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    Summary
    EudraCT Number:2010-024132-41
    Sponsor's Protocol Code Number:BO21223
    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:2011-11-03
    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 number2010-024132-41
    A.3Full title of the trial
    A MULTICENTER, PHASE III, OPEN-LABEL,
    RANDOMIZED STUDY IN PREVIOUSLY
    UNTREATED PATIENTS WITH ADVANCED
    INDOLENT NON-HODGKIN'S LYMPHOMA
    EVALUATING THE BENEFIT OF GA101
    (RO5072759) PLUS CHEMOTHERAPY
    COMPARED WITH RITUXIMAB PLUS
    CHEMOTHERAPY FOLLOWED BY GA101 OR
    RITUXIMAB MAINTENANCE THERAPY IN
    RESPONDERS
    ESTUDIO MULTICÉNTRICO, FASE III, ABIERTO, ALEATORIZADO, EN PACIENTES CON LINFOMA NO-HODGKIN INDOLENTE AVANZADO, PREVIAMENTE NO TRATADOS PARA EVALUAR EL BENEFICIO DE GA101 (RO5072759) MÁS QUIMIOTERAPIA EN COMPARACIÓN CON RITUXIMAB MÁS QUIMIOTERAPIA SEGUIDA DE TERAPIA DE MANTENIMIENTO CON GA101 O RITUXIMAB EN PACIENTES RESPONDEDORES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of RO5072759 (GA101) Plus Chemotherapy in Comparison With MabThera/Rituxan (Rituximab) Plus Chemotherapy Followed by GA101 or MabThera/Rituxan Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma
    Estudio de RO5072759 (GA101) más quimioterapia en comparación con
    MabThera (rituximab) más quimioterapia seguido de Mantenimiento con
    GA101 o MabThera en pacientes con linfoma no-Hodgkin indolente
    avanzado no tratado.
    A.3.2Name or abbreviated title of the trial where available
    GALLIUM
    GALLIUM
    A.4.1Sponsor's protocol code numberBO21223
    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 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 supportF.Hoffmann-La Roche AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone numbernananana
    B.5.5Fax numbernananana
    B.5.6E-mailglobal.rochegenentechtrials@roche.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.3.1Product nameRO5072759
    D.3.2Product code GA101
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeRO5072759/F06
    D.3.9.3Other descriptive nameGA101
    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 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 Yes
    D.3.11.13.1Other medicinal product typeRO5072759 is a humanized and glycoengineered monoclonal antibody (mAB)
    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 MABTHERA 100 mg 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.3.1Product namerituximab
    D.3.2Product code RO 0452294
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.3Other descriptive nameRITUXIMAB
    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 Yes
    D.3.11.13.1Other medicinal product typemouse/human monoclonal antibody anticuerpo monoclonal quimérico murino/humano
    D.IMP: 3
    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 MABTHERA 500 mg 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 No
    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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.3Other descriptive nameRITUXIMAB
    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 Yes
    D.3.11.13.1Other medicinal product typemouse/human monoclonal antibody
    D.IMP: 4
    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 Bendamustine
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameRibomustin
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNBENDAMUSTINE HYDROCHLORIDE
    D.3.9.1CAS number 3543757
    D.3.9.3Other descriptive nameRibomustin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typeAntineoplastic agent, alkylating agent
    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
    INDOLENT NON-HODGKIN'S LYMPHOMA
    Linfoma no-Hodgkin indolente
    E.1.1.1Medical condition in easily understood language
    INDOLENT NON-HODGKIN'S LYMPHOMA
    Linfoma no-Hodgkin indolente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma up to 7.5 years
    Supervivencia libre de progresión (SLP) evaluada por el investigador según los criterios de respuesta Revised Response Criteria for Malignant Lymphoma hasta 7.5 años
    E.2.2Secondary objectives of the trial
    PFS in the overall study population, investigator-assessed up to
    approximately 7.5 years
    PFS in the overall study population, Independent Review Committee assessed up to approximately 7.5 years
    Response (OR and CR) assessed by the investigator
    up to 168 days
    Response (OR and CR) assessed by Independent Review Committee 168 days
    OS up to approximately 10.7 years
    Event-free survival up to approximately 7.5 years
    Disease-free survival up to approximately 7.5 years
    Duration of response up to approximately 7.5 years
    Time to next anti-lymphoma treatment up to approximately 10.7 years
    Incidence of adverse events up to approximately 10.7 years
    Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire) up to approximately 7.5 years
    Medical resource utilization (hospitalizations, subsequent drug
    Identificador del archivo XML: therapies, medical and surgical procedures) up to approximately 7.5 years
    SLP evaluada por el investigador hasta aproximadamente 7,5 años
    SLP evaluada por el comité de revisión independiente (CRI) , hasta aproximadamente 7,5 años
    Tasas de respuesta global y de respuestas completas (RC) tras el final del tratamiento de inducción, según lo evaluado por el investigador
    Tasas de respuesta global y RC tras el final del tratamiento de inducción, según lo evaluado por el CRI
    Supervivencia global, la supervivencia libre de episodios (SLEp), la supervivencia libre de enfermedad (SLE), la duración de la respuesta hasta aproximadamente 7,5 años y el tiempo hasta el siguiente tratamiento contra el linfoma entre los dos grupos, hasta aproximadamente 10.7 años
    Incidencia de eventos adversos hasta aproximadamente 10.7 años
    Evaluar resultados comunicados por los pacientes (RCP), hasta aproximadamente 7,5 años
    Evaluar la utilización de recursos médicos, hasta aproximadamente 7,5 años
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Biomarker Samples (Stored in the Roche
    Clinical Repository)
    Recogida de muestras para el Banco de Muestras Clínicas de Roche (RCR), INCLUIDO EN EL PROTOCOLO INICIAL, versión 14 de enero de 2011
    E.3Principal inclusion criteria
    Adult patients, >/= 18 years of age
    CD20-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)
    Stage II or IV disease, or Stage II bulky disease
    At least one bi-dimensionally measurable lesion (>2 cm in its largest dimension by CT scan or MRI)
    Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
    Adequate hematologic function"
    Edad mayor igual 18 años.
    LNH de células B, indolente y CD20 positivo (linfoma folicular, LZM
    esplénico, LZM ganglionar o LZM extraganglionar.)
    Enfermedad en estadio III o IV o enfermedad de bulky en estadio II.
    Al menos una lesión medible en dos dimensiones (> 2 cm en su
    dimensión mayor mediante TAC o RM).
    Estado funcional ECOG de 0, 1 o 2
    Función hematológica adecuada
    E.4Principal exclusion criteria
    Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
    - Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia
    - Ann Arbor Stage I disease
    - History of severe allergic or anaphylactic reactions to monoclonal antibody therapy, known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
    - For patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
    - For patients with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy
    - History of prior malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
    - Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
    - Positive for HIV, HTLV1, hepatitis C or chronic hepatitis B"
    -Linfoma del sistema nervioso central, linfoma leptomeníngeo o datos histológicos de transformación en linfoma de alto grado o linfoma difuso de linfocitos B grandes.
    Linfoma folicular de grado 3b, LLCP o MW.
    Enfermedad en estadio I de Ann Arbor
    Hipersensibilidad conocida a productos de origen murino, hipersensibilidad a manitol, a alguno de los fármacos del estudio.
    En los pacientes con linfoma folicular: tratamiento previo para el LNH con quimioterapia, inmunoterapia o radioterapia.
    En los pacientes con linfoma no folicular: tratamiento previo con quimioterapia o inmunoterapia
    Antecedentes de neoplasias malignas previas a excepción de carcinoma de piel de células basales o escamosas tratado con intención curativa y carcinoma de cuello de utero in situ de bajo grado
    Infección activa conocida por bacterias, virus, hongos, micobacterias, parásitos u otras infecciones (excepto micosis de las uñas) o cualquier episodio importante de infección que requiera tratamiento con antibióticos IV u hospitalización (en relación con la finalización del ciclo de antibióticos) en las 4 semanas previas al comienzo del ciclo 1.
    Resultados positivos de las pruebas de hepatitis B crónica, C VIH, HTLV1.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint, PFS in patients with follicular lymphoma,
    is defined as the time from randomization to the first occurrence of progression or
    relapse as assessed by the investigator according to the Revised Response
    Criteria for Malignant Lymphoma (Cheson et al. 2007; see Appendix C), or death
    from any cause. PFS for patients without disease progression, relapse, or death
    will be censored at the time of the last tumor assessment, or if no tumor
    assessments were performed after the baseline visit, at the time of
    randomization.
    El criterio de valoración principal de la eficacia, la SLP en los pacientes con linfoma folicular, se define como el tiempo transcurrido entre la aleatorización y el primer episodio de progresión o recidiva, según lo evaluado por el investigador con arreglo a los Criterios de respuesta revisados para el linfoma maligno, o la muerte por cualquier causa
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 7.5 years
    Hasta aproximadamente 7.5 años
    E.5.2Secondary end point(s)
    Progression-free survival in the overall study population, investigatorassessed
    Progression-free survival, Independent Review Committee - assessed
    Response (overall response and complete response), investigatorassessed
    Response (overall response and complete response), Independent
    Review Committee - assessed
    Overall survival
    Event-free survival
    Disease-free survival
    Duration of response
    Time to next anti-lymphoma treatment
    Safety: Incidence of adverse events
    Patient-reported outcomes (Functional Assessment of Cancer Therapy
    for Lymphoma scale, EuroQol EQ-5D questionnaire)
    Medical resource utilization (hospitalizations, subsequent drug
    therapies, medical and surgical procedures)
    Supervivencia libre de progresión en la población total del estudio,
    evaluados por el investigador
    Supervivencia libre de progresión, evaluado por un Comité de Revisión
    Independiente -
    Respuesta (respuesta global y respuesta completa), evaluados por el
    investigador
    Respuesta (respuesta global y respuesta completa), evaluado
    por Comité de Revisión Independiente -
    La supervivencia global
    Supervivencia libre de eventos
    Supervivencia libre de enfermedad
    Duración de la respuesta
    Tiempo al siguiente tratamiento contra el linfoma
    Seguridad: La incidencia de eventos adversos
    Paciente informó de los resultados (evaluación funcional de la terapia
    contra el cáncer de linfoma escala, EuroQol EQ-5D cuestionario)
    La utilización de recursos médicos (hospitalizaciones, tratamientos
    posteriores de medicamentos, procedimientos médicos y quirúrgicos)
    E.5.2.1Timepoint(s) of evaluation of this end point
    84 days for induction
    168 day for Response
    7.5 to 10.7 years for all other end points
    84 dias para inducción
    168 dias para respuesta
    7.5 to 10.7 años para otros criterios de evaluación
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.2.4Number 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA160
    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
    Argentina
    Australia
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    China
    Colombia
    El Salvador
    Guatemala
    Ireland
    Japan
    Macedonia, the former Yugoslav Republic of
    Mexico
    Panama
    Peru
    Russian Federation
    South Africa
    Taiwan
    Ukraine
    United States
    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
    Last Patient Last Visit
    ultima visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months8
    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.1.2.1Number of subjects for this age range: 504
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 252
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 746
    F.4.2.2In the whole clinical trial 1200
    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)
    After study treatment is left to the Investogator's discression
    Despues del ensayo, el tratamiento se deja a decision del investigador
    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 Decision2011-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-10
    P. End of Trial
    P.End of Trial StatusOngoing
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