.5.2Secondary end point(s)
    Molecular response rate
    Hematological improvement rate
    Decrease in spleen size
    Bone marrow biopsy histology
    Number of thrombotic or hemorrhagic events
    Coagulation factor status
    Frequency of phlebotomies and transfusions
    Duration of response
    Time to best response
    Health outcome measurements
    IPSS, DIPSS, and DIPSS Plus
    Time to treatment failure
    Time to disease progression
    Tasa de respuesta molecular
    Tasa de mejoría hematológica
    Reducción en el tamaño esplénico
    Histología de la biopsia de médula ósea
    Número de episodios trombóticos y hemorrágicos
    Estado de los factores de coagulación
    Frecuencia de flebotomías y transfusiones
    Duración de la respuesta
    Tiempo hasta la mejor respuesta
    Medidas de resultados de salud
    IPSS, DIPSS y DIPSS Plus
    Tiempo hasta el fracaso del tratamiento
    Tiempo hasta la progresión de la enfermedad
    Supervivencia sin progresión
    E.5.2.1Timepoint(s) of evaluation of this end point
    when the study is completed
    Cuando el estudio este finalizado
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Australia
    Austria
    Canada
    France
    Germany
    Italy
    Netherlands
    Spain
    Sweden
    United Kingdom
    United States
    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
    Last patient visit
    ultima visita de 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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 125
    F.4.2.2In the whole clinical trial 150
    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)
    The patient will continue being treated with the standard treatment for his/her disease
    El paciente continuara con el tratamiento habitual 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 Decision2012-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
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