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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2016-004009-15
    Sponsor's Protocol Code Number:VIS410-203
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-28
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2016-004009-15
    A.3Full title of the trial
    Phase 2b, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Intravenous VIS410 in Addition to Oseltamivir (Tamiflu®) Compared With Oseltamivir Alone in Hospitalized Adults With Influenza A Infection Requiring Oxygen Support
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to compare the benefit and safety of a single infusion of VIS410, the study medicine added to standard Tamiflu® treatment to that of treatment with Tamiflu® alone in hospitalized adults with flu infection requiring oxygen support
    A.4.1Sponsor's protocol code numberVIS410-203
    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 SponsorVisterra, 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 supportVisterra, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVisterra, Inc.
    B.5.2Functional name of contact pointDavid Oldach MD,
    B.5.3 Address:
    B.5.3.1Street Address275 Second Avenue, 4th Floor
    B.5.3.2Town/ cityWaltham, MA
    B.5.3.3Post code02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number1443629 0913
    B.5.5Fax number1617498 1073
    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.3.2Product code VIS410
    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 INNVIS410
    D.3.9.2Current sponsor codeVIS410
    D.3.9.3Other descriptive nameVIS410
    D.3.9.4EV Substance CodeSUB175945
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 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
    Influenza A infection in hospitalized patients who need supplemental oxygen
    E.1.1.1Medical condition in easily understood language
    Flu infection in hospitalized patients who need mechanical breathing assistance
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10022002
    E.1.2Term Influenza A virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary efficacy objective is the evaluation of the effect of 2 dose levels of VIS410 + oseltamivir on clinical outcome as assessed by comparison of clinical status ordinal scale Day 7 scores between
    treatment groups, and between all VIS410 recipients versus placebo.

    The primary safety objective is to evaluate safety and tolerability of 2 dose levels of a single intravenous (IV) dose of VIS410 when administered in combination with oseltamivir in hospitalized subjects with influenza A infection
    E.2.2Secondary objectives of the trial
    • Among patients requiring supplemental oxygen therapy at the time of enrollment with baseline room air oxygen saturation of ≤92%, time to
    cessation of oxygen (O2) support resulting in stable oxygen saturation (SpO2) by pulse oximetry. Stable SpO2 is defined as two consecutive
    SpO2 values of > 92% on room air that are at least 8 hours apart.
    • For any patient requiring supplemental oxygen therapy at the time of
    enrollment (regardless of oxygen saturation), time to cessation of oxygen support.
    • Evaluate the effect of VIS410 + oseltamivir vs oseltamivir alone on the
    parameters described on the protocol.
    •Pharmacokinetics of VIS410 in serum
    • Immunogenicity of VIS410
    • Emergence of resistance to VIS410 and oseltamivir
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting all of the following criteria are eligible to participate in this study:
    1. Male and female subjects aged ≥ 18 years. For a country where the legal age of consent is >18 years old, the country requirements should be followed.
    2. Test positive for influenza A by rapid antigen test or with another commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions, or an acceptable local test including, PCR, FIA, or ELISA
    3. Onset of influenza symptoms no more than 5 days before VIS410/placebo infusion; symptoms may include cough, dyspnea, sore throat, fever, myalgias, headache, nasal symptoms (rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea, and vomiting.
    4. Requirement for oxygen support including and positive pressure ventilation (PPV).
    5. Women of childbearing potential must have a negative pregnancy test within 2 days prior to VIS410/placebo infusion.
    6. Women should fulfill one of the following criteria:
    a. Post-menopausal; either amenorrhea ≥ 12 months or follicle stimulating hormone > 40 mIU/mL as documented in their medical history
    b. Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation
    c. Women of childbearing potential participating in heterosexual relations must be willing to use adequate contraception from screening until 60 days post VIS410/placebo infusion (see Section 6.2).
    7. Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method (see Section 6.2) when having heterosexual intercourse, from screening until 60 days post VIS410/placebo infusion.
    8. Subject is able and willing to comply with study procedures, as per protocol.
    9. Subject, or a legally acceptable representative (LAR), is able to understand the purpose and risks of the study and willing to give voluntary written informed consent.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria are excluded from participation in this study:
    1. Known or suspected intolerance or hypersensitivity to VIS410, oseltamivir, pretreatment medications (diphenhydramine, or to both ibuprofen and acetylsalicylic acid [ASA]), or closely related compounds (eg, other monoclonal antibodies).
    2. Subjects who have received VIS410 in the past.
    3. Subjects who have a history of receiving monoclonal antibody products within 3 months prior to VIS410/placebo dosing or planned administration of another monoclonal antibody during the study period.
    4. Subjects who have taken more than 6 doses of an approved antiviral therapy for influenza within the prior 96 hours (eg, oral oseltamivir, inhaled zanamivir, IV peramivir, or oral ribavirin) between onset of symptoms and VIS410/placebo dosing.
    5. Subjects with known co-infection with influenza B or other viral respiratory infections (eg, respiratory syncytial virus {RSV}, parainfluenza viruses, respiratory adenoviruses).
    6. Subjects with lung transplant or history of severe chronic lung disease, including cystic fibrosis or any condition requiring home oxygen therapy.
    7. Subjects on extracorporeal membrane oxygenation at time of randomization.
    8. Subjects with end-stage renal disease (ESRD) who are not undergoing hemodialysis.
    9. Subjects with active graft-vs-host disease, hematopoietic stem cell transplant within the previous 90 days, or human immunodeficiency virus infection with a CD4 cell count of less than 200 per cubic millimeter.
    10. High probability of mortality within 48 hours of randomization as determined by the Investigator.
    11. Women who are pregnant, breast-feeding, or considering to become pregnant.
    12. Subjects in whom nasopharyngeal swabbing is not possible
    13. Subjects weighing less than 45 kg
    14. Enrollment in any other investigational drug or device study, any disease or vaccine study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer.
    15. Presence of any preexisting illness that, in the opinion of the Investigator, would place the subject at an unreasonably increased risk through participation in this study.
    16. Subjects unable to comply with study protocol procedures and study visit schedules for whatever reason.
    17. Known or suspected alcohol or drug abuse, that is, abuse of a level that would compromise the safety or cooperation of the subject in the opinion of the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome analysis compares Day 7 clinical status
    ordinal scale scores between treatment groups, and between all VIS410
    recipients versus placebo. Clinical status is measured daily for 14 days
    using the below seven-level ordinal scale, with the classifications
    presented from the worst clinical outcome to the best clinical outcome in
    descending order; for each day, subject status will be classified by the
    worst clinical outcome for which they qualify.
    _Death
    _ICU stay with mechanical ventilation
    _ICU stay without mechanical ventilation
    _Non-ICU hospitalization with supplemental oxygen
    _Non-ICU hospitalization without supplemental oxygen
    _Discharge with partial resumption of normal activities
    _Discharge with full resumption of normal activities
    The primary safety endpoint is the proportion of subjects with AEs and
    SAEs following administration of VIS410.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoints can be evaluated by hospital staff at any time while the patient is hospitalized or during patient visit in case of a discharged patient.
    E.5.2Secondary end point(s)
    The difference between VIS410 + oseltamivir and oseltamivir alone
    treatment groups in the following endpoints:
    • Among patients requiring supplemental oxygen therapy at the time of
    enrollment with baseline room air oxygen saturation of ≤ 92%, time to
    cessation of oxygen (O2) support resulting in stable oxygen saturation
    (SpO2) by pulse oximetry. Stable SpO2 is defined as two consecutive
    SpO2 values of > 92% on room air that are at least 8 hours apart.
    • For any patient requiring supplemental oxygen therapy at the time of
    enrollment (regardless of oxygen saturation), time to cessation of
    oxygen support
    • Peak viral load,viral AUC, duration of viral shedding, and time to
    resolution of viral load from nasopharyngeal swabs by TCID50 and qRTPCR
    • Time to clinical response defined as resolution of at least 4 of 5 vital signs
    _Afebrile with core temperature ≤ 37.8°C, without use of antipyretics
    (oral < 37.2°C)
    _Oxygen saturation ≥ 95% on room air without support or a return to
    pre-infection status, if pre-infection status was < 95%
    _Pulse rate ≤ 100/min
    _Systolic blood pressure ≥ 90 mm/Hg, without vasopressor use
    _Respiratory rate ≤ 24 beats per minute
    _Respiratory rate ≤ 24 beats per minute
    • Clinical status ordinal scale mean area under the curve for Days 1-7
    and Days 1-14 using linear numeric scores for the ordinal categories.
    • Comparison of clinical status ordinal scale scores for selected
    individual days (i.e., Days 3, 4, 5, and 6)
    • Comparison of clinical status ordinal scale scores using modified
    ordinal scale criteria (i.e,. pooling of selected severity criteria scores)
    • Comparison of discrete ordinal scale parameters, including days of
    ventilator support, days in intensive care, and duration of hospitalization
    • Number of days to resumption of usual activities
    • All-cause and attributable mortality rates at Day 14, 28 and 56
    • Total number of days in hospital and/or intensive care unit (ICU) from
    admission to discharge and rate of rehospitalization due to influenza A
    relapse/complication
    • The incidence, severity, and duration of signs and symptoms of
    influenza-like illness as assessed by the FluPRO Questionnaire (see
    Appendix 14.1)
    • Analysis of time to alleviation of signs and symptoms of influenza in
    the subset of subjects able to complete the Influenza Patient Reported
    Outcomes (FluPRO) Questionnaire at baseline and post-dose by Kaplan
    Meier analysis
    • The percentage of subjects with new bacterial
    pneumonia/superinfection
    • The percentage of subjects with influenza-related complications
    • VIS410 population pharmacokinetic (PK) parameters in serum
    • Titer of anti-VIS410 antibody positive samples
    • Genotypic and/or phenotypic assessment to determine the emergence
    of VIS410 and oseltamivir-resistant viruses
    E.5.2.1Timepoint(s) of evaluation of this end point
    The endpoints can be evaluated by hospital staff at any time while the patient is hospitalized or during patient visit in case of a discharged patient.
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Australia
    Belarus
    Belgium
    Bulgaria
    Canada
    Estonia
    France
    Georgia
    Latvia
    Malaysia
    New Zealand
    Russian Federation
    Serbia
    Singapore
    South Africa
    Spain
    Thailand
    Turkey
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    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)
    None
    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 Decision2017-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-28
    P. End of Trial
    P.End of Trial StatusCompleted
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