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    Summary
    EudraCT Number:2014-000132-41
    Sponsor's Protocol Code Number:B3281006
    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:2014-06-13
    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 number2014-000132-41
    A.3Full title of the trial
    A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586
    VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA
    ESTUDIO EN FASE III, ALEATORIZADO Y DOBLE CIEGO DE PF-05280586 EN COMPARACIÓN CON RITUXIMAB PARA EL TRATAMIENTO DE PRIMERA LÍNEA DE PACIENTES CON LINFOMA FOLICULAR Y BAJA CARGA TUMORAL CD20 POSITIVO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280586 versus commercially available rituximab in treating patients with low tumor burden follicular lymphoma in the first-line treatment setting.
    A.4.1Sponsor's protocol code numberB3281006
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinicalTrials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+3491 490 99 00
    B.5.5Fax number0013037391119
    B.5.6E-mailclinicaltrials.gov_inquiries@pfizer.com
    D. IMP Identification
    D.IMP: 1
    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
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMabThera
    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.3.9.4EV Substance CodeSUB12570MIG
    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 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 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 nameRituximab-Pfizer
    D.3.2Product code PF-05280586
    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 INNnot applicable
    D.3.9.2Current sponsor codePF-05280586
    D.3.9.3Other descriptive nameRituximab-Pfizer
    D.3.9.4EV Substance CodeSUB64137
    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 typeBiosimilar medicinal product
    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
    low tumor burden follicular lymphoma
    linfoma folicular de baja carga tumoral
    E.1.1.1Medical condition in easily understood language
    low tumor burden follicular lymphoma
    linfoma folicular de baja carga tumoral
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    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
    To compare the efficacy of rituximab-Pfizer to rituximab-EU when administered as a first-line treatment to patients with CD20-positive, low tumor burden follicular lymphoma (LTB-FL).
    Comparar la eficacia de rituximab-Pfizer con rituximab-UE al administrarlo como tratamiento de primera línea a pacientes con linfoma folicular y baja carga tumoral (LF-BCT) CD20 positivo.
    E.2.2Secondary objectives of the trial
    ?To evaluate the safety of rituximab-Pfizer and rituximab-EU.
    ?To evaluate the population pharmacokinetics of rituximab-Pfizer and rituximab-EU.
    ?To evaluate the immunogenicity of rituximab-Pfizer and rituximab-EU.
    ?To characterize CD19-positive B-cell depletion and recovery in patients receiving rituximab-Pfizer and rituximab-EU.
    * Evaluar la seguridad de rituximab-Pfizer y rituximab-UE.
    * Evaluar la farmacocinética de la población con rituximab-Pfizer y rituximab-UE.
    * Evaluar la inmunogenia de rituximab-Pfizer y rituximab-UE.
    * Caracterizar la depleción de células B CD19 positivas y la recuperación de los pacientes que reciben rituximab-Pfizer y rituximab-UE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Male or female patients aged 18 years or older.
    2. Histologically confirmed, Grade 1-3a, untreated, CD20-positive follicular lymphoma (containing no elements of diffuse large B-cell lymphoma).
    NOTE: Patients can be entered based on a diagnosis of CD20+ follicular lymphoma confirmed at the investigational site. Archival tissue must be sent to the central pathology reviewer for confirmation of diagnosis. Patients must have tissue available for the central pathology review to be enrolled.
    3. Ann Arbor Stage II, III, or IV.
    4. Eastern Cooperative Oncology Group (ECOG) status of 0 to 1.
    5. At least 1 measureable disease lesion of at least 1.5 cm in longest diameter.
    6.Patient has low tumor burden FL defined as:
    a. Serum LDH within normal limits. b.B2-microglobulin ?1.5 upper limit of normal.
    c. Largest nodal or extra-nodal mass <7 cm in diameter.
    d. No more than 3 nodal sites with a diameter >3 cm.
    e. No significant serous effusions detectible clinically or on chest radiography.
    f. Spleen enlargement ?16 cm by CT scan.
    g. No complications such as organ compression or impairment.
    h. No B symptoms:
    * fever >38ºC for 3 consecutive days;
    * recurrent, drenching night sweats;
    * Unintentional weight loss exceeding 10% body weight in 6 months.
    NOTE: Patients with mild FL symptoms may be enrolled in the study as long as they do not meet the criteria for B symptoms.
    7. Men and Women of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 12 months after the last dose of assigned treatment. A man or woman is of childbearing potential if, in the opinion of the investigator, he or she is biologically capable of having children and is sexually active.
    8. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
    9. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    1. Deben ser hombres y mujeres mayores de 18 años.
    2. Linfoma folicular CD20 positivo, de grado 1-3a confirmado histológicamente y sin tratar (sin que contenga elementos de linfoma difuso de células B grandes).
    NOTA: los pacientes pueden participar en el estudio basándose en un diagnóstico de linfoma folicular CD20+ confirmado en el centro de investigación. El tejido de archivo debe enviarse al revisor de patología central para la confirmación del diagnóstico. Para que los pacientes puedan participar en el estudio deben tener tejido disponible para la revisión de patología central.
    3. Estadio II, III, o IV de Ann Arbor (Apéndice 1).
    4. Estado funcional según la escala ECOG (Eastern Cooperative Oncology Group) de 0 a 1.
    5. Al menos 1 lesión de la enfermedad medible de al menos 1,5 cm de diámetro mayor.
    6. El paciente tiene LF con baja carga tumoral definido como:
    a. LDH sérica en los límites normales.
    b. B2-microglobulina ? 1,5 el límite superior de la normalidad.
    c. Mayor masa ganglionar o extraganglionar <7 cm de diámetro.
    d. No más de 3 áreas ganglionares con un diámetro >3 cm.
    e. Derrames serosos no significativos detectables clínicamente o mediante radiografía de tórax.
    f. Aumento del tamaño del bazo ?16 cm mediante TC.
    g. Ausencia de complicaciones tales como compresión o insuficiencia orgánica.
    h. Ausencia de síntomas B:
    - fiebre >38 ºC durante 3 días consecutivos;
    - sudoración nocturna copiosa y recurrente;
    - pérdida involuntaria de peso superior al 10 % del peso corporal en 6 meses.
    NOTA: puede incluirse en el estudio a pacientes con síntomas leves de LF siempre que no cumplan los criterios de síntomas B.
    7. Los hombres y mujeres en edad fértil deben acceder a utilizar un método anticonceptivo de eficacia elevada durante todo el estudio y durante 12 meses después de la última dosis del tratamiento asignado. Se considera que un hombre o una mujer está en edad fértil si, a juicio del investigador, está capacitada/o biológicamente para tener hijos y es sexualmente activa.
    8. Evidencia de un documento de consentimiento informado fechado y firmado personalmente que indique que el paciente ha sido informado de todos los aspectos pertinentes del estudio.
    9. Los pacientes deben ser capaces de, y estar dispuestos a, cumplir con las visitas programadas, el plan de tratamiento, las pruebas analíticas y otros procedimientos del estudio.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. Patients who are not candidates for rituximab monotherapy in the opinion of the investigator.
    2. Evidence of histologic transformation to high-grade or diffuse large B-cell lymphoma.
    3. Central nervous system or meningeal involvement or cord compression by the lymphoma.
    4. T-cell lymphoma.
    5. Subjects with ? 5000/mm3 circulating lymphoma cells
    6. Any prior therapy for lymphoma, including steroids. (Low dose [10 mg oral prednisone or equivalent] or inhaled steroids for other conditions are acceptable).
    7. Any prior treatment with rituximab.
    8. Hypersensitivity to the active substances or to any of the excipients in rituximab-Pfizer or rituximab-EU.
    9. Hypersensitivity to murine proteins.
    10.Impaired bone marrow function as evidenced by hemoglobin < 9.0 g/dL, absolute neutrophil count (ANC) < 1.5 x 10x9 cells/L (1500/mm3) or a platelet count <75 x 10x9cells/L (75,000/mm3).
    11. Symptomatic ischemic heart disease or NYHA Class II, III, or IV congestive heart failure.
    12. Active infection with tuberculosis (TB). Patients with evidence of latent TB or a history of TB must have completed treatment or have initiated treatment for at least 1 month before the first dose of study treatment (Day 1). TB testing is required only if it is required by local regulations or practice.
    13. Current or chronic hepatitis B or C infection as evidenced by hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or anti-hepatitis C antibody positivity, respectively, or known seropositivity for human immunodeficiency virus (HIV). (Patients with active hepatitis B disease should not be treated with MabThera. Patients with positive hepatitis B serology [either HBsAg or HBcAb] should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation).
    14. Any other active uncontrolled infection. Patients with an infection must have initiated a course of treatment with an effective antibiotic a minimum of 7 days before the first dose of study treatment (Day 1) and be free of symptoms from the infection.
    15. Any history of other cancer during the last 5 years with the exception of those patients treated with curative intent with no evidence of metastatic disease or history of non-melanoma skin tumors, in situ cervical carcinoma, or in situ breast cancer.
    16. Administration of a live vaccine ? 6 weeks before first dose of study treatment (Day 1).
    17. Major surgery ?28 days before first dose of study treatment.
    18. Anticipated need for concomitant administration of any other experimental drug, or a concomitant chemotherapy, anticancer hormonal therapy, radiotherapy, or immunotherapy during study participation.
    19. Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks or 5 half-lives, whichever is longer, before the current study begins and/or during study participation.
    20. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    21. Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the trial.
    22. Pregnant females; breastfeeding females; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 12 months after last dose of investigational product.
    23. Patients with a body surface area > 3.0 m2
    1. Pacientes que no son candidatos para rituximab en monoterapia en opinión del investigador.
    2. Evidencia de transformación histológica a linfoma difuso de células B grandes o de alto grado.
    3. Afectación del sistema nervioso central o meníngea o compresión medular por el linfoma.
    4. Linfoma de células T.
    5. Pacientes con células linfoma circulantes ? 5000/mm3
    6. Cualquier tratamiento previo para el linfoma, incluyendo esteroides. (Se aceptan dosis bajas [10 mg de prednisona oral o equivalente] o esteroides inhalados para otras afecciones).
    7. Cualquier tratamiento previo con rituximab.
    8. Hipersensibilidad a los principios activos o a alguno de los excipientes de riuximab-Pfizer o rituximab-UE.
    9. Hipersensibilidad a proteínas murinas.
    10. Insuficiencia de la función de la médula ósea evidenciada por niveles de hemoglobina <9,0 g/dl, recuento absoluto de neutrófilos (RAN) <1,5 x 109 células/l (1500/mm3) o un recuento de plaquetas <75 x 109 células/l (75 000/mm3).
    11. Cardiopatía isquémica sintomática o insuficiencia cardíaca congestiva de clase II, III o IV según la Asociación del Corazón de Nueva York (New York Heart Association, NYHA).
    12. Infección activa con tuberculosis (TB). Los pacientes con evidencia de TB latente o antecedentes de TB deben haber finalizado el tratamiento o haber iniciado el tratamiento durante al menos 1 mes antes de la primera dosis del tratamiento del estudio (día 1). Las pruebas de TB solo deben realizarse si así lo exigen las normativas o práctica locales.
    13. Infección actual o crónica por hepatitis B o C evidenciada por el antígeno de superficie de la hepatitis B (HBsAg), anticuerpo contra el antígeno nuclear de la hepatitis B (HBcAb) o positividad para anticuerpo anti-hepatitis C, respectivamente, seropositividad conocida para el virus de la inmunodeficiencia humana (VIH). (Los pacientes con hepatitis B activa no deben ser tratados con MabThera. Los pacientes con serología positiva por hepatitis B [HBsAg o HBcAb] deben consultar con expertos en enfermedades hepáticas antes de iniciar el tratamiento y deben supervisarse y tratarse siguiendo los estándares médicos locales para prevenir la reactivación de la hepatitis B).
    14. Cualquier otra infección activa no controlada. Los pacientes con una infección deben haber iniciado el tratamiento con un antibiótico eficaz un mínimo de 7 días antes de la primera dosis del tratamiento del estudio (día 1) y no presentar síntomas de la infección.
    15. Cualquier antecedente de otro tipo de cáncer durante los últimos 5 años, con la excepción de aquellos pacientes tratados con intención curativa y sin evidencia de enfermedad metastásica o antecedentes de tumores de piel no melanoma, carcinoma cervical in situ, o cáncer de mama in situ.
    16. Administración de una vacuna viva ?6 semanas antes de la primera dosis del tratamiento del estudio (día 1).
    17. Cirugía mayor ?28 días antes de la primera dosis del tratamiento del estudio.
    18. Necesidad prevista de administración concomitante de otros fármacos en investigación, o quimioterapia concomitante, terapia hormonal contra el cáncer, radioterapia, o inmunoterapia durante la participación en el estudio.
    19. Participación en otros estudios con otros fármacos en investigación (fases I-IV) en el plazo de 4 semanas o 5 semividas, lo que sea más largo, antes del inicio del estudio actual o durante la participación en el estudio.
    20. Presencia de cualquier otro trastorno médico o psiquiátrico grave, agudo o crónico, o cualquier anomalía analítica que pueda aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o interferir en la interpretación de los resultados del estudio y que, en opinión del investigador, pueda impedir la participación en este estudio.
    21. Pacientes que sean miembros del personal del centro de investigación directamente implicados en la realización del ensayo, así como sus familiares, miembros del personal del centro supervisados de alguna otra manera por el investigador, o pacientes que sean empleados de Pfizer directamente implicados en la realización del ensayo.
    22. Mujeres embarazadas; mujeres en periodo de lactancia; mujeres en edad fértil que no desean o no pueden usar un método anticonceptivo de elevada eficacia tal como se describe en este protocolo durante todo el estudio y 12 meses después de la última dosis del producto en investigación.
    23. Pacientes con una superficie corporal > 3.0 m2
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR) at Week 26 of rituximab-Pfizer and rituximab-EU based on central radiology review in accordance with the revised response criteria for malignant lymphoma
    Tasa de respuesta global (TRG) en la semana 26 de rituximab-Pfizer y rituximab-UE basada en una revisión de radiología central conforme a los criterios de respuesta revisados para el linfoma maligno
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26
    semana 26
    E.5.2Secondary end point(s)
    ?Safety characterized by type, incidence, severity, timing, seriousness, and relationship to study therapy of adverse events and laboratory abnormalities.
    ?Time to Treatment Failure (TTF).
    ?Progression-Free Survival (PFS).
    ?Complete Remission (CR) rate at Week 26.
    ?Duration of response.
    ?Overall survival.
    ?Peak and trough drug concentrations.
    ?CD19-positive B-cell counts.
    ?Incidence of anti-drug antibodies (ADA), including neutralizing antibodies (NAb), and safety associated with immune response.
    * Seguridad caracterizada por el tipo, la incidencia, la intensidad, el momento, la gravedad y la relación de los acontecimientos adversos y las anomalías analíticas con el tratamiento del estudio.
    * Tiempo hasta el fracaso del tratamiento (TFT).
    * Supervivencia libre de progresión (SLP).
    * Tasa de remisión completa (RC) en la semana 26.
    * Duración de la respuesta.
    * Supervivencia global.
    * Concentraciones máximas y mínimas del fármaco.
    * Recuentos de células B CD19 positivas.
    * Incidencia de los anticuerpos contra el fármaco (ACF), incluyendo los anticuerpos neutralizantes (AcN) y la seguridad asociada con la respuesta inmunitaria
    E.5.2.1Timepoint(s) of evaluation of this end point
    please refer to the 'Schedule of Activities' table provided within the protocol pages 7-9.
    por favor, refiérase a la tabla de "calendario de actividades" que se encuentra en el protocolo páginas 7 y 8
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    inmunogenicidad
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Argentina
    Australia
    Belarus
    Belgium
    Brazil
    Croatia
    France
    Germany
    Greece
    India
    Italy
    Japan
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    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
    as per Protocol Section 13.
    según la sección 13 del protocolo
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 157
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 237
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 106
    F.4.2.2In the whole clinical trial 394
    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)
    As per protocol
    Según protocolo
    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 Decision2014-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-18
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