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    Summary
    EudraCT Number:2016-000425-40
    Sponsor's Protocol Code Number:GV29893
    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:2016-06-06
    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 number2016-000425-40
    A.3Full title of the trial
    A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MHAA4549A, A MONOCLONAL ANTIBODY, ADMINISTERED AS MONOTHERAPY FOR THE TREATMENT OF ACUTE UNCOMPLICATED SEASONAL INFLUENZA A INFECTION IN OTHERWISE HEALTHY ADULTS
    ENSAYO DE FASE 2, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE MHAA4549A, UN ANTICUERPO MONOCLONAL, ADMINISTRADO EN MONOTERAPIA PARA EL TRATAMIENTO DE LA INFECCIÓN AGUDA Y NO COMPLICADA POR LA GRIPE A ESTACIONAL EN ADULTOS POR LO DEMÁS SANOS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults
    Un estudio de MHAA4549A como monoterapia para gripe A estacional aguda no complicada en adultos sanos
    A.4.1Sponsor's protocol code numberGV29893
    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 SponsorGenentech 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 supportGENENTECH, Inc. c/o F.Hoffmann-La Roche Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGENENTECH, Inc. c/o F.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameMHAA4549A
    D.3.2Product code MHAA4549A/RO6876802
    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 INNn.a.
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codeMHAA4549A/RO6876802
    D.3.9.3Other descriptive name[anti-Influenza A, 39.29]
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 typeRecombinant human monoclonal immunoglobulin G1 (IgG1) antibody
    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 placeboSolution 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
    acute uncomplicated seasonal influenza
    gripe estacional aguda no complicada
    E.1.1.1Medical condition in easily understood language
    Flu treatment
    Tratamiento para la 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.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10022001
    E.1.2Term Influenza (epidemic)
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10016790
    E.1.2Term Flu
    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
    To evaluate the safety and tolerability of a single IV dose of MHAA4549A as compared to placebo when administered in otherwise healthy patients with acute uncomplicated seasonal influenza A, focusing on the following:
    •Nature, frequency, and severity of serious and non-serious adverse events
    •Effects on laboratory values, vital signs, ECG parameters, and other safety biomarkers
    Evaluar la seguridad y tolerabilidad de una dosis intravenosa (IV) única de MHAA4549A en comparación con placebo cuando se administra a pacientes por lo demás sanos con gripe A estacional aguda y no complicada, centrándose en lo siguiente:
    - Naturaleza, frecuencia e intensidad de los acontecimientos adversos graves y no graves.
    - Efectos sobre los valores analíticos, las constantes vitales, los parámetros del ECG y otros biomarcadores de la seguridad
    E.2.2Secondary objectives of the trial
    To examine the time to alleviation of clinical signs and symptoms of influenza A
    infection
    • To examine the severity of clinical signs and symptoms of influenza A infection
    • To measure hospital admission rate
    • To measure duration of hospital stay
    • To measure antibiotic usage for secondary bacterial respiratory infections
    • To measure the frequency, severity and development of secondary complications of influenza (pneumonia, exacerbation of chronic lung disease, myocarditis, acute respiratory distress syndrome, acute otitis media, other related complications)
    • To measure the incidence of death
    • To measure influenza re-infection rate
    Estudiar el tiempo hasta el alivio de los síntomas y signos clínicos de la infección por la gripe A
    Estudiar la intensidad de los síntomas y signos clínicos de la infección por la gripe A.
    - Determinar la tasa de ingresos hospitalarios.
    - Determinar la duración de la estancia hospitalaria.
    - Medir el uso de antibióticos por infecciones respiratorias bacterianas secundarias.
    - Medir la frecuencia, la intensidad y el desarrollo de complicaciones secundarias de la gripe (neumonía, exacerbación de la enfermedad pulmonar crónica, miocarditis, síndrome de dificultad respiratoria aguda, otitis media aguda, otras complicaciones relacionadas).
    - Determinar la incidencia de muertes.
    - Determinar la tasa de reinfección por la gripe.
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    NA
    E.3Principal inclusion criteria
    •Otherwise healthy adults
    •Positive test for influenza A infection
    •No more than 3 days elapsed between onset of influenza-like illness and start of study drug
    •Presence of at least one moderate or severe constitutional symptom such as headache, myalgia, fever, chills, fatigue, anorexia, or nausea PLUS one moderate or severe respiratory symptom such as cough, sore throat, or rhinorrhea
    •For women of childbearing potential: negative pregnancy test and agreement to use acceptable contraceptive methods for at least 120 days after study drug administration
    •For men: agreement to use acceptable contraceptive methods for at least 30 days after study drug administration
    - adultos por lo demás sanos
    - Resultado positivo para la infección por la gripe A
    - Transcurso de no más de 3días entre el inicio del cuadro gripal y el comienzo del tratamiento del estudio.
    - Presencia de al menos un síntoma general moderado o intenso (por ejemplo, cefalea, mialgias, fiebre, escalofríos, cansancio, anorexia o náuseas) y un síntoma respiratorio moderado o intenso (por ejemplo, tos, dolor de garganta o rinorrea).
    - Mujeres en edad fértil: negativo en una prueba de embarazo y compromiso de uso de métodos aceptables durante al menos 120 días después de la última dosis del fármaco del estudio.
    - Varones: compromiso de uso de métodos anticonceptivos durante al menos 30 los días siguientes a la administración del fármaco
    E.4Principal exclusion criteria
    •Creatinine clearance less than or equal to (</=) 80 milliliters per minute (mL/min)
    •Any significant medical conditions or laboratory abnormalities
    •Clinical signs and symptoms consistent with otitis, bronchitis, sinusitis, or pneumonia or active bacterial infection
    •Use of antiviral therapy in the period from onset of influenza-like illness and prior to enrolment
    •Patients who are currently pregnant, breastfeeding, or have a positive pregnancy test at screening, or are intending to become pregnant during the study
    •Investigational therapy within 30 days or 5 half-lives prior to start of study drug, whichever is greater
    •Prior anti-influenza monoclonal antibody use
    •Receipt of a nasal influenza A vaccine within 14 days prior to Screening
    •Positive test for influenza B or influenza A+B within 2 weeks prior to study drug
    •History of significant tobacco use or drug/alcohol abuse
    •Chronic use of oral or inhaled corticosteroids within 30 days prior to Screening
    •Autoimmune disease, known immunodeficiency of any cause, or use of immunosuppressive medications
    •History of any chronic respiratory condition
    •Human immunodeficiency virus (HIV) with cluster of differentiation (CD) 4 count </= 200 cells per milliliter (cells/mL) in the past 12 months
    •Serious infection requiring oral or intravenous (IV) antibiotics within 14 days prior to Screening
    - Aclaramiento de creatinina menor o igual (<=) a 80 mililitros por minuto (ml/min).
    - Alguna condición médica significativa o cualquier anomalía en las prueba analíticas.
    - Síntomas y signos clínicos compatibles con otitis, bronquitis, sinusitis o neumonía o infección bacteriana.
    - Pacientes que hayan tomado tratamiento antiviral contra la gripe en el período comprendido entre el inicio del cuadro gripal y el momento previo al reclutamiento.
    - Pacientes que estén embarazadas o en período de lactancia o hayan dado positivo en una prueba de embarazo realizada en la selección, o que tengan previsto quedarse embarazadas durante el estudio.
    - Recepción de un tratamiento en investigación en los 30 días previos al comienzo del tratamiento del estudio o en el período equivalente a 5 semividas del producto en investigación, lo que sea mayor.
    - Tratamiento previo con cualquier anticuerpo monoclonal contra la gripe.
    - Recepción de una vacuna contra la gripe A administrada por vía nasal en los 14 días previos a la selección.
    - Infección positiva por la gripe B o la gripe A + B en las 2 semanas previas al tratamiento del estudio.
    - Antecedentes significativos de consumo de tabaco o antecedentes de alcoholismo.
    - Recepción de dosis crónicas de corticosteroides orales en los 30 días previos a la selección.
    - Antecedentes o indicios de enfermedad autoinmunitaria o inmunodeficiencia conocida de cualquier etiología o uso de medicamentos inmunodepresores.
    - Antecedentos de enfermedad pulmonar crónica.
    - Infección conocida por el VIH con recuento de linfocitos T CD4+ <= 200 células/ml en los últimos 12 meses.
    - Infección grave que haya precisado antibióticos orales o IV en los 14 días previos a laselección.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence, nature, and severity of adverse events and clinical laboratory abnormalities associated with the administration of MHAA4549A to patients with influenza A as measured by changes in vital signs, physical findings, and clinical laboratory results
    Naturaleza, frecuencia e intensidad de los acontecimientos adversos graves y no
    graves asociados con la administración de MHAA4549A a pacientes con gripe A estacional aguda medido en los cambios de las constantes vitales, hallazgos físicos y valores analíticos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to Day 100
    Desde basal a día 100
    E.5.2Secondary end point(s)
    •Time to alleviation of sign/symptoms of influenza A infection as defined by a rating of 1 or less (mild or none) for each symptom on a 4-point symptom scale [ Time Frame: From Baseline to Day 14 ]
    •Percentage of participants requiring hospitalization for influenza-related complications
    •Duration of hospitalization for influenza-related complications
    •Percentage of participants with influenza-related deaths
    •Percentage of participants requiring antibiotics for secondary bacterial infections
    •Percentage of participants with influenza-related complications
    •Percentage of participants with influenza A relapse or reinfection
    •PK measurements in serum (including Cmax, AUC, systemic clearance, volume of distribution, and half-life)
    Estudiar el tiempo hasta el alivio de los síntomas y signos clínicos de la infección por la gripe A definido por una puntuación de 1 o menos (leve o ninguno) para cada síntoma en una escala de 4 puntos para el síntoma [Rango de tiempo: desde basal hasta el día 14]
    - tasa de ingresos hospitalarios debido a complicaciones relacionadas con la gripe.
    - duración de la estancia hospitalaria debido a complicaciones relacionadas con la gripe.
    - Determinar la incidencia de muertes debido a complicaciones relacionadas con la gripe.
    - Medir el uso de antibióticos por infecciones respiratorias bacterianas secundarias.
    - Medir la frecuencia, la intensidad y el desarrollo de complicaciones secundarias de la gripe.
    - Determinar la tasa de reinfección por la gripe
    - Mediciones de PK en el suero (incluyendo Cmax, área bajo la curva (AUC), el aclaramiento sistémico, el volumen de distribución, y semivida)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline to Day 100 unless otherwise noted
    Desde basal hasta el día 100 a menos que se indique lo contrario.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    Korea, Republic of
    Spain
    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
    The end of the study is defined as the first day when all patients have had a study completion visit or early termination visit or have otherwise been discontinued from the study. End of study is defined by last visit of the last subject .
    El final del estudio se define como el primer día en el que todos los pacientes se hayan sometido a la visita de finalización del estudio o de retirada prematura o hayan sido retirados del estudio de otro modo. El final del estudio se define como la última visita del último paciente.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 141
    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)
    Subjects will not require treatment and should not require care for influenza A infection after ending participation in the trial. Per subject preference, he/she will be cared for by his/her primary care provider after ending participation in the trial.
    Los sujetos no requiere un tratamiento y no deben requerir cuidado por la infección por gripe A tras finalizar la participación en el ensayo. Según la preferencia del paciente, él / ella va a ser cuidado por su médico de atención primaria después de terminar la participación en el ensayo.
    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 Decision2016-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-13
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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