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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-002169-21
    Sponsor's Protocol Code Number:CP40563
    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:2018-09-17
    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 number2018-002169-21
    A.3Full title of the trial
    A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE (OSELTAMIVIR)-CONTROLLED STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF BALOXAVIR MARBOXIL IN OTHERWISE HEALTHY PEDIATRIC PATIENTS 1 TO <12 YEARS OF AGE WITH INFLUENZA-LIKE SYMPTOMS
    Estudio multicéntrico, aleatorizado, doble ciego y controlado con producto activo (oseltamivir) para evaluar la seguridad, la farmacocinética y la eficacia de baloxavir marboxil en pacientes pediátricos por lo demás sanos de 1 a < 12 años de edad con síntomas seudogripales
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age with Influenza-Like Symptoms
    Estudio para evaluar la seguridad, la farmacocinética y la eficacia de baloxavir marboxil en pacientes pediátricos por lo demás sanos de 1 a < 12 años de edad con síntomas seudogripales
    A.4.1Sponsor's protocol code numberCP40563
    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 SponsorRoche Farma SA que realiza un el ensayo en España y que actúa como representante de F. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. 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 number913257300
    B.5.6E-mailspain.start_up_unit@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 nameBaloxavir marboxil
    D.3.2Product code RO7191686/F08
    D.3.4Pharmaceutical form Granules for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBALOXAVIR MARBOXIL
    D.3.9.2Current sponsor codeRO7191686
    D.3.9.3Other descriptive nameS-033188
    D.3.9.4EV Substance CodeSUB190816
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.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 Tamiflu
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH, Germany
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code Ro 64-0796/V36
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOSELTAMIVIR
    D.3.9.1CAS number 196618-13-0
    D.3.9.2Current sponsor codeRO0640796
    D.3.9.4EV Substance CodeSUB03553MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboGranules for oral suspension
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Influenza
    Influenza
    E.1.1.1Medical condition in easily understood language
    Influenza, commonly known as "the flu", is an infectious respiratory disease caused by influenza viruses.
    Influenza comúnmente conocida como la gripe, es una enfermedad respiratoria causada por el virus del influenza
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10022003
    E.1.2Term Influenza B virus infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    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 20.0
    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 compare the safety of a single dose of baloxavir marboxil with 5 days of oseltamivir administered twice daily
    Comparar la seguridad de una dosis única de baloxavir marboxil con la de oseltamivir administrado dos veces al día durante 5 días
    E.2.2Secondary objectives of the trial
    • To evaluate the PK of baloxavir marboxil and baloxavir after single dose of baloxavir marboxil
    • To evaluate the clinical efficacy of baloxavir marboxil compared with oseltamivir
    • To evaluate the antiviral activity of baloxavir marboxil compared with oseltamivir
    Evaluar la farmacocinética de baloxavir marboxil después de la administración de una dosis única
    Evaluar la eficacia clínica de baloxavir marboxil en comparación con oseltamivir
    Evaluar la eficacia clínica de baloxavir marboxil en comparación con oseltamivir
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged 1 to < 12 years at randomization (Day 1)
    - Parent/guardian willing and able to comply with study requirements, in the investigator’s judgment
    - Patient able to comply with study requirements, depending on the patient’s level of understanding
    - Patient with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
    ● Fever >=38 degrees C (tympanic temperature) at screening
    ● At least one respiratory symptom (either cough or nasal congestion)
    - The time interval between the onset of symptoms and screening is <= 48 hours (the onset of symptoms is defined as the time when body temperature first exceeded 37.5 degrees C if known, or the time when the first symptom was noticed by patient, parent or caregiver)
    Edad de 1 a < 12 años en el momento de la aleatorización (día 1).
    Disposición y capacidad de los padres o el tutor para cumplir los requisitos del estudio, a criterio del investigador.
    Capacidad del paciente para cumplir los requisitos del estudio, dependiendo de su nivel de comprensión.
    Paciente con diagnóstico de infección por el virus de la gripe confirmada por la presencia de todo lo siguiente:
     Fiebre ≥ 38 C (temperatura timpánica) en la visita de selección.
     Al menos un síntoma respiratorio (tos o congestión nasal).
    El intervalo entre el comienzo de los síntomas y la selección es ≤ 48 horas (el comienzo de los síntomas se define como el momento en que la temperatura corporal superó por primera vez los 37,5 C, si se conoce, o el momento en que el paciente, sus padres o su cuidador percibieron el primer síntoma).
    E.4Principal exclusion criteria
    - Severe symptoms of influenza virus infection requiring inpatient treatment
    - Concurrent infections requiring systemic antiviral therapy at screening
    - Require, in the opinion of the investigator, any of the prohibited medication during the study
    - Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening
    - Immunization with a live/attenuated influenza vaccine in the 2 weeks prior to randomization
    - Concomitant treatment with steroids or other immuno-suppressant therapy
    - Known HIV infection or other immunosuppressive disorder
    - Uncontrolled renal, vascular, neurologic, or metabolic disease (e.g., diabetes, thyroid disorders, adrenal disease), hepatitis, cirrhosis, or pulmonary disease or patients with known chronic renal failure
    - Active cancer at any site
    - History of organ transplantation
    - Known allergy to either study drug (i.e., baloxavir marboxil and oseltamivir) or to acetaminophen
    - Females who have commenced menarche (i.e., child-bearing potential)
    - Participation in a clinical trial within 4 weeks or 5 half-lives of exposure to an investigational drug prior to screening, whichever is longer
    Los pacientes que cumplan alguno de los criterios siguientes no podrán participar en el estudio:
    Síntomas intensos de infección por el virus de la gripe con necesidad de tratamiento hospitalario.
    Infecciones concurrentes con necesidad de tratamiento antiviral sistémico en la fase de selección.
    Necesidad, en opinión del investigador, de cualquiera de los medicamentos prohibidos durante el estudio.
    Tratamiento previo con peramivir, laninamivir, oseltamivir, zanamivir o amantadina en las dos semanas previas a la selección.
    Vacunación con una vacuna antigripal de virus vivos/atenuados en las dos semanas previas a la aleatorización.
    Tratamiento concomitante con esteroides u otros inmunodepresores.
    Infección conocida por el VIH u otro trastorno inmunodepresor.
    Enfermedad renal, vascular, neurológica o metabólica no controlada (p. ej., diabetes, trastornos tiroideos, enfermedad suprarrenal), hepatitis, cirrosis o neumopatía o pacientes con insuficiencia renal crónica conocida.
    Cáncer activo en cualquier localización.
    Antecedentes de trasplante de órganos.
    Alergia conocida a cualquiera de los fármacos del estudio (es decir, baloxavir marboxil y oseltamivir) o a paracetamol.
    Mujeres que hayan tenido la menarquia (es decir, en edad fértil).
    Participación en un ensayo clínico en las 4 semanas, o el equivalente a 5 semividas de exposición a un fármaco en investigación, previas a la selección, lo que suponga más tiempo.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence, severity, and timing of adverse events, serious adverse events, vital sign measurements, and clinical laboratory test results
    Incidencia, intensidad y cronología de los acontecimientos adversos, acontecimientos adversos graves, determinaciones de constantes vitales y resultados de los análisis clínicos
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to Day 29
    Hasta el día 29
    E.5.2Secondary end point(s)
    PK Endpoints
    1. Plasma concentrations of baloxavir marboxil (pro-drug) and S-033447 (active metabolite) will be summarized by time (C24 and C72) and body weight
    2. Area under the concentration-time curve from Time 0 to infinity (AUCinf) of baloxavir
    3. Maximum plasma concentration (Cmax) of baloxavir
    4. Time to maximum plasma concentration (Tmax) of baloxavir
    5. Half-life (t1/2) of baloxavir
    Secondary efficacy Endpoints
    6. Time to alleviation of influenza signs, symptoms
    7. Time to return to normal health and activity
    8. Duration of fever
    9. Duration of symptoms
    10. Frequency of influenza-related complications
    11. Proportion of patients requiring antibiotics
    Virology Endpoints
    12. Time to cessation of viral shedding by virus titer and by reverse transcriptase-polymerase chain reaction (RT-PCR)
    13. Change from baseline in influenza virus titer and in the amount of virus RNA (RT-PCR) at each time point
    14. Proportion of patients with positive influenza virus titer and proportion of patients positive by RT-PCR at each time point
    15. Area under the curve in virus titer and in the amount of virus RNA (RT-PCR)
    Se resumirán las concentraciones plasmáticas de baloxavir marboxil (profármaco) y S-033447 (metabolito activo) en función del tiempo (C24 y C72) y
    el peso corporal
    Parámetros derivados de un modelo de farmacocinética poblacional (p. ej., AUCinf, Cmáx, Tmáx, t1/2) (informe de modelización)
    Tiempo transcurrido hasta el alivio de los signos y síntomas gripales, definido como el tiempo transcurrido entre el comienzo del tratamiento y el momento en que se cumplan todos los criterios siguientes y manteniéndose así durante al menos 21,5 horas
    Duración de la fiebre (tiempo transcurrido hasta el retorno a un estado afebril [temperatura timpánica ≤ 37,2 C], manteniéndose así durante al menos 21,5 horas)
    Duración de los síntomas (alivio de todos los síntomas, definido por una puntuación de 0 [sin problemas] o 1 [problema leve], manteniéndose así durante al menos 21,5 horas, en relación con los 18 síntomas especificados en el cuestionario CARIFS)
    Tiempo transcurrido hasta la recuperación de una salud y actividad normales
    Frecuencia de complicaciones relacionadas con la gripe (muerte, hospitalización, neumonía confirmada radiológicamente, bronquitis, sinusitis, otitis media, encefalitis/encefalopatía, convulsiones febriles, miositis)
    Proporción de pacientes con necesidad de antibióticos
    Tiempo transcurrido hasta el cese de la diseminación viral según el título de virus y por RT-PCR
    Variación con respecto al momento basal del título del virus de la gripe y de la cantidad de ARN del virus (RTPCR) en cada momento de evaluación.
    Proporción de pacientes con título positivo de virus de la gripe y proporción de pacientes con positividad por RT-PCR en cada momento de evaluación
    Área bajo la curva de título del virus y de cantidad de ARN del virus (RT-PCR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-5. Up to day 10
    6-8. Days 1 to 15
    9-15. Up to Day 29
    1 - 5 Hasta el día 10
    6-8 Dias 1 al 15
    9-15 Hasta el dia 29
    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 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) 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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Costa Rica
    Israel
    Mexico
    Panama
    Poland
    South Africa
    Spain
    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
    The end of this study is defined as the date when the last patient, last visit (LPLV) occurs or the date at which the last data point required for statistical analysis or safety follow-up is received from the last patient, whichever occurs later.
    El final de este estudio se define como la fecha en que se produzca la última visita del último paciente o la fecha en la que se reciban los últimos datos necesarios para los análisis estadísticos o el seguimiento de la seguridad del último paciente, lo que ocurra más tarde.
    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 months8
    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 months8
    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 Yes
    F.1.1Number of subjects for this age range: 120
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 110
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric patients with influenza-like symptoms
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 120
    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)
    Currently, the Sponsor does not have any plans to provide the Roche IMPs (baloxavir marboxil or oseltamivir) or any other study treatments or interventions to patients who have completed the study.
    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 Decision2018-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-03
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