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    Summary
    EudraCT Number:2014-005217-24
    Sponsor's Protocol Code Number:GS-US-326-1100
    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:2015-11-10
    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 number2014-005217-24
    A.3Full title of the trial
    A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study
    Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis
    Estudio de fase II/III, doble ciego, aleatorizado y controlado con placebo, para evaluar la seguridad y eficacia del tratamiento de inducción y mantenimiento con GS-5745 en pacientes con colitis ulcerosa activa de moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis
    Estudio de investigación clínica en el que se evaluará la seguridad y eficacia de un medicamento experimental para el tratamiento de la colitis ulcerosa de moderada a grave
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberGS-US-326-1100
    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 SponsorGilead Sciences, 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 supportGilead Sciences Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trial Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34913789830
    B.5.5Fax number+34913789841
    B.5.6E-mailclinical.trials@gilead.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code GS-5745
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGS-5745
    D.3.9.2Current sponsor codeGS-5745
    D.3.9.3Other descriptive nameGS-5745
    D.3.9.4EV Substance CodeSUB119675
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    Colitis ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    Colitis ulcerosa
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 GS-5745 to induce EBS clinical remission at Week 8 (Cohort 1)
    ? To evaluate the efficacy of GS-5745 to maintain EBS clinical remission at Week 52 (Cohort 2)
    ? To evaluate the safety and tolerability of GS-5745
    ? Evaluar la eficacia de GS-5745 para inducir la remisión clínica EBS en la semana 8 (cohorte 1)
    ? Evaluar la eficacia de GS-5745 para mantener la remisión clínica EBS en la semana 52 (cohorte 2)
    ? Evaluar la seguridad y la tolerabilidad de GS-5745
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of GS-5745
    ? induction treatment on achieving MCS defined remission and response at Wk 8 (Cohort 1)
    ? induction and maintenance treatment on both sustained EBS and MCS clinical remission at Wk 52 (EBS clinical remission at both Wk 8 and 52) (Cohort 1)
    ? induction treatment on endoscopic response (subscore 0 or 1) and remission (subscore of 0) at Wk 8; mucosal healing (Geboes histologic scoring) at Wk 8 (Cohort 1)
    ? maintenance treatment on MCS remission at Wk 52 (Coh 2); on achieving corticosteroid-free; EBS clinical remission at Week 52 (Cohort 2); endoscopic remission (subscore of 0) at Wk 52 (Cohort 2); mucosal healing as determined by the Geboes histologic scoring system at Wk 52 (Cohort 2)
    ?To evaluate the efficacy of GS-5745 To assess the PK characteristics of GS-5745 (Cohorts 1 and 2)
    ?To evaluate the efficacy of GS-5745 To evaluate the immunogenicity of GS-5745 treatment as measured by the emergence of anti-drug-antibodies (ADA) (Cohorts 1 and 2)
    Evaluar la eficacia del GS-5745
    ? trat de inducción en la consecución de remisión y respuesta definidas por la escala MCS en la S8 (coh 1)
    ? trat inducción y mant en la remisión clínica de EBS y MSC mantenida en la S52, (def por lograr remisión clínica EBS tanto en la S8 como en la S52) (coh 1)
    ? trat de inducción en la respuesta endos (subpuntuación endos de 0 o 1) y en la remisión (subpuntuación endos a de 0) en la S8 (coh 1),en la curación mucosa según sist de puntuación histológica de Geboes en la S8 (coh 1)
    ?Mant en la remisión MCS en la S52 (coh 2),en la consecución de remisión clínica EBS sin corticosteroides en la S52 (coh 2),en la remisión endos (subpuntuación endos de 0) en la S52 (coh 2), en la curación mucosa según sistema de puntuación histológica de Geboes en la S52 (cohorte 2),
    ?Evaluar las características FC de GS-5745 (coh 1 y 2)
    ?Evaluar la inmunogenia del tratamiento con GS-5745, medida según la aparición de anticuerpos contra el fármaco (ACF) (coh 1 y 2)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic (PK) Substudy
    For PK sub-study, primary PK parameters will include Cmax, Tmax, Clast, Tlast, and AUClast,will be measured as applicable
    Subestudio Farmacocinético FC
    For PK sub-study, primary PK parameters will include Cmax, Tmax, Clast, Tlast, and AUClast,will be measured as applicable
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
    1) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
    2) Males or females (non-pregnant, non-lactating), ages 18 to 75 years, inclusive based on the date of the screening visit
    3) Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge
    4) A surveillance colonoscopy is required at screening in subjects with a history of ulcerative colitis for 8 or more years, if one was not performed in the prior 24 months
    5) Moderately to severely active UC as determined by a centrally read endoscopy score ? 2, a rectal bleeding score ? 1, a stool frequency score ? 1 and PGA of 2 or 3as determined by the Mayo clinical scoring system with endoscopy occurring within 14 days to first dose of study drug
    6) Demonstrated at any time over the prior 5 years, an inadequate clinical response or loss of response to, or intolerance of at least one of the following agents:
    - Corticosteroids
    - Immunomodulators
    - TNF? Antagonists
    - Vedolizumab
    7) May be receiving the following drugs:
    ? Oral 5-ASA compounds provided the dose has been stable for at least 2 weeks prior to screening, and/or
    ? Oral corticosteroid therapy (prednisone at a stable dose ? 30 mg/day or equivalent) provided the dose has been stable for 2 weeks prior to screening, and/or
    ? Azathioprine or 6-MP or methotrexate provided the dose has been stable for 8 weeks prior to screening
    8) Females of childbearing potential (as defined in the protocol) must have a negative pregnancy test at screening and baseline.
    9) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as defined in the protocol
    Los pacientes serán aptos si cumplen todos los criterios de inclusión siguientes:
    1)Deben ser capaces de comprender y firmar un formulario de consentimiento informado por escrito, que se obtendrá antes de iniciar los procedimientos del estudio
    2)Hombres o mujeres (ni embarazadas ni en periodo de lactancia), con edad entre 18 y 75 años, ambos inclusive, según la fecha de la visita de selección
    3)Diagnóstico documentado de CU de 6 meses como mínimo Y extensión mínima de la enfermedad de 15 cm desde el margen externo del ano
    4)Los pacientes con historial de colitis ulcerosa durante 8 años o más deberán someterse a una colonoscopia de vigilancia en la selección, si no se han sometido a ninguna en los últimos 24 meses
    5)CU activa de moderada a intensa, según lo definido por una puntuación endoscópica ? 2 interpretada a nivel central, una puntuación de rectorragia ? 1, una puntuación de frecuencia de deposiciones ? 1 y una PGA de 2 o 3, según lo definido por el sistema de puntuación de la clínica Mayo; la endoscopia debe haberse efectuado en el plazo de los 14 días anteriores a la primera dosis del fármaco de estudio
    6)Respuesta clínica insuficiente, o pérdida de la respuesta o intolerancia a como mínimo uno de los fármacos siguientes, demostrada en cualquier momento de los últimos 5 años:
    ?Corticosteroides
    ?Inmunomoduladores
    ?Antagonistas del TNF?
    ?Vedolizumab
    7)Pueden recibir alguno de los fármacos siguientes:
    ?Compuestos con 5-ASA por vía oral siempre que la dosis se haya mantenido estable durante como mínimo las 2 semanas anteriores a la selección, y/o
    ?Tratamiento con corticosteroides por vía oral (prednisona a una dosis estable ? 30 mg/día o equivalente), siempre que la dosis se haya mantenido estable durante las 2 semanas anteriores a la selección, y/o
    ?Azatioprina o 6-MP o metotrexato siempre que la dosis se haya mantenido estable durante las 8 semanas anteriores a la selección
    8)Las mujeres en edad fértil (consulte la definición en el apéndice 7) deben presentar una prueba de embarazo negativa en la selección y en el inicio.
    9)Los pacientes, tanto varones como mujeres, que estén en edad fértil y mantengan relaciones heterosexuales deben comprometerse a utilizar métodos anticonceptivos especificados en el protocolo, tal y como se describe en el apéndice 7.
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
    1) Known hypersensitivity to the study investigational medicinal products
    2) Exhibit severe UC as definedin the protocol:
    3) Laboratory parameters:
    ? Liver panel (AST, ALT, total bilirubin, alkaline phosphatase) > 3 times the ULN
    ? Serum creatinine > 2 times the ULN
    ? Hemoglobin < 8 g/dL (both males and females)
    ? Absolute neutrophil count (ANC) < 1.5 × 109/L (1,500 mm3)
    ? Platelets < 100 × 109/L
    4) Use of rectal formulations of 5-ASA compounds or corticosteroids 2 weeks prior to screening
    5) Crohn?s disease or indeterminate colitis
    6) History of colectomy, partial colectomy, or dysplasia on biopsy
    7) History of colonic or small bowel stoma
    8) Stool sample positive for clostridium difficile (C. difficile) toxin, Escherichia coli, Salmonella, Shigella, Campylobacter or Yersinia
    9) Stool positive for ova and parasites test (O&P) unless approved by the medical monitor
    10) Treatment with infliximab, adalimumab, natalizumab, golimumab, vedolizumab, certolizumab, or TNF? biosimilar agent 4 weeks prior to screening (and last dose must be at least 8 weeks prior to randomization)
    11) Treatment with non-biologic therapies (eg, cyclosporine, thalidomide) other than those permitted in Section 5.4 at least 4 weeks prior to screening
    12) Other clinically significant active infection
    13) Chronic medical or psychiatric problem that may interfere with subject?s ability to comply with study procedures
    14) Co-infection with chronic HIV, hepatitis B or hepatitis C
    15) Active tuberculosis or history of latent tuberculosis that has not been treated
    16) History of malignancy in the last 5 years except for subjects who have been successfully treated for non-melanoma skin cancer or cervical carcinoma in situ
    17) Any other investigational therapy or investigational biologics use 4 weeks prior to screening (and at least 8 weeks prior to randomization)
    18) Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol
    19) Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and up to 30 days of the last dose of the study drug
    20) Male subjects unwilling to refrain from sperm donation 90 days after the last dose of study drug
    21) Treatment with tacrolimus
    22) Treatment with apheresis therapy
    Los pacientes no serán aptos si cumplen alguno de los criterios de exclusión siguientes:
    1)Hipersensibilidad conocida a los productos en investigación del estudio
    2)Presentan CU intensa, definida por los criterios siguientes:
    ?? 6 deposiciones hemorrágicas diarias Y uno o más de los puntos siguientes:
    Temperatura bucal > 38 °C (o 100,3 °F)
    Pulso > 90 pulsaciones/minuto
    3)Parámetros de laboratorio:
    ?Pruebas hepáticas (AST, ALT, bilirrubina total, fosfatasa alcalina) > 3 veces el LSN
    ?Creatinina sérica > 2 veces el LSN
    ?Hemoglobina < 8 g/dl (tanto hombres como mujeres)
    ?Recuento absoluto de neutrófilos (RAN) < 1,5 x 109/l (1500/mm3)
    ?Plaquetas < 100 × 109/l
    4)Uso de formulaciones rectales con compuestos de 5-ASA o corticosteroides 2 semanas antes de la selección
    5)Enfermedad de Crohn o colitis indeterminada
    6)Antecedentes de colectomía, colectomía parcial o displasia en la biopsia
    7)Antecedentes de estoma colónico o de intestino delgado
    8)Muestra de deposiciones con resultado positivo para la toxina de Clostridium difficile (C. difficile), Escherichia coli, Salmonella, Shigella, Campylobacter o Yersinia
    9)Muestra de deposiciones con resultado positivo para la prueba de huevos y parásitos (O&P), excepto si lo autoriza el monitor clínico
    10)Tratamiento con infliximab, adalimumab, natalizumab, golimumab, vedolizumab, certolizumab o biosimilares de TNF? 4 semanas antes de la selección (y la última dosis debe haberse administrado como mínimo 8 semanas antes de la aleatorización)
    11)Tratamiento con fármacos no biológicos (p. ej., ciclosporina, talidomida) diferentes de los permitidos en el apartado 5.4 como mínimo 4 semanas antes de la selección
    12)Otra infección activa clínicamente significativa
    13)Problema crónico médico o psiquiátrico que pudiera interferir en la capacidad del paciente para cumplir los procedimientos del estudio
    14)Coinfección con VIH, hepatitis B o hepatitis C crónicas
    15)Tuberculosis activa o antecedentes de tuberculosis latente que no se ha tratado
    16)Antecedentes de neoplasias malignas en los últimos 5 años excepto en pacientes con tratamiento satisfactorio del cáncer de piel no melanoma o carcinoma de cuello uterino in situ
    17)Uso de otros tratamientos en investigación o biológicos en investigación 4 semanas antes de la selección (y como mínimo 8 semanas antes de la aleatorización)
    18)Cualquier enfermedad crónica (incluyendo, entre otras, cardiopatía o neumopatía, alcoholismo o toxicomanía), que a juicio del investigador convertiría al paciente en no apto para participar en el estudio u obstaculizaría el cumplimiento de los procedimientos del protocolo del estudio
    19)Mujeres con intención de quedarse embarazadas y/o que tengan prevista la donación o recuperación de óvulos con el propósito de fecundaciones en el momento o en el futuro durante el transcurso del estudio y hasta 30 días después de la última dosis del fármaco de estudio
    20)Pacientes del sexo masculino reticentes a abstenerse de donar esperma durante como mínimo los 90 días posteriores a la última dosis del fármaco de estudio
    21) Tratamiento con tacrolimús
    22) Tratamiento con aféresis
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for Cohort 1 is:
    ? Proportion of subjects achieving EBS clinical remission at Week 8

    The primary efficacy endpoint for Cohort 2 is:
    ? Proportion of subjects achieving EBS clinical remission at Week 52
    El criterio principal de valoración de la cohorte 1 es:

    ? Proporción de pacientes que consigan remisión clínica EBS en la semana 8
    El criterio principal de valoración de la cohorte 2 es:
    ? Proporción de pacientes que consigan remisión clínica EBS en la semana 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8 or Week 52
    Semana 8 o Semana 52
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints for Cohort 1 are:
    ? Proportion of subjects achieving MCS remission at Week 8
    ? Proportion of subjects achieving MCS response at Week 8
    ? Proportion of subjects achieving sustained EBS clinical remission at Week 52 (defined as achieving EBS clinical remission at both Week 8 and Week 52)
    ? Proportion of subjects achieving sustained MCS clinical remission at Week 52 (defined as achieving MCS clinical remission at both Week 8 and Week 52)
    ? Proportion of subjects achieving endoscopic remission (endoscopic subscore of 0) at Week 8
    ? Proportion of subjects achieving endoscopic response (endoscopic subscore 0 or 1) at Week 8
    ? Proportion of subjects achieving mucosal healing as determined by the Geboes histologic scoring system at Week 8
    ? Proportion of subjects achieving remission as defined by MCS remission (alternative definition) at Week 8

    The secondary efficacy endpoints for Cohort 2 are:
    ? Proportion of subjects achieving MCS remission at Week 52
    ? Proportion of subjects achieving corticosteroid-free EBS clinical remission at Week 52
    ? Proportion of subjects achieving endoscopic remission (endoscopic subscore of 0) at Week 52
    ? Proportion of subjects achieving mucosal healing as determined by the Geboes histologic scoring system at Week 52
    ? Proportion of subjects achieving remission as defined by MCS remission (alternative definition) at Week 52
    ? Proportion of subjects achieving corticosteroid-free EBS clinical remission for at least 24 weeks prior to Week 52
    Los criterios secundarios de valoración de la eficacia de la cohorte 1 son:

    ?Proporción de pacientes que consigan remisión MCS en la semana 8
    ?Proporción de pacientes que consigan respuesta MCS en la semana 8
    ?Proporción de pacientes que consigan remisión clínica EBS mantenida en la semana 52 (definida por conseguir remisión clínica EBS tanto en la semana 8 como en la semana 52)
    ?Proporción de pacientes que consigan remisión clínica MCS mantenida en la semana 52 (definida por conseguir remisión clínica MCS tanto en la semana 8 como en la semana 52)
    ?Proporción de pacientes que consigan remisión endoscópica (subpuntuación endoscópica de 0) en la semana 8
    ?Proporción de pacientes que consigan respuesta endoscópica (subpuntuación endoscópica de 0 o 1) en la semana 8
    ?Proporción de pacientes que consigan curación mucosa según lo determinado por el sistema de puntuación histológica de Geboes en la semana 8
    ?Proporción de pacientes que consigan remisión definida por la remisión MCS (definición alternativa) en la semana 8

    Los criterios secundarios de valoración de la eficacia de la cohorte 2 son:
    ? Proporción de pacientes que consigan remisión MCS en la semana 52
    ? Proporción de pacientes que consigan remisión clínica EBS sin corticosteroides en la semana 52
    ? Proporción de pacientes que consigan remisión endoscópica (subpuntuación endoscópica de 0) en la semana 52
    ? Proporción de pacientes que consigan curación mucosa según lo determinado por el sistema de puntuación histológica de Geboes en la semana 52
    ? Proporción de pacientes que consigan remisión definida por la remisión MCS (definición alternativa) en la semana 52
    ? Proporción de pacientes que consigan remisión clínica EBS sin corticosteroides durante al menos 24 semanas antes de la semana 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 8 and/or Week 52
    Semana 6 y/o Semana 52
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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) Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA175
    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
    Brazil
    Bulgaria
    Canada
    Colombia
    Croatia
    Czech Republic
    Hong Kong
    India
    Iran, Islamic Republic of
    Israel
    Korea, Republic of
    Malaysia
    Mexico
    Moldova, Republic of
    New Zealand
    Philippines
    Romania
    Slovakia
    Slovenia
    South Africa
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United States
    Vietnam
    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 subject last visit
    Última visita de último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months7
    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: 1440
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 875
    F.4.2.2In the whole clinical trial 1600
    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 a patient has completed/terminated their study participation, long term care for the participant will remain the responsibility of their primary treating physicians.
    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 Decision2016-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
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