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    Summary
    EudraCT Number:2013-005542-11
    Sponsor's Protocol Code Number:20130109
    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:2014-07-04
    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 number2013-005542-11
    A.3Full title of the trial
    A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared with Rituximab in Subjects with CD20 Positive B-Cell Non-Hodgkin Lymphoma (NHL)
    Ensayo aleatorizado y doble ciego para evaluar la eficacia, la seguridad y la inmunogenicidad de ABP 798 en comparación con rituximab en sujetos con linfoma no Hodgkin (LNH) de células B CD20+.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The trial is designed to determine the efficacy and safety of ABP 798 compared with rituximab in subjects with CD 20 positive B-cell non Hodgkin lymphoma
    El ensayo se ha diseñado para determinar la eficacia y la seguridad de ABP 798 en comparación con rituximab en sujetos con linfoma no Hodgkin (LNH) de células B CD20+.
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code number20130109
    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 SponsorAmgen Inc.
    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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, PO Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfointernational@amgen.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 nameABP 798
    D.3.2Product code ABP 798
    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 1446410-99-6
    D.3.9.2Current sponsor codeABP 798
    D.3.9.3Other descriptive nameABP 798 - Biosimilar to rituximab
    D.3.9.4EV Substance CodeSUB130918
    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 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 Rituxan
    D.2.1.1.2Name of the Marketing Authorisation holderGenentech, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.9.4EV 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.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
    CD20 positive B-cell non-Hodgkin lymphoma
    Linfoma no Hodgkin (LNH) de células B CD20+.
    E.1.1.1Medical condition in easily understood language
    CD20 positive B-cell non-Hodgkin lymphoma
    Linfoma no Hodgkin (LNH) de células B CD20+.
    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 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 evaluate the efficacy of ABP 798 compared with rituximab
    Evaluar la eficacia del ABP 798 comparada con la del rituximab.
    E.2.2Secondary objectives of the trial
    To assess the pharmacokinetics (PK), pharmacodynamics, safety, tolerability, and immunogenicity of ABP 798 compared with rituximab
    Estudiar la farmacocinética, la farmacodinámica, la seguridad, la tolerabilidad y la inmunogenicidad del ABP 798 en comparación con el rituximab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males and females > or = 18 and < 80 years of age.

    Histological confirmed, Grade 1, 2 follicular B-cell NHL expressing CD20 within 3 months before randomization.

    Stage 2, 3, or 4 (per Cotswold?s Modification of Ann Arbor Staging System) with measurable disease (per International Working Group)
    - subjects must have a baseline scan (computed tomography [CT]) of the neck (if palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease burden within 28 days before randomization
    - subjects must have had a baseline bone marrow biopsy within 3 months before randomization.

    Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria.

    Blood counts:
    - absolute neutrophil count (ANC) > or = 1.5 x 109 g/dL (1,500/?L)
    - lymphocytes < 1.5 x the upper limit of normal (ULN)
    - platelets > or = 100 x 109 g/dL (100,000/?L)
    - hemoglobin ? 10.0 g/dL

    Adequate hepatic function as defined by:
    -aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 × ULN.

    Adequate renal function as defined by creatinine < 1.5 x ULN or estimated creatinine clearance > or = 50 mL/min calculated by the Cockcroft-Gault method.
    Sexo masculino o femenino y > o = 18 y < 80 años de edad.

    Confirmación histopatológica, en los 3 meses antes de la aleatorización, del diagnóstico de LNH folicular de células B, de grado 1 o 2 y con expresión de CD20.

    Estadio 2, 3 o 4 (según la modificación de Cotswold del sistema de estadiaje de Ann Arbor) y lesiones mensurables (según el International Working Group):
    -pacientes con realización de un estudio oncológico basal: tomografía axial computarizada (TAC) del cuello (si se palpan ganglios > 1,0 cm), el tórax, el abdomen y la pelvis para calcular la masa tumoral en los 28 días antes de la aleatorización;
    - pacientes con biopsia de médula ósea en los 3 meses antes de la aleatorización.

    Masa tumoral reducida según los criterios del Groupe D'Étude des Lymphomes Folliculaires (GELF).

    Hematimetría:
    -cifra absoluta de neutrófilos (CAN) > o = 1,5 × 109 g/dl (1500/?l);
    -linfocitos < 1,5 el límite superior de la normalidad (LSN);
    -plaquetas > o = 100 x 109 g/dl (100.000/?l);
    -hemoglobina > o = 10,0 g/dl.

    Normofunción hepática, definida por los valores siguientes:-aspartato-aminotransferasa (ASAT) y alanina-aminotransferasa (ALAT) < 2 × LSN;

    Normofunción renal definida por una creatinina < 1,5 × LSN o un aclaramiento de creatinina > o = 50 ml/min según lo estimado con la fórmula de Cockcroft-Gault.
    E.4Principal exclusion criteria
    Diffuse large cell component and/or Grade 3 follicular NHL.

    History or known presence of central nervous system metastases.

    Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or squamous or basal cell carcinoma of the skin).

    Any of the following before randomization:
    -clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure [New York Heart Association ? Class III], serious uncontrolled cardiac arrhythmia);
    - peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months.

    Medically uncontrolled hypertension or systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg.

    Known active or history of active tuberculosis (TB).

    Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at screening.

    Known to be human immunodeficiency virus positive.

    Recent infection requiring a course of systemic anti-infective agents that was completed < or = 7 days before randomization (with the exception of uncomplicated urinary tract infection).

    Subject is currently enrolled in or has not yet completed at least 30 days or 5 half-lives (whichever is longer) since ending other investigational device or drug study(s), including vaccines, or subject is receiving other investigational agent(s).

    Previous use of either commercially available or investigational chemotherapy, biological, or immunological therapy for NHL (including rituximab or biosimilar rituximab, or other anti-CD20 treatments).

    Live vaccines within 28 days prior to the first dose of IP.

    History of neurologic symptoms suggestive of central nervous system demyelinating disease
    Woman of childbearing potential who is pregnant or is breastfeeding.

    Woman of childbearing potential who does not consent to use highly effective methods of birth control (eg, true abstinence, sterilization, birth control pills, Depo Provera injections, or contraceptive implants) during treatment and for an additional 12 months after the last administration of the protocol specified-treatment.

    Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control (eg, true abstinence, vasectomy, or a condom in combination with hormonal birth control or barrier methods used by the woman) during treatment and for an additional 12 months after the last administration of the protocol specified treatment.

    Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products
    LNH con componente difuso de células grandes o LNH folicular de grado 3.

    Antecedentes o presencia de metástasis en el sistema nervioso central.

    Antecedentes, en los últimos 5 años, de otras neoplasias malignas distintas del LNH (excepto el carcinoma de cuello uterino in situ y los carcinomas basocelular o espinocelular de la piel si se han tratado).

    Antecedentes previos a la aleatorización de:
    -enfermedad cardiovascular de relevancia clínica (infarto de miocardio, angina inestable, insuficiencia cardíaca congestiva sintomática [clase ? III según la New York Heart Association], arritmias cardíacas graves sin controlar);
    -vasculopatía periférica, ictus o accidente isquémico transitorio en los últimos 6 meses.

    Hipertensión no controlada farmacológicamente o tensión arterial sistólica > 160 mmHg o diastólica > 100 mmHg.

    Antecedentes o presencia de tuberculosis activa.

    Positividad del antígeno de superficie del VHB, anticuerpos contra el antígeno central del VHB o anticuerpos contra el VHC en la selección.

    Seropositividad del virus de la inmunodeficiencia humana.

    Infección reciente que haya requerido un curso de antibioterapia sistémica si éste finalizó < or = 7 días antes de la aleatorización (con la salvedad de las infecciones urinarias sin complicaciones).
    Participación actual en una investigación con un fármaco, vacuna o producto sanitario experimental o no haber pasado 30 días o 5 semividas (lo que resulte más prolongado) desde que finalizase la participación en un proyecto de estas características, o tratamiento actual con un fármaco en fase de investigación.

    Antecedentes de inmunoterapia, productos biológicos o quimioterapia contra el LNH, ya sean tratamientos comercializados o en fase de investigación (incluido el rituximab o cualquier producto bioequivalente y otros tratamientos anti-CD20).

    Administración de una vacuna con microbios vivos en los 28 días anteriores a la primera dosis del producto en investigación.

    Antecedentes de síntomas neurológicos indicativos de enfermedad desmielinizante del sistema nervioso central.

    Embarazo o lactancia materna en el caso de las mujeres en edad fértil.

    En el caso de las mujeres en edad fértil, no comprometerse a emplear anticonceptivos de gran eficacia (p. ej., abstinencia sexual absoluta, esterilización quirúrgica, píldora anticonceptiva, inyecciones de Depo-Progevera o implantes) durante el tratamiento indicado en el protocolo y durante los 12 meses siguientes a la última dosis.

    En el caso de los varones cuya pareja sea mujer en edad fértil, no comprometerse a emplear anticonceptivos de gran eficacia (p. ej., abstinencia sexual absoluta, vasectomía, preservativos junto con otro método mecánico u hormonal empleado por la pareja) durante el tratamiento indicado en el protocolo y durante los 12 meses siguientes a la última dosis.

    Sujetos con sensibilidad conocida a alguno de los productos que se administrarán en el marco del ensayo, incluidos los fármacos derivados de células de mamíferos.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint: (risk difference [RD] of objective response rate [ORR] by week 28
    Criterio principal de valoración de la eficacia:
    Diferencia del riego (DR) de la tasa de respuesta global (TRG) a la semana 28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical disease assessment & PK sampling: v1 (D1), v2 (w2), v3 (w3), v4 (w4), v5 (w12), v6 (w20), end of study (w28)

    CT Scan: screening, v5 (w12), end of study (w28)

    Bone marrow biopsy: screening, end of study (w28)

    Serum chemistry & Hematology: screening, v1 (D1), v2 (w2), v3 (w3), v4 (w4), v5 (w12), v6 (w20), end of study (w28)

    Pharmacodynamic (CD19) and IgG and IgM: v1 (D1), v2 (w2), v3 (w3), v4 (w4), end of study (w28)
    Evaluación clínica de la enfermedad y muestras de farmacocinética: v1 (D1), v2 (sem.2), v3 (sem.3), v4 (sem.4), v5 (sem.12), v6 (sem.20), fin del ensayo (sem.28).

    TAC: selección, v5 (sem.12), fin del ensayo (sem.28)

    Biopsia de medula ósea: selección, fin del ensayo (sem.28)

    Bioquímica Sérica & Hematología: selección, v1 (D1), v2 (sem.2), v3 (sem.3), v4 (sem.4), v5 (sem.12), v6 (sem.20), fin del ensayo (sem.28)

    Farmacodinámica (CD19) y IgG y IgM: v1 (D1), v2 (sem.2), v3 (sem.3), v4 (sem.4), fin del ensayo (sem.28)
    E.5.2Secondary end point(s)
    Secondary Efficacy Criteria: Risk difference (RD) of overall response rate (ORR) at week 12.

    Pharmacokinetic and Pharmacodynamic Criteria:
    - Serum concentrations at predose and immediately after the end of infusion at weeks 4, 12, and 20.
    -Percent of subjects with complete depletion of CD19 cell count, from baseline to study day 8, and total IgG and IgM antibody levels

    Safety Criteria:
    -Treatment-emergent adverse events (AEs) and serious AEs (SAEs)
    -Clinically significant changes in laboratory values and vital signs
    -Incidence of anti-drug antibodies
    -On study progression-free survival (PFS)
    -On study overall survival (OS)
    Diferencia del riego (DR) de la tasa de respuesta global (TRG) a la semana 12.

    Criterios de valoración de la farmacocinética y la farmacodinámica:
    -Concentración sérica antes de la infusión e inmediatamente después, las semanas 4, 12 y 20.
    -Porcentaje de sujetos con eliminación absoluta de linfocitos CD19 entre el inicio del tratamiento y el día 8 y las concentraciones totales de anticuerpos IgG e IgM.


    Criterios de valoración de la seguridad:
    -Acontecimientos adversos (AA) y AA graves (AAG) aparecidos durante el tratamiento.
    -Alteraciones de relevancia clínica en los análisis de laboratorio o en las constantes vitales.
    -Incidencia de anticuerpos contra el fármaco.
    -Supervivencia sin progresión (SSP) durante el ensayo.
    -Supervivencia global (SG) durante el ensayo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical disease assessment & PK sampling: v1 (D1), v2 (w2), v3 (w3), v4 (w4), v5 (w12), v6 (w20), end of study (w28)

    CT Scan: screening, v5 (w12), end of study (w28)

    Bone marrow biopsy: screening, end of study (w28)

    Serum chemistry & Hematology: screening, v1 (D1), v2 (w2), v3 (w3), v4 (w4), v5 (w12), v6 (w20), end of study (w28)

    Pharmacodynamic (CD19) and IgG and IgM: v1 (D1), v2 (w2), v3 (w3), v4 (w4), end of study (w28)

    Antidrug antibodies: v1 (D1), v5 (w12), v6 (w20), end of study (w28)
    Evaluación clínica de la enfermedad y muestras de farmacocinética: v1 (D1), v2 (sem.2), v3 (sem.3), v4 (sem.4), v5 (sem.12), v6 (sem.20), fin del ensayo (sem.28)

    TAC: selección, v5 (sem.12), fin del ensayo (sem.28)

    Biopsia de medula ósea: selección, fin del ensayo (sem.28)

    Bioquímica Sérica & Hematología: selección, v1 (D1), v2 (sem.2), v3 (sem.3), v4 (sem.4), v5 (sem.12), v6 (sem.20), fin del ensayo (sem.28)
    Farmacodinámica (CD19) y IgG y IgM: v1 (D1), v2 (sem.2), v3 (sem.3), v4 (sem.4), fin del ensayo (sem.28)

    Anticuerpos contra el fármaco: v1 (D1), v5 (sem. 12), v6 (sem.20), fin del ensayo (sem.28)
    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 Yes
    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
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    Belarus
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Japan
    Mexico
    New Zealand
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    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
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 122
    F.4.2.2In the whole clinical trial 250
    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)
    None
    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 Decision2014-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-28
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