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    Summary
    EudraCT Number:2009-016035-35
    Sponsor's Protocol Code Number:NAI113678
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-09-02
    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 number2009-016035-35
    A.3Full title of the trial
    An Open-Label, Multi-Center, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Zanamivir in the Treatment of Hospitalized Adult, Adolescent and Pediatric Subjects with Confirmed Influenza Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of intravenous zanamivir in adults, teenagers and children with influenza
    A.4.1Sponsor's protocol code numberNAI113678
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/097/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGSK UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Roadn
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4420 8990 4466
    B.5.5Fax number4420 8990 1234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameIV zanamivir
    D.3.4Pharmaceutical form 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 INNzanamivir
    D.3.9.1CAS number 139110-80-8
    D.3.9.2Current sponsor codeGR121167
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Hospitalized adult, adolescent and pediatric subjects with influenza infection.
    E.1.1.1Medical condition in easily understood language
    Flu
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 safety and tolerability of IV zanamivir in the treatment of hospitalized adult, adolescent and pediatric subjects with influenza infection.
    E.2.2Secondary objectives of the trial
    • To evaluate the serum pharmacokinetics of IV zanamivir in a subset of hospitalized adult, adolescent and pediatric subjects with influenza infection.
    • To assess viral load (from nasopharyngeal swabs) in hospitalized subjects with influenza infection following treatment with IV zanamivir.
    • To evaluate the clinical course of illness in hospitalized subjects with influenza infection following treatment with IV zanamivir.
    • To evaluate viral susceptibility and resistance to zanamivir.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged ≥ 6 months of age; a female is eligible to enter and participate in the study if she is:
    a. of non-childbearing potential (i.e., physiologically incapable of becoming
    pregnant, including any female who is post-menopausal); or,
    b. of child-bearing potential, has a negative pregnancy test at Baseline, and agrees to one of the following methods for avoidance of pregnancy during the study and until the Post-Treatment +23 Days Follow-up Assessment:
    • Abstinence; or,
    • Oral contraceptive, either combined or progestogen alone; or,
    • Injectable progestogen; or,
    • Implants of levonorgestrel; or,
    • Estrogenic vaginal ring; or,
    • Percutaneous contraceptive patches; or
    • Intrauterine device (IUD) or intrauterine system (IUS) showing that the
    expected failure rate is less than 1% per year as stated in the IUD or IUS
    Product Label; or,
    • Has a male partner who is sterilized; or,
    • Double barrier method: condom and an occlusive cap (diaphragm or
    cervical/vault caps) with a vaginal spermicidal agent
    (foam/gel/film/cream/suppository).
    2. Subjects who have confirmed influenza as determined by a positive result in a rapid test for influenza A or influenza B, or a laboratory test for influenza including influenza virus antigen test, virus culture or RT-PCR test. Subjects with negative rapid test result suspected of having influenza can be enrolled following confirmatory testing by RT-PCR, antigen test or culture.
    3. Hospitalized subjects with symptomatic influenza.
    4. Subjects who are able to receive their first dose of study medication within seven days of experiencing influenza-like symptoms.
    5. Inclusion Criteria #5 was removed in Protocol Amendment 04.
    6. Subjects willing and able to adhere to the procedures stated in the protocol.
    7. Subjects/legally acceptable representative (LAR) of minors and unconscious adults willing and able to give written informed consent to participate in the study (or included as permitted by local regulatory authorities, IRB/IECs or local laws).
    8. French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    9. UK subjects and subjects in Spain: Subjects should be in a high dependency or intensive care setting at the time of enrolment and either have severe and progressive illness on approved influenza antiviral agents, or are considered unsuitable for treatment with approved influenza antivirals.
    10. Subjects who have severe or progressive influenza illness on approved (fully licensed) influenza antiviral agents, or who are considered unsuitable or inappropriate for treatment with approved influenza antivirals, or who in the opinion of the investigator may benefit from IV zanamivir therapy.
    Subjects who meet the entry criteria are considered eligible for the study. This includes, but is not limited to subjects who are intubated/ventilated or receiving extracorporealmembrane oxygenation (ECMO), immunocompromised, HIV positive or have renal impairment and subjects who may have received prior licensed anti-influenza medication.
    E.4Principal exclusion criteria
    1.Subjects who, in the opinion of the investigator, are not likely to survive the next 48 hours beyond Baseline.
    2.Subjects who require concurrent therapy with another influenza antiviral drug.
    3.Subjects who have participated in a study using an investigational influenza antiviral drug within 30 days prior to Baseline.
    4.Subjects who are known or suspected to be hypersensitive to any component of the study medication.
    5.Subjects who meet the following criteria at Baseline:
    ALT > 3xULN and bilirubin > 2xULN or ALT > 5xULN
    6.History of cardiac disease or clinically significant arrhythmia (either on ECG or by history) which, in the opinion of the Investigator, will interfere with the safety of the individual subject.
    7.QT criteria at baseline as defined: QTcB or QTcF > 500 msec; If subject has bundle branch block then criteria is QTcB or QTcF > 530 msec.
    8.Child in care (CiC) as defined below:
    A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
    The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.
    9. French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days. This criterion may also apply in other countries if required by local regulatory authorities or IRB/IECs.
    10. Females who are pregnant (positive urine or serum pregnancy test at Baseline) or are breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    • Adverse events. These will be coded using MedDRA and summarized by system organ class and preferred term for:
    i) the overall incidence of adverse events,
    ii) the incidence of adverse events considered to be related to study treatment
    iii) the incidence of grade 3/4 or severe adverse events
    iv) the incidence of adverse events leading to discontinuation of study drug
    v) the incidence of adverse events leading to discontinuation from the study
    vi) the incidence of serious adverse events
    vii) the incidence of treatment-related serious adverse events
    viii) the incidence of severe or grade 3 and 4 treatment-related adverse events.
    ix) the incidence of fatal serious adverse events

    • Clinical laboratory data: Clinical chemistry and hematology data will be listed, flagging values outside the normal range. Clinical laboratory data will also be summarized based on changes from baseline and toxicity shifts from baseline. Summary of treatment emergent laboratory toxicities by intensity will be tabulated for each lab parameter.
    • Vital Signs: Heart rate, blood pressure, systolic and diastolic blood pressure, oxygen saturation, respiration rate and temperature will be listed and summarized by study visit. In addition, change from baseline of the vital signs will also be summarized.
    •ECG data: A summary of the number and percentage of subjects who had abnormal and/or clinically significant ECG findings will be displayed. If available, ECG interval data and change from baseline will be summarized. QTc interval will be calculated by both Bazett's (QTcB) and Fridericia's (QTcF) formula.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the course of the study
    E.5.2Secondary end point(s)
    • Change in quantitative viral load over time and change from baseline measured from nasopharyngeal swab samples, as determined by quantitative virus culture (and retrospectively by RT-PCR, if available)
    • Time to no detectable viral RNA and to absence of cultivable virus in nasopharyngeal samples.
    • Proportion of subjects who are negative by virus culture (and RT-PCR if available) in nasopharyngeal samples [ Time Frame: Day 3 and all subsequent timepoints during the study ]
    • Viral susceptibility to zanamivir at baseline, and if virus present, at subsequent timepoints during the study, as assessed by NA sequence analysis and NA enzyme inhibition assay [ Time Frame: Baseline and all subsequent timepoints during the study ]
    • Frequency of resistance emergence to zanamivir
    • All cause mortality rate
    • Incidence of complications of influenza and associated antibiotic use
    • Ventilation status: duration of supplemental oxygen and of mechanical ventilation
    • Time to afebrile status
    • Length of ICU and hospital stays
    • Level of activity (bed rest, limited ambulation or unrestricted) over time and time to return to pre-morbid functional status
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the course of the study
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Evaluate viral susceptibility and resistance
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 trial1
    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
    Australia
    Brazil
    Canada
    France
    Russian Federation
    South Africa
    Spain
    Thailand
    United Kingdom
    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
    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 years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days10
    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: 50
    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: 16
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 34
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    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: 35
    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 Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects/legally acceptable representative (LAR) of minors and unconscious adults willing and able to give written informed consent to participate in the study.
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    subjects who are intubated/ventilated, immunocompromised, HIV positive or renal impairment
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    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)
    No post-study medication is provided as part of this protocol.
    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: Russian Federation
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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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