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    Summary
    EudraCT Number:2014-002137-58
    Sponsor's Protocol Code Number:GS-US-218-1227
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-16
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-002137-58
    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 Hospitalized Adults with Respiratory Syncytial Virus (RSV) Infection
    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-218-1227
    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 Information
    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 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 INNnot yet assigned
    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 number200
    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
    Respiratory Syncytial Virus (RSV) Infection
    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 17.0
    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
    The primary objective of this study is to evaluate the effects of
    GS-5806 on RSV viral load in RSV-positive adults hospitalized
    with acute respiratory infectious symptoms.
    E.2.2Secondary objectives of the trial
    The effect of GS-5806 on change in the FLU-PRO score
    from Baseline
    The effect of GS-5806 on the length of hospital stay
    The effect of GS-5806 on the rate of unplanned healthcare
    encounters (clinic visits, emergency room visits, urgent care
    visits, and rehospitalizations) related to a respiratory illness
    after discharge
    The pharmacokinetics (PK), safety, and tolerability of GS-
    5806
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    An informed consent document signed and dated by the subject or a legal guardian of the subject and Investigator or his/her designee
    Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 5 of the protocol.
    Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm donation while enrolled in the study and for at least 90 days after administration of the last dose of study medication.
    All subjects must refrain from blood donation while enrolled in the study and for 30 days after the last dose of IMP.
    ≥ 18 years of age at Screening
    Willing to adhere to protocol specific requirements for contraception
    Admission to the hospital primarily for a respiratory related illness
    New onset or acute worsening of at least 1 respiratory infectious symptom from each category for ≤ 5 days prior to screening:
    Upper respiratory tract symptoms: Nasal congestion, runny nose, sore throat, or earache
    Lower respiratory tract symptoms: Cough, sputum production, wheezing, dyspnea, or chest tightness
    Willingness to perform necessary study procedures and have available a working
    telephone or email
    Documented to be RSV-positive at the current admission within 72 hours of Screening, or as evaluated at Screening
    E.4Principal exclusion criteria
    Related to concomitant or previous medication use:
    - Use of any investigational medicinal product in the 28 days prior to screening, OR use of any investigational monoclonal antibody within 4 months or 5 half-lives of screening, whichever is longer, OR use of any investigational RSV vaccine ever
    - Chronic use (> 28 days of use) of systemic immunosuppressive agents (i.e. alkylating agents, calcineurin inhibitors, immunophilin-binding but not a calcineurin inhibitor, antimetabolites, polyclonal antibodies, monoclonal antibodies) during the 28 days prior to Screening, or anticipated use during the 28 days following Screening
    -Chronic use (> 28 days of use) of oral prednisone equivalent to > 20 mg/day. Chronic prednisone doses equivalent to ≤ 20 mg/day is acceptable. Short courses (≤ 28 days prior to Screening) of oral prednisone equivalent to > 20 mg/day is acceptable if used > 14 days prior to Screening
    - Subjects taking a strong CYP inducer including but not limited to rifampin, St John’s wort, carbamazepine, and phenytoin
    Related to medical history:
    -Pregnant, breastfeeding, or lactating females
    -Subjects requiring > 50% supplemental oxygen (while the subject is awake) at Screening
    - Subjects with a CFS > 7 at Baseline
    - Any clinically significant history of a bleeding disorder (as determined by the
    investigator) at any time in the past or epistaxis (as determined by the investigator) within 30 days prior to screening
    Known significant abnormality altering the anatomy of the nose or nasopharynx that in, the opinion of the investigator, will preclude obtaining adequate nasal swab sampling in either nasal passage
    -Waiting for or recently (within the past 12 months) received a bone marrow, stem cell, or solid organ transplant, or who have received radiation or chemotherapy within 12 months prior to screening
    - Known history of HIV/AIDS, hepatitis B or C
    -History of severe dementia or Alzheimer’s disease
    - History of drug and/or alcohol abuse that, in the opinion of the investigator, may prevent adherence to study activities
    Related to medical condition:
    - Influenza-positive as determined by local diagnostic test
    - New onset of arrhythmia during current admission
    -Use of mechanical ventilation during the current admission, not including noninvasive ventilation
    - Positive bacteremia or fungemia at the current admission
    - Inadequate treatment of confirmed bacterial, fungal, or non-RSV pneumonia, as
    determined by the investigator
    - New cerebrovascular accident or stroke documented at the current admission
    - Admission for trauma or emergent or planned surgeries
    - Excessive nausea/vomiting at admission, as determined by the investigator, that precludes administration of an orally administered IMP
    Related to allergies:
    - Known allergy to components of the IMP (microcrystalline cellulose, mannitol,
    croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide,
    polyethylene glycol and talc).
    - Documented history of acute (anaphylaxis) or delayed (Stevens-Johnson syndrome or epidermal necrolysis) allergy to sulfa drugs
    Related to laboratory results at Screening:
    -Serum creatinine clearance <50 mg/dL
    -AST/ALT > 2x ULN
    - Total bilirubin > 2x ULN
    - Hemoglobin (Hb) < 10 mg/dL
    - WBC <4000 cells/μL
    -Neutrophil count < 1500 cells/μL
    - Platelet count of < 100,000/μL
    E.5 End points
    E.5.1Primary end point(s)
    Time-weighted average change in log10 viral load from Baseline (Day 1) to Day 5.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 and 5
    E.5.2Secondary end point(s)
    -Time-weighted average change in the FLU-PRO score from Baseline (Day 1) to Day 5
    - Duration of hospital stay following IMP administration
    - Rate of unplanned medical encounters (clinic visits, emergency room visits, urgent care visits, and rehospitalizations) related to a respiratory illness after initial hospital discharge through Day 28
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 5 and 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Canada
    Korea, Republic of
    New Zealand
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    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 Decision2014-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-12
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