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    Summary
    EudraCT Number:2018-004056-37
    Sponsor's Protocol Code Number:MV40618
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-07-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-004056-37
    A.3Full title of the trial
    A PHASE IIIB, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CLINICAL EFFICACY STUDY OF BALOXAVIR
    MARBOXIL FOR THE REDUCTION OF DIRECT TRANSMISSION OF INFLUENZA FROM OTHERWISE HEALTHY PATIENTS TO
    HOUSEHOLD CONTACTS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza from Otherwise Healthy Patients to Household Contacts
    A.3.2Name or abbreviated title of the trial where available
    Centerstone
    A.4.1Sponsor's protocol code numberMV40618
    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 SponsorF. 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.5.6E-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 nameBaloxavir marboxil
    D.3.2Product code RO7191686/F04
    D.3.4Pharmaceutical form Tablet
    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.3.9.4EV Substance CodeSUB190816
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboTablet
    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
    E.1.1.1Medical condition in easily understood language
    Influenza commonly known as flu, is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs
    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 evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo to prevent secondary within-household transmission of influenza A or B
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo to prevent transmission of influenza A or B beyond secondary within-household transmission
    • To evaluate the safety and tolerability of a single, oral dose of baloxavir marboxil compared with placebo
    • To evaluate index patients treated with baloxavir marboxil compared with those receiving placebo with respect to health status utility measures
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Index Patient(s) (IP or IPs) will be screened first at the site whereas Household Contact(s) (HHC or HHCs) will be screened at the home or site after randomization. HHCs must be enrolled within 24 hours of IP randomization. No HHC will be enrolled before all HHCs have been screened.
    IP inclusion criteria
    - Age >=12 and <=64 years
    - Able to comply with the study protocol per investigator judgment
    - Diagnosed with acute influenza infection by investigator
    - Polymerase chain reaction [PCR] (+) or Rapid Influenza Diagnostic Test [RIDT] (+) for influenza A/B based local laboratory results
    - Presence of (a) fever or (b) any influenza symptoms
    - The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is ≤48 hours
    - IP lives in a household where:
    o No HHC is known to have been diagnosed with influenza by a healthcare professional (HCP)
    o All HHCs are expected to meet the HHC inclusion criteria required for “All HHC living in the home at any time during the study” and none of the HHC exclusion criteria
    o ≥2 HHCs are expected to participate in the full study who have not received the influenza vaccine within 6 months prior to screening
    - Women of childbearing potential agree to remain abstinent or use contraceptive measures
    Household Contact (HHC) inclusion criteria
    1. All HHC living in the home at any time during the study must meet the following criteria
    - PCR (-) or RIDT (-) based on local laboratory result at Day 0 Visit
    - Willing to undergo screening visit as a scheduled/unscheduled visit after they return to the home if not at home at Day 0 Visit

    2. HHC intended for full study must meet the following additional criteria for study entry
    - No influenza symptoms within 7 days prior to screening; mild symptoms allowed if due to pre-existing condition (e.g. allergies)
    - Tympanic temperature <38°C at screening
    - Will reside in the IP’s house for at least 7 of the next 9 days and will be present for scheduled study visits
    - Willing/able to measure/record temperature, or have another household member perform the task on his/her behalf. Furthermore, a responsible adult will assume responsibility to oversee or perform this task on behalf of minors
    - Has not been diagnosed with influenza or taken antivirals for influenza ≤6 months prior to screening
    - Does not have moderate or worse active infections OR taking systemic or an internally administered anti -biotic/ -viral/ -fungal
    - HHC lives in a household where:
    o No HHC has been diagnosed with influenza by an HCP
    o All HHCs meet the HHC inclusion criteria required for “All HHC living in the home at any time during the study” and none of the HHC exclusion criteria
    o ≥2 HHCs have not received the influenza vaccine ≤6 months prior to screening agree to participate in the full study
    E.4Principal exclusion criteria
    IP exclusion criteria
    - IPs with severe influenza virus infection requiring inpatient treatment
    - IPs judged by the investigator to be at high risk for complications of influenza, after consideration of the following or other potential risk factors:
    o Women who are pregnant or within 2 weeks post-partum;
    o Chronic respiratory diseases including chronic obstructive pulmonary disorder current asthma and cystic fibrosis;
    o Neurological and neurodevelopmental disorders, heart disease, blood disorders, endocrine disorders, kidney disorders, liver disorders, metabolic disorders, and morbid obesity;
    o Compromised immune system due to disease or medications;
    o People younger than 19 years of age on long-term aspirin- or salicylate-containing medications;
    o American Indians or Alaska Natives;
    o People who live in nursing homes and other long-term care facilities
    - IPs unable to swallow tablets
    - Women who are breastfeeding or have positive pregnancy test at pre-dose screening (unless exempted due to postmenopausal status or surgically sterile).
    - IPs weighing <40 kg
    - IPs with concurrent (non-influenza) infections requiring systemic anti -microbial / -viral therapy at the pre-dose examinations
    - IPs who have received an investigational monoclonal antibody for a viral disease in the last year
    - IPs who have received an investigational therapy within 30 days or 5 drug-elimination half-lives, whichever is longer, prior to screening
    - IPs living with another person who, based on available information meets the HHC exclusion criteria
    - Known hypersensitivity to baloxavir marboxil or the drug product excipients
    - Any other contraindication for treatment with baloxavir marboxil as deemed by the treating physician or Principal Investigator
    HHC exclusion criteria
    - Pregnant or within 2 weeks post-partum at screening
    - Immunocompromised (including HHC receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus [HIV] infection)
    - <2 years old
    - HHC who have received an investigational therapy within the 30 days or 5 drug-elimination half-lives, whichever is longer, prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of HHC who become PCR+ for influenza by Day 5 post IP randomization. HHCs may be symptomatic or asymptomatic and their virus subtype must match that of the IP in their household. The primary efficacy analysis population will consist of all enrolled unvaccinated HHCs of the randomized IPs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline to Day 5 (5 days)
    E.5.2Secondary end point(s)
    1. Percentage of HHCs who become PCR+ for influenza by Day 9 post IP randomization
    2. Percentage of HHCs who become PCR+ for influenza by Day 5 post IP randomization AND report influenza symptoms at any time during the study.
    3. Percentage of Households with at least one HHC who meets the Primary Endpoint
    4. Percentage of IP with Adverse Events (AEs)
    5. IP only: Change from baseline in health-related quality of life according to EuroQol 5 dimensions 5 (EQ-5D-5L; Appendix 3) questionnaire at Day 3 and Day 9 Visits
    6. IP only: Change from Baseline in work productivity according to Work Productivity and Activity Impairment (WPAI) plus Classroom Impairment Questions Score at Day 9
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline to Day 9 (9 days)
    2. Baseline up to Day 5 (5 days)
    3. Baseline to Day 9 (9 days)
    4. Baseline to Day 9 (9 days)
    5. Day 3 and Day 9 (versus baseline)
    6. Day 9 (versus baseline)
    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 No
    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 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 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 concerned5
    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
    Argentina
    Brazil
    China
    Costa Rica
    Greece
    Hong Kong
    India
    Israel
    Japan
    Mexico
    Singapore
    South Africa
    Spain
    Switzerland
    Turkey
    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 this study is defined as the date when the last patient, last visit (LPLV) occurs.
    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 months1
    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 months1
    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: 113
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 113
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1017
    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 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 state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 1130
    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 IMP (baloxavir marboxil) 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 Decision2019-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-11
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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