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    Summary
    EudraCT Number:2015-004276-29
    Sponsor's Protocol Code Number:D6000C00003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-08-23
    Trial 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 number2015-004276-29
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-blind, Single-dose, Active-controlled,
    Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in
    Adults who are Hospitalized with Influenza Caused by Type A Strains
    Estudio de fase IIb, aleatorizado, doble ciego, de dosis única, controlado con comparador activo y de búsqueda de dosis para evaluar la eficacia y la seguridad de MEDI8852 en adultos hospitalizados con gripe causada por cepas de tipo A
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2b Study to Evaluate the Efficacy and Safety of MEDI8852 in
    Adults who are Hospitalized with Influenza
    Estudio de fase IIb para evaluar la eficacia y la seguridad de MEDI8852 en adultos hospitalizados con gripe
    A.4.1Sponsor's protocol code numberD6000C00003
    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 SponsorMedImmune, LLC
    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 supportMedImmune, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg, MD
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.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 nameMEDI8852
    D.3.2Product code MEDI8852
    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 assigned
    D.3.9.2Current sponsor codeMEDI8852
    D.3.9.3Other descriptive nameHUMAN IMMUNOGLOBULIN G
    D.3.9.4EV Substance CodeSUB127300
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients hospitalized with influenza caused by Type A strains
    Pacientes hospitalizados con gripe causada por cepas de tipo A
    E.1.1.1Medical condition in easily understood language
    Influenza (flu)
    gripe (gripe)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10022002
    E.1.2Term Influenza A virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the effect of MEDI8852 administered in conjunction with
    oseltamivir and the effect of oseltamivir alone in reducing time to
    normalization of respiratory function
    2. To compare the safety and tolerability of a single intravenous(IV)
    dose of MEDI8852 administered in conjunction with oseltamivir to the
    safety and tolerability of oseltamivir alone
    1. Evaluar el efecto del MEDI8852 administrado en combinación con el oseltamivir y el efecto del oseltamivir en monoterapia en la reducción del tiempo hasta la normalización de la función respiratoria.
    2. Comparar la seguridad y tolerabilidad de una única dosis por vía intravenosa (i. v.) de MEDI8852 administrado en combinación con el oseltamivir con la seguridad y tolerabilidad del oseltamivir en monoterapia.
    E.2.2Secondary objectives of the trial
    To evaluate/determine: 1. the effect of MEDI8852 in reducing severity of clinical status
    2. the effect of MEDI8852 in reducing time to clinical resolution of individual vital sign abnormalities
    3.the effect of MEDI8852 in reducing NEWS
    4.the effect of MEDI8852 in reducing time to hospital discharge
    5.the effect of MEDI8852 in reducing time to ICU discharge
    6.the effect of MEDI8852 in reducing the duration of mechanical ventilation
    7.the effect of MEDI8852 in reducing the rates of ICU admission from the general ward
    8.the effect of MEDI8852 on all-cause mortality
    9.the effect of MEDI8852 on all-cause hospital re-admission rates during the study
    10.the effect of MEDI8852 in reducing the duration and quantity of viral shedding by by quantitative reverse transcriptase (qRT-PCR) over time
    11. To evaluate the serum concentration and PK of MEDI8852
    12. To evaluate the serum ADA of MEDI8852
    Evaluar/determinar el efecto: 1.del MEDI8852 en la reducción de la gravedad del estado clínico
    2.del MEDI8852 en la reducción del tiempo hasta la resolución clínica de determinadas anomalías en las constantes vitales
    3.del MEDI8852 en reducir la NEWS
    4.del MEDI8852 en la reducción del tiempo hasta el alta hospitalaria
    5.del MEDI8852 en la reducción del tiempo hasta el alta de la UCI
    6.del MEDI8852 en la reducción de la duración de la ventilación mecánica
    7.del MEDI8852 en la reducción de las tasas de ingreso en la UCI desde el servicio hospitalario general
    8.del MEDI8852 en la mortalidad por cualquier causa
    9.del MEDI8852 en las tasas de reingreso en el hospital por cualquier causa durante el estudio
    10.el efecto del MEDI8852 en la reducción de la duración y cantidad de la propagación viral a partir de la transcriptasa inversa cuantitativa (qRT-PCR) a lo largo del tiempo
    11. evaluar la concentración sérica y FC del MEDI8852
    12. evaluar los AAF del MEDI8852 en suero
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 years or older at the time of screening.
    2. Written informed consent and any locally required authorization
    obtained from the subject/legal representative prior to performing any
    protocol-related procedures, including screening evaluations.
    3. Females of childbearing potential who are sexually active with a
    nonsterilized male partner must have evidence of not being pregnant
    upon enrollment and have a negative pregnancy test prior to
    administration of investigational product.
    4. Hospitalized ≤ 72 hours prior to receipt of a positive diagnostic test
    for influenza A; confirmed with positive rapid antigen test, or confirmed
    with culture, polymerase chain reaction, or antigen testing at the study
    site.
    5. Onset of influenza symptoms ≤ 144 hours (≤ 6 days) prior to
    randomization.
    6. Receiving supplemental oxygen.
    7. Expected to participate in the study through Day 60.
    1. Mayores de edad en el momento de la selección
    2. Consentimiento informado por escrito y de cualquier autorización requerida en el país obtenida por el sujeto/representante legal antes de realizar cualquier procedimiento relacionados con el protocolo, incluidas las evaluaciones de selección
    3. Mujeres fértiles sexualmente activas con una pareja masculina no esterilizada con evidencia de la inexistencia de embarazo en el momento de la inscripción y tener una prueba negativa de embarazo antes de la
    administración del producto en investigación.
    4. Hospitalizados ≤ 72 horas antes de la recepción de una prueba diagnóstica positiva para la gripe A; confirmada con la prueba rápida del antígeno positivo, o confirmada con el cultivo, la reacción en cadena de la polimerasa, o la prueba de antígenos en el centro de estudio.
    5. Inicio de los síntomas de la gripe ≤ 144 horas (≤ 6 días) antes de randomización
    6. Administración de oxígeno
    7. Se espera que participen en el estudio hasta el día 60
    E.4Principal exclusion criteria
    1. Any condition that, in the opinion of the investigator, would interfere
    with evaluation of study drugs or interpretation of subject safety or
    study results.
    2. Concurrent enrollment in another clinical study involving an
    investigational treatment.
    3. Hospitalized > 72 hours (> 3 days) prior to receipt of a positive
    diagnostic test for influenza A.
    4. Receipt of > 72 hours or > 6 doses of treatment with a neuraminidase (NA) inhibitor.
    5. Receipt of any investigational antiviral medications within 30 days
    prior to study drug dosing.
    6. Previous receipt of an influenza mAb within past 100 days.
    7. Pregnant or nursing female.
    8. History of allergic disease or reactions likely to be exacerbated by any
    components of the study drugs (MEDI8852 or oseltamivir).
    9. Diagnosis of influenza B infection within 14 days prior to
    randomization.
    10. Employees of the sponsor, clinical study site, or any other individuals
    involved with the conduct of the study, or immediate family members of
    such individuals.
    1. Cualquier condición que, en opinión del investigador, interfiera con la evaluación del fármaco del estudio o la interpretación de la seguridad del sujeto o resultados del estudio.
    2. Inscripción simultánea en otro estudio clínico con un tratamiento en investigación.
    3. Hospitalizados > 72 horas (> 3 días) antes de la recepción de una prueba diagnóstica positiva para la gripe A
    4. Administración de > 72 horas o > 6 dosis de tratamiento con un inhibidor de la neuraminidasa (NA).
    5. Administración de cualquier medicamento antiviral en investigación dentro de los 30 días
    anteriores a la dosis del medicamento en investigación.
    6. Administración previa de un anticuerpo monoclonal de la gripe dentro de los últimos 100 días.
    7. mujer embarazada o amamantando.
    8. Antecedentes de enfermedad o reacciones alérgicas que puedan verse exacerbadas por cualquiera de los
    componentes de los fármacos del estudio (MEDI8852 o oseltamivir).
    9. El diagnóstico de infección por gripe B dentro de los 14 días antes de la randomización.
    10. Los empleados del Promotor, del centro de estudio, o cualquier otro individuo
    involucrado en la realización del estudio, o familiares cercanos de dichas personas.
    E.5 End points
    E.5.1Primary end point(s)
    a. Time to normalization of respiratory function, defined as:
    i. For subjects without underlying chronic lung disease and not on supplemental
    oxygen prior to hospitalization, an oxygen saturation of ≥ 95% for 24 hours on room air
    ii. For subjects with underlying chronic lung disease or on supplemental
    oxygen prior to hospitalization, a return to their baseline oxygen
    saturation and/or supplemental oxygen requirements as recorded during
    the 2 months prior to admission and not associated with a concurrent respiratory illness or the
    onset of influenza symptoms for 24 hours

    2. Safety of MEDI8852
    Treatment-emergent serious adverse events (TESAEs) treatment-emergent adverse events (TEAEs) and treatmentemergent adverse events of special interest (TEAESIs)
    a. Tiempo hasta la normalización de la función respiratoria, definido como:
    i. En sujetos sin neumopatía crónica preexistente y sin necesidad de administración de oxígeno antes de la hospitalización, una saturación de oxígeno ≥ 95 % durante 24 horas en aire ambiente.
    ii. En sujetos con neumopatía crónica preexistente o con necesidad de administración de oxígeno antes de la hospitalización, un restablecimiento a las necesidades iniciales de saturación de oxígeno o administración de oxígeno, según lo registrado durante los 2 meses previos al ingreso, y sin estar asociado a una enfermedad respiratoria concurrente o el inicio de los síntomas de la gripe durante 24 horas
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Efficacy of MEDI8852.
    Respiratory function will be followed through Day 14.
    2. Safety of MEDI8852
    a. TEAEs through Day 28
    b. TESAEs and TEAESIs through Day 60
    1. La eficacia de MEDI8852.
    La función respiratoria se seguirá hasta el día 14.
    2. Seguridad de MEDI8852
    a. AAST hasta el día 28
    b. AAGST y AAEIST hasta el día 60
    E.5.2Secondary end point(s)
    1. Ordinal outcome of clinical status
    2. Time to clinical resolution of individual vital signs abnormalities, including temperature, respiration rate, heart rate, and blood pressure
    3. Change in NEWS from baseline to Day 3
    4. Time to hospital discharge
    5. Time to ICU discharge
    6. Duration of mechanical ventilation
    7. Rate of ICU admission from the general ward
    8. All-cause mortality
    9. Rate of all-cause re-admission during the study
    10. Quantification of influenza viral shedding over time by qRT-PCR
    11. MEDI8852 serum concentration and PK parameters
    12. MEDI8852 ADA response in serum
    1. Resultado ordinario del estado clínico
    2. Tiempo hasta la resolución clínica de determinadas anomalías en las constantes vitales, incluida la temperatura, la frecuencia respiratoria, la frecuencia cardíaca y la presión arterial
    3. Cambio en NEWS desde el inicio hasta el día 3
    4. Tiempo hasta el alta hospitalaria
    5. Tiempo hasta el alta de la UCI
    6. Duración de la ventilación mecánica
    7. Tasa de ingreso en la UCI desde el servicio hospitalario general
    8. Mortalidad por cualquier causa
    9. Tasa de reingreso por cualquier causa durante el estudio
    10. Cuantificación de la propagación viral de la gripe a lo largo del tiempo mediante qRT-PCR
    11. Concentración sérica y parámetros FC del MEDI8852
    12. Respuesta de los AAF del MEDI8852 en suero
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 7
    2-11. Followed through Day 60.
    1. Día 7
    2-11. Seguimiento hasta el día 60
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    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 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) 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA98
    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
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Latvia
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Sweden
    Turkey
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 270
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects who are unconscious or considered by the investigator to be
    clinically unable to provide consent at screening and who are entered
    into the study by the consent of a legally acceptable representative
    Los sujetos que están inconscientes o considerados por el investigador como
    clínicamente incapaces de dar su consentimiento en la selección y que entran
    en el estudio con el consentimiento de un representante legal
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adults 60 years of age and older
    Adultos de 60 años de edad en adelante
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 245
    F.4.2.2In the whole clinical trial 450
    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
    Ninguno
    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 Decision2016-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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