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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2014-002474-36
    Sponsor's Protocol Code Number:GS-US-218-0108
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-17
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-002474-36
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients with Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 clinical trial investigating the anti-virus effects, kinetics and safety of GS-5806 in adults with RSV (Respiratory Syncytial Virus) infection.
    A.4.1Sponsor's protocol code numberGS-US-218-0108
    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 SponsorGilead Sciences, 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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park, Abington
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223897496
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.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 nameGS-5806
    D.3.2Product code GS-5806
    D.3.4Pharmaceutical form Film-coated 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 INNpresatovir
    D.3.9.1CAS number 1353625-73-6
    D.3.9.2Current sponsor codeGS-5806
    D.3.9.3Other descriptive nameGS-5806
    D.3.9.4EV Substance CodeSUB75034
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboFilm-coated tablet
    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
    Respiratory Syncytial Virus (RSV) Infection of the upper respiratory tract.
    E.1.1.1Medical condition in easily understood language
    Respiratory Syncytial Virus (RSV) Infection is a respiratory virus that infects the lungs and breathing passages.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10039247
    E.1.2Term RSV 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
    co-primary objectives of this study are:
    To evaluate the effect of presatovir on RSV viral load and development of LRTC in RSV-positive autologous or allogeneic HCT recipients with acute URTI symptoms
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of presatovir on development of LRTC, progression to respiratory failure, and all-cause mortality
    - To evaluate the PK, safety, and tolerability of presatovir
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male and female subjects 18 to 75 years of age. In Japan
    subjects must be 20 to 75 years of age. In Singapore subjects must be
    21 to 75 years of age
    2. Received an autologous or allogeneic HCT using any conditioning
    regimen
    3. Documented to be RSV-positive as determined by local testing (eg,
    PCR, DFA, RVP assay, or culture) using an upper respiratory tract sample
    collected ≤ 6 days prior to Day 1 or as determined at Screening as per Section 6.1.1
    4. New onset of at least 1 of the following respiratory symptoms for ≤ 7
    days prior to Day 1: nasal congestion, runny nose, cough, or sore throat,
    or worsening of one of these chronic (associated with a previously
    existing diagnosis, eg, chronic rhinorrhea, seasonal allergies, chronic
    lung disease) respiratory symptoms ≤ 7 days prior to Day 1
    5. No evidence of new abnormalities consistent with LRTI on a chest Xray
    relative to the most recent chest X-ray, as determined by the local
    radiologist. If a chest X-ray is not available or was not obtained during
    standard care < 48 hours prior to Screening, a chest X-ray must be
    obtained for Screening
    6. O2 saturation ≥ 92% on room air
    7. An informed consent document signed and dated by the subject or a
    legal guardian of the subject and the investigator or his/her designee. In
    Sweden ICFs signed by a legal guardian must also be signed by a close
    relative of the subject
    8. A negative urine or serum pregnancy test is required for female
    subjects (unless surgically sterile or greater than two years postXML
    File Identifier: uTJrJoSmpFLIfUvCfdETFRFxWC4=
    Page 11/26
    menopausal)
    9. Male and female subjects of childbearing potential must agree to
    contraceptive requirements as described in Appendix 5
    10. Willingness to complete necessary study procedures and have
    available a working telephone or email
    E.4Principal exclusion criteria
    Related to concomitant or previous medication use:
    1. Use of non-marketed (according to region) investigational agents
    within 30 days, OR use of any investigational monoclonal anti-RSV
    antibodies within 4 months or 5 half-lives of Screening, whichever is
    longer, OR use of any investigational RSV vaccines after HCT.
    2. Use of a moderate or strong cytochrome P450 enzyme (CYP) inducer
    including but not limited to rifampin, St. John's Wort, carbamazepine,
    phenytoin, efavirenz, bosentan, etravirine, modafinil, and nafcillin,
    within 2 weeks prior to the first dose of IMP
    Related to medical history:
    3. Admitted to the hospital primarily for a lower respiratory tract disease
    of any cause as determined by the investigator
    4. Pregnant, breastfeeding, or lactating females
    5. Unable to tolerate nasal sampling required for this study, as
    determined by the investigator
    6. Known history of HIV/AIDS with a CD4 count <200 cells/μL within the
    last month
    7. History of drug and/or alcohol abuse that, in the opinion of the
    investigator, may prevent adherence to study activities
    Related to medical condition at Screening:
    8. Documented to be positive for other respiratory viruses (limited to
    influenza, parainfluenza, human rhinovirus, adenovirus, human
    metapneumovirus, or coronavirus) within 7 days prior to the Screening
    visit, as determined by local testing (additional testing is not required)
    9. Clinically significant bacteremia or fungemia within 7 days prior to
    Screening that has not been adequately treated, as determined by the
    investigator
    10. Clinically significant bacterial, fungal, or viral pneumonia within 2
    weeks prior to Screening that has not been adequately treated, as
    determined by the investigator
    11. Excessive nausea/vomiting at Screening, as determined by the
    investigator, or an inability to swallow pills that precludes oral
    administration of the IMP (for subjects without an NG tube in place)
    12. Any condition which, in the opinion of the investigator, would
    prevent full participation in this trial or would interfere with the
    evaluation of the trial endpoints
    Related to allergies:
    13. Known hypersensitivity or allergy to the IMP, its metabolites, or
    formulation excipients (microcrystalline cellulose, mannitol,
    croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium
    dioxide, polyethylene glycol and talc)
    14. History of hypersensitivity, anaphylactic reaction, Stevens-Johnson
    Syndrome, or toxic epidermal necrolysis response to sulfa drugs
    Related to laboratory results:
    15. Creatinine clearance < 30 mL/min (calculated using the Cockcroft-
    Gault method)
    16. Clinically significant ALT/AST, as determined by the investigator
    17. Clinically significant TB, as determined by the investigator
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary endpoints are:

    Time-weighted average change in nasal RSV viral load (log10 copies/mL) from Baseline (Day 1) to Day 9 as measured by RT-qPCR

    Proportion of subjects who develop a LRTC through Day 28, defined as
    one of the below, as determined by the adjudication committee:
    -Primary RSV LRTI
    -Secondary bacterial LRTI
    -Lower respiratory tract infection due to unusual
    pathogens
    -Lower respiratory tract complication of unknown
    etiology
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change in nasal RSV viral load: Day 1 to day 9 (daily measure)

    Development of LRTC: day 28
    E.5.2Secondary end point(s)
    Proportion of subjects developing respiratory failure (of any cause)
    requiring mechanical ventilation (invasive or noninvasive) or all-cause mortality through Day 28
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 28.
    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) 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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Austria
    Brazil
    Canada
    France
    Germany
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Singapore
    Spain
    Sweden
    Switzerland
    Taiwan
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 71
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Yorkshire and Humber
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-14
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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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