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    Summary
    EudraCT Number:2010-024194-39
    Sponsor's Protocol Code Number:BO21005
    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:2011-02-17
    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 number2010-024194-39
    A.3Full title of the trial
    ENSAYO DE FASE III, MULTICÉNTRICO, ABIERTO Y ALEATORIZADO PARA COMPARAR LA EFICACIA DE GA101 (RO5072759) EN COMBINACIÓN CON CHOP (G-CHOP) FRENTE A RITUXIMAB Y CHOP (R-CHOP) EN PACIENTES CON LINFOMA DIFUSO DE CÉLULAS B GRANDES (LDCBG) CD20 POSITIVO NO TRATADOS PREVIAMENTEA PHASE III, MULTICENTER, OPEN-LABEL, RANDOMIZED TRIAL COMPARING THE EFFICACY OF GA101 (RO5072759) IN COMBINATION WITH CHOP (G-CHOP) VERSUS RITUXIMAB AND CHOP (R-CHOP) IN PREVIOUSLY UNTREATED PATIENTS WITH CD20 POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)
    A.4.1Sponsor's protocol code numberBO21005
    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 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 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.3.9.1CAS 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) 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 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.3.4Pharmaceutical 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 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) 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 typemouse/human monoclonal antibody
    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 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 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) 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 typemouse/human monoclonal antibody
    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
    PREVIOUSLY UNTREATED PATIENTS WITH CD20-POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) Pacientes CD20+ con linfoma difuso de celulas B grandes que no han sido previamente tratados
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level HLT
    E.1.2Classification code 10012819
    E.1.2Term Diffuse large B-cell lymphomas
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este estudio es demostrar la superioridad en cuanto a la supervivencia libre de progresión (SLP) de GA101 más quimioterapia (G-CHOP) con respecto a rituximab más quimioterapia (R-CHOP) en pacientes con linfoma difuso de células B grandes CD20-positivo (LDCBG) no tratados previamente, en función de la SLP evaluada por el investigador.Outcome Measure: Progression-free survival, assessed by the investigator according to a modified version of the Revised Response Criteria for Malignant Lymphoma
    up to approximately 78 months
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de este estudio son los siguientes:
    Evaluar y comparar la supervivencia global (SG) entre los dos grupos tratados con la combinación de G-CHOP o de R-CHOP.
    Evaluar y comparar la tasa de respuesta global y la tasa de respuestas completas (RC) después del final del tratamiento entre los dos grupos, según el criterio del investigador.
    Evaluar y comparar la SLP entre los 2 grupos, según la evaluación del comité de revisión independiente (CRI).
    Evaluar y comparar la tasa de respuestas globales y la tasa de RC entre los dos grupos según la evaluación del CRI después del final fin del tratamiento.
    Evaluar y comparar la supervivencia libre de eventos (SLEv) entre los dos grupos, según el criterio del investigador.
    Evaluar y comparar la supervivencia libre de enfermedad (SLE), la duración de la respuesta (DR) y el tiempo hasta el siguiente tratamiento para el linfoma (TSTL) entre los dos grupos.
    OS up to approximately 78 months
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    La recogida de muestras para el Banco de Muestras Clínicas de Roche (RCR) , INCLUIDO EN EL PROTOCOLO INICIAL, vers 6 de enero de 2011.
    E.3Principal inclusion criteria
    LDCBG CD20-positivo, no tratado previamente, documentado histológicamente mediante:
    El informe anatomopatológico deberá estar disponible para su revisión, y se enviará un bloque de tejido para su confirmación central retrospectiva.
    Se prefieren bloques de tejido fijados en formol e incluidos en parafina; sin embargo, en los países en los que se utilice otro fijador, se aceptará cualquier bloque de tejido disponible, y se indicará el tipo de fijador utilizado.
    Si no se dispone de un bloque de tejido, se aceptarán 15 laminillas no teñidas.
    La muestra opcional para el RCR y la muestra obligatoria para la evaluación de biomarcadores exploratorios se obtendrán del mismo bloque de tejido. Si no fuera posible la confirmación central con el material presentado, también podrán solicitarse las extensiones teñidas que se utilizaron para el diagnóstico.
    Una de estas puntuaciones del riesgo de enfermedad IPI: riesgo bajo-intermedio, alto-intermedio o alto (véase el apéndice F).
    Los pacientes con riesgo bajo de enfermedad según el IPI serán elegibles si presentan una afectación masiva (una lesión 7,5 cm).
    Al menos una lesión medible en dos dimensiones, definida por una dimensión máxima > 1,5 cm en el TAC.
    Capacidad y disposición para cumplir todos los procedimientos del protocolo del estudio.
    Edad 18 años.
    Estado funcional ECOG de 0, 1 o 2 (véase el apéndice G).
    FEVI 50% en la ventriculografía isotópica (MUGA) o en la ecocardiografía.
    Función hematológica adecuada, definida como sigue:
    Hemoglobina 9 g/dl.
    Recuento absoluto de neutrófilos 1,5 x 109/l.
    Recuento de plaquetas 75 x 109/l.
    En los varones que no hayan sido esterilizados quirúrgicamente: compromiso de utilizar un método anticonceptivo de barrera durante todo el período de tratamiento y durante 3 meses después de la última dosis de GA101 o de rituximab, o de conformidad con las directrices del centro para CHOP, lo que suponga más tiempo, y de pedir a su pareja que utilice otro método anticonceptivo, como anticonceptivos orales, dispositivo intrauterino, método de barrera o gel espermicida.
    En las mujeres en edad fértil que no estén esterilizadas quirúrgicamente: compromiso de utilizar dos métodos anticonceptivos adecuados, como anticonceptivos orales, dispositivo intrauterino o método de barrera junto con un gel espermicida durante el período de tratamiento y durante 12 meses después de la última dosis de GA101 o de rituximab, o de conformidad con las directrices del centro para CHOP, lo que suponga más tiempo.
    Adult patients, >/= 18 years of age
    Previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL)
    At least 1 bi-dimensionally measurable lesion (>1.5 cm in is largest dimension on the CT scan)
    Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
    Adequate hematological function
    E.4Principal exclusion criteria
    Antecedentes de reacciones alérgicas o anafilácticas graves a los anticuerpos monoclonales humanizados o murinos, o sensibilidad o alergia a los productos de origen murino.
    Contraindicación de cualquiera de los componentes individuales de CHOP, incluido el tratamiento previo con antraciclinas.
    Diagnóstico de linfoma transformado (folicular IIIB), si se ha tratado previamente con radioterapia, quimioterapia o inmunoterapia.
    Tratamiento previo para el LDCBG, a excepción de biopsia ganglionar o irradiación local.
    Tratamiento previo con fármacos citotóxicos o con rituximab para otros trastornos (por ejemplo, artritis reumatoide) o uso previo de un anticuerpo anti-CD20
    Uso previo de anticuerpos monoclonales en los 3 meses previos al inicio del ciclo 1.
    Uso actual de corticosteroides en dosis > 30 mg/día de prednisona o equivalente.
    Los pacientes que reciban tratamiento con corticosteroides con 30 mg/día de prednisona o equivalente deberán demostrar que no se ha modificado la dosis en las 4 semanas previas a la aleatorización, como mínimo (día 1 del ciclo 1).
    Linfoma primario del SNC, variante blástica del LCM o indicios histológicos de transformación en linfoma de Burkitt, LDCBG mediastínico primario, linfoma con derrame primario y LDCBG cutáneo primario.
    Vacunación con vacunas de microorganismos vivos en los 28 días previos a la aleatorización.
    Quimioterapia u otro tratamiento experimental en los 28 días anteriores al inicio del ciclo 1.
    Antecedentes de otros procesos malignos que puedan afectar al cumplimiento del protocolo o a la interpretación de los resultados.
    Podrán participar los pacientes con antecedentes de carcinoma basocelular o epidermoide o melanoma de la piel, o de carcinoma in situ de cuello uterino tratados curativamente.
    También se descartará a los pacientes con una neoplasia maligna que haya sido tratada, pero no con fines curativos, a menos que dicha neoplasia haya estado en remisión sin tratamiento durante 5 años antes del reclutamiento.
    Indicios de enfermedades concomitantes no controladas e importantes que puedan afectar al cumplimiento del protocolo o a la interpretación de los resultados, tales como enfermedad cardiovascular importante (enfermedad cardíaca de clase III o IV de la New York Heart Association, infarto de miocardio en los 6 últimos meses, arritmias inestables o angina inestable) o enfermedad pulmonar (enfermedad pulmonar obstructiva o antecedentes de broncoespasmo).
    Intervención de cirugía mayor reciente (en las 4 semanas anteriores al inicio del ciclo 1), excepto para el diagnóstico.
    Cualquiera de los valores analíticos anómalos siguientes:
    Creatinina > 1,5 veces el límite superior de la normalidad (LSN) (a menos que el aclaramiento de creatinina sea normal) o aclaramiento de creatinina calculado < 40 ml/min (con la fórmula de Cockcroft-Cockcroft; véase el apéndice H).
    Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) > 2,5 x LSN
    Bilirrubina total 1,5 x LSN: Los pacientes con antecedentes documentados de enfermedad de Gilbert podrán participar si la bilirrubina total es 3,0 x LSN.
    Cociente internacional normalizado (INR) > 1,5 x LSN en ausencia de anticoagulación terapéutica.
    Tiempo de tromboplastina parcial (TTP) o tiempo de tromboplastina parcial activada (TTPa) > 1,5 x LSN sin anticoagulante lúpico.
    Resultados positivos de las pruebas de hepatitis B crónica (definida por la serología positiva para HBsAg).
    Se podrá reclutar a un máximo de 100 pacientes con hepatitis B oculta o previa (que se define por anticuerpos contra el núcleo del virus de la hepatitis B [HBcAb] positivos y HBsAg negativo) si el ADN del VHB es indetectable. Los pacientes deberán estar dispuestos a someterse a una prueba de ADN mensual.
    Resultados positivos para la hepatitis C (serología de anticuerpos contra el virus de la hepatitis C [VHC]).
    Los pacientes VHC positivos solo podrán participar si el resultado de la PCR es negativo para el ARN del VHC.
    Antecedentes de infección por el VIH.
    Resultados positivos para el virus linfotrópico de células T humano (VLTH 1).
    La prueba del VLTH es necesaria para los pacientes de centros en países endémicos (Japón y Melanesia y países del Caribe, Sudamérica, Centroamérica y África subsahariana).
    Embarazo o lactancia.
    Esperanza de vida < 12 meses.
    History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
    Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
    Diagnosis of transformed lymphoma (follicular IIIB) if previously treated with radiotherapy, chemotherapy, or immunotherapy
    Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
    Prior treatment with cytotoxic drugs or rituximab for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody
    Prior use of any monoclonal antibody within 3 months of
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal de este estudio es la SLP evaluada por el investigador, que se define como el tiempo transcurrido desde la aleatorización hasta el primer episodio de progresión o recidiva, mediante una versión modificada de los criterios de respuesta revisados para el linfoma maligno (Cheson y cols. 2007; véase el apéndice B) o hasta la muerte por cualquier causaThe primary efficacy endpoint is PFS, as determined by the investigator, defined as the time from the date of randomization until the first occurrence of disease progression, relapse, or death from any cause.
    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 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 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) 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.8.3 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 concerned11
    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
    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 fin del estudio se define como la última visita del último paciente y tendrá lugar aproximadamente 6,5 años (78 meses) después del reclutamiento del primer paciente, para que todos los pacientes cuenten con al menos 3 años de seguimiento después del tratamiento. El promotor tiene derecho a poner fin a este estudio en cualquier momentoThe end of the study is defined as the last patient?s last visit and will occur
    approximately 6.5 years (78 months) after the first patient is enrolled to allow
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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 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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 750
    F.4.2.2In the whole clinical trial 1400
    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 Decision2011-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-31
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