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    Summary
    EudraCT Number:2021-001026-22
    Sponsor's Protocol Code Number:1813T0835
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-03-05
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2021-001026-22
    A.3Full title of the trial
    An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Baloxavir Marboxil 2% Granules after Administration of a Single Dose to Otherwise Healthy Pediatric Patients with Influenza
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This Study Will Evaluate the Safety, Tolerability, Activity of the Drug in the Body and Effectiveness of Baloxavir Marboxil Given as Granules in a Single Dose to Otherwise Healthy Children with Influenza
    A.4.1Sponsor's protocol code number1813T0835
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/029/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShionogi & Co., Ltd.
    B.1.3.4CountryJapan
    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 supportShionogi & Co., Ltd.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShionogi & Co., Ltd.
    B.5.2Functional name of contact pointCorporate Communications Department
    B.5.3 Address:
    B.5.3.1Street Address12F, Hankyu Terminal Bldg., 1-4, Shibata 1-chome
    B.5.3.2Town/ cityOsaka
    B.5.3.3Post code530-0012
    B.5.3.4CountryJapan
    B.5.6E-mailshionogiclintrials-admin@shionogi.co.jp
    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 Yes
    D.2.1.1.1Trade name Xofluza
    D.2.1.1.2Name of the Marketing Authorisation holderShionogi & Co., Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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.3.4Pharmaceutical form Granules in sachet
    D.3.4.1Specific paediatric formulation Yes
    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 codeS-033188
    D.3.9.3Other descriptive nameRO7191686
    D.3.9.4EV Substance CodeSUB190816
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Influenza
    E.1.1.1Medical condition in easily understood language
    Flu
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the efficacy of baloxavir marboxil 2% granules in otherwise healthy pediatric subjects weighing less than 20 kg with influenza virus infection.
    - To assess the safety and tolerability of a single dose of baloxavir marboxil 2% granules in pediatric patients weighing less than 20 kg.
    -To assess the pharmacokinetics (PK) of S-033447, the active form of S-033188 (baloxavir marboxil), after single dose administration of baloxavir marboxil 2% granules in pediatric patients weighing less than 20 kg.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients whose body weight at Screening is less than 20 kg and aged less than 12 years when informed consent obtained from the patient’s parent/legally acceptable representative and/or informed assent obtained, as appropriate to the age of patient. If the patient is younger than 1 year of age, he/she had to have body weight no less than 2500 g at birth.
    - Patients with a diagnosis of influenza virus infection confirmed by all of the following: fever =/> 38 C (axillary temperature) at Screening visit and positive rapid influenza diagnostic test (RIDT) by nasopharyngeal (if difficult, nasal or throat) swabs.
    - Patients with onset of symptoms within 48 hours at the time of informed consent.
    E.4Principal exclusion criteria
    - Patients with severe symptoms of influenza virus infection requiring inpatient treatment.
    - Patients with any of the following high risk factors: chronic respiratory diseases, neurological and neurodevelopmental disorders, heart disease, blood disorders, endocrine disorders, kidney disorders, liver disorders, metabolic disorders, compromised immune system.
    - Patients with any disturbance of consciousness, abnormal behavior or convulsions at Screening, or with a current condition of encephalitis or encephalopathy.
    - Patients with history of encephalitis, encephalopathy, epilepsy, or influenza virus infection associated abnormal behavior within the past 2 years.
    - Patients with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at Screening.
    - Patients who have received baloxavir marboxil (Xofluza®), peramivir (Rapiacta®), laninamivir (Inavir®), oseltamivir (Tamiflu®), zanamivir (Relenza®) or amantadine (Symmetrel®) within 30 days prior to Screening (including prophylaxis).
    - Patient with known allergy and/or history of significant intolerance against baloxavir marboxil and/or acetaminophen.
    - Patients with severe underlying diseases.
    - Patients who have been exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to Screening.
    E.5 End points
    E.5.1Primary end point(s)
    Time to alleviation of influenza illness
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 through Day 14
    E.5.2Secondary end point(s)
    1) Influenza virus titer
    2) Amount of virus RNA (reverse transcription polymerase chain reaction [RT-PCR])
    3) Change from baseline in influenza virus titer
    4) Change from baseline in the amount of virus RNA (RT-PCR)
    5) Percentage of participants positive for influenza virus titer
    6) Percentage of participants positive by RT-PCR
    7) Area under the curve in virus titer
    8) Area under the curve in the amount of virus RNA (RT-PCR)
    9) Time to cessation of viral shedding by virus titer
    10) Time to cessation of viral shedding by RT-PCR
    11) Time to resolution of fever
    12) Percentage of participants reporting normal temperature
    13) Body temperature
    14) Time to alleviation of individual symptoms
    15) Time to resumption of normal activity
    16) Percentage of participants of influenza-related complications
    17) Percentage of participants of influenza-related complications particularly seen in pediatric patients
    18) Plasma concentrations of S-033447
    19) Percentage of participants with adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-6) Predose on Day 1, Days 2, 3, 4 (one visit on either Day 3 or Day 4 is mandatory), 6, 9; if flu symptoms persist: on Days 15, 22
    7-10) Day 1 up to Day 22
    11) Day 1 up to Day 14
    12-13) Predose on Day 1 up to Day 14
    14-15) Day 1 up to Day 14
    16-17) Predose on Day 1 up to Day 22
    18) 0.5 to 2 hours postdose on Day 1, Day 2, at one time point during the period from Day 6 to 22, and at Day 3 and/or Day 4 as needed
    19) Day 1 up to Day 22
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 30
    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: 30
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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