Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36808   clinical trials with a EudraCT protocol, of which   6077   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-001653-40
    Sponsor's Protocol Code Number:64041575RSV2003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-09-05
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-001653-40
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2b study for adults hospitalized with Respiratory Syncytial Virus.
    A.3.2Name or abbreviated title of the trial where available
    A Phase 2b study for adults with Respiratory Syncytial Virus.
    A.4.1Sponsor's protocol code number64041575RSV2003
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen-Cilag International NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointGuy De La Rosa, MD
    B.5.3 Address:
    B.5.3.1Street Address1125 Trenton-Harbourton Road, K20906
    B.5.3.2Town/ cityTitusville, NJ
    B.5.3.3Post code08560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 6097307553
    B.5.6E-mailgdelaros@its.jnj.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 nameALS-008176
    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 INNLumicytabine
    D.3.9.1CAS number 1445385-02-3
    D.3.9.2Current sponsor codeALS-008176
    D.3.9.3Other descriptive nameJNJ-64041575-AAA
    D.3.9.4EV Substance CodeSUB120906
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 2
    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 nameALS-008176
    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 INNLumicytabine
    D.3.9.1CAS number 1445385-02-3
    D.3.9.2Current sponsor codeALS-008176
    D.3.9.3Other descriptive nameJNJ-64041575-AAA
    D.3.9.4EV Substance CodeSUB120906
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Infection
    E.1.1.1Medical condition in easily understood language
    Viral Infection
    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 PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    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
    For Part 1:
    The primary objective is to characterize the pharmacokinetics (PK) and
    to confirm the population PK (popPK) model derived from healthy
    volunteers in hospitalized adults who are infected with RSV.
    For Part 2:
    The primary objective is to determine in hospitalized adults who are
    infected with RSV the dose-response relationship of multiple regimens of
    ALS-008176 on antiviral activity based on nasal RSV shedding using
    quantitative real-time reverse transcriptase-polymerase chain reaction
    (qRT-PCR) assay.
    E.2.2Secondary objectives of the trial
    • The impact of ALS-008176 on the clinical course of RSV infection
    including:
    − Duration of hospital stay.
    − Duration of supplemental oxygen.
    − Evolution of Activities of Daily Living (ADL) as assessed by Katz ADL
    score.
    − Time to clinical stability.
    − Improvement on the ordinal scale.
    − Rate of mortality and complications.
    • The antiviral activity based on nasal RSV shedding using qRT-PCR
    assay (secondary for Part 1 only) and the time to cessation of nasal RSV
    shedding.
    • The impact of ALS-008176 on the emergence of resistant strains of
    RSV.
    • The safety and tolerability of ALS-008176.
    • The pharmacokinetics (PK) of ALS-008112 and ALS-008144 (and other
    metabolites, if applicable) in plasma.
    • The relationship between the PK and pharmacodynamics (PD; antiviral
    activity, clinical symptoms, and selected safety parameters) after single
    (loading dose [LD]) and repeated oral dosing (maintenance dose [MD])
    of ALS-008176.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential subject must satisfy all of the following criteria to be enrolled in the study:
    1. Men or women ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), defined at the time of randomization.
    2. Hospitalized (or in emergency room prior to hospitalization) at the
    time of randomization and unlikely to be discharged for the first 24
    hours after randomization.
    3. Criterion modified per Amendment 2:
    3.1 Diagnosed with RSV infection based on polymerase chain reaction
    (PCR)-based assay with or without co-infection with another respiratory
    pathogen (eg, influenza, human metapneumovirus, or bacteria).
    4. Criterion modified per Amendment 2:
    4.1 Has an acute respiratory illness with signs and symptoms consistent
    with a viral infection (eg, fever, cough, nasal congestion, runny nose,
    sore throat, myalgia, lethargy, shortness of breath, or wheezing) with
    onset ≤5 days from the anticipated time of randomization.
    5. Criterion modified per Amendment 2:
    5.1 With the exception of the RSV disease, medically stable on the basis
    of medical history, physical examination, vital signs, and 12-lead ECG
    performed at screening. If there are abnormalities, they must be
    consistent with the underlying illness in the study population and/or
    RSV infection. This determination must be recorded in the subject's
    source documents and initialed by the investigator.
    6. Medically stable on the basis of clinical laboratory tests performed at
    screening. If the results of the serum chemistry, haematology, or
    urinalysis are outside the normal reference ranges, the subject may be
    included only if the investigator judges the abnormalities or deviations
    from normal do not pose an unacceptable risk to the subject, are not
    clinically significant, or are appropriate and reasonable for the
    population under study. This determination must be recorded in the
    subject's source documents and initialed by the investigator. A single
    repeat laboratory evaluation is allowed for eligibility determination.
    7. Must sign an ICF (or their legally acceptable representative must sign)
    indicating that he or she understands the purpose of, and procedures
    required for, the study and is willing to participate in the study.
    8. Criterion modified per Amendment 2:
    8.1 A woman must have a negative urine β-human chorionic
    gonadotropin at screening.
    9. Criterion modified per Amendment 2:
    9.1 Contraceptive use by women should be consistent with local
    regulations regarding the use of contraceptive methods for subjects
    participating in clinical studies.
    Before randomization, a woman must be either:
    a. Not of childbearing potential defined as:
    • Postmenopausal: a postmenopausal state is defined as >45 years and
    no menses for 12 consecutive months without an alternative medical
    cause, OR
    • Permanently sterile: permanent sterilization methods include
    hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation
    procedures (without reversal operation), and bilateral oophorectomy.
    b. Of childbearing potential and, if heterosexually active,
    • Practicing a highly effective method of contraception (failure rate of
    <1% per year when used consistently and correctly)
    • Agrees to remain on a highly effective method throughout the study
    and for at least 44 days after the last dose of study drug.
    10. Criterion modified per Amendment 2:
    10.1 Contraceptive use by men should be consistent with local
    regulations regarding the use of contraceptive methods for subjects
    participating in clinical studies.
    During the study and until the end of relevant systemic exposure, plus a
    minimum of 1 spermatogenesis cycle (ie. 104 days in total) after
    receiving the last dose of study drug, a man:
    • Who is sexually active with a woman of childbearing potential must
    agree to use a barrier method of contraception (e.g., condom with
    spermicidal foam/gel/film/cream/suppository)
    • Who is sexually active with a pregnant woman must use a condom
    • Must agree not to donate sperm
    11. Criterion modified per Amendment 2:
    11.1 Female partners of men must either be surgically sterilized,
    postmenopausal (amenorrhea for a minimum of 1 year) or, if of
    childbearing potential, must agree to practice a highly effective method
    of contraception (failure rate of <1% per year when used consistently
    and correctly) during the study and for 104 days following the last dose
    of study drug.
    12. Criterion modified per Amendment 2:
    12.1 A woman must agree not to donate eggs (ova, oocytes) during the
    study and for at least 44 days after receiving the last dose of study drug.
    13. Willing and able to adhere to the prohibitions and restrictions
    specified in this protocol.
    14. Subject must have a body weight ≥50.0 kg, at screening.
    E.4Principal exclusion criteria
    4.2. Exclusion Criteria
    Any potential subject who meets any of the following criteria will be
    excluded from participating in the study:
    1. Subjects who are not expected to survive for more than 48 hours.
    2. Subjects who have had major thoracic or abdominal surgery in the 6
    weeks prior to randomization.
    3. Criterion modified per Amendment 2:
    3.1 Subjects who are considered by the investigator to be
    immunocompromised within the past 12 months, whether due to
    underlying medical condition (e.g., malignancy or genetic disorder) or
    medical therapy (e.g., medications other than corticosteroids for the
    treatment of COPD or asthma exacerbations, chemotherapy, radiation,
    stem cell or solid organ transplant).
    4. Subjects with a known history of human immunodeficiency virus
    (HIV) or chronic viral hepatitis.
    5. Subjects with ALT ≥3 times the upper limit of normal (ULN) AND
    bilirubin ≥2×ULN (direct >35%) OR ALT ≥5×ULN at screening.
    6. Criterion modified per Amendment 2:
    6.1 Subjects undergoing peritoneal dialysis, haemodialysis, or
    hemofiltration or with an estimated glomerular filtration rate (GFR,
    determined by Chronic Kidney Disease Epidemiology Collaboration
    [CKDEPI] equation) of <60 mL/min/1.73m2.
    7. Known allergies, hypersensitivity, or intolerance to ALS-008176 or its
    excipients (refer to the IB).
    8. Criterion deleted per Amendment 2
    9. Subjects unwilling to undergo mid-turbinate nasal swab procedures or
    with any physical abnormality which limits the ability to collect regular
    nasal specimens.
    10. Subjects unable to take medications enterally or with a known
    gastrointestinal-related condition that is considered by the sponsor or
    investigator to be likely to interfere with study drug absorption.
    11. Women who are pregnant or breastfeeding.
    12. Criterion modified per Amendment 2:
    12.1 Men who plan to father a child while enrolled in this study or within
    104 days after the last dose of study drug.
    13. Subjects taking any disallowed therapies as noted in Section 8 before
    the planned first dose of study drug.
    14. Criterion modified per Amendment 2:
    14.1 Subjects who received prescription medications intended to prevent
    or treat the RSV infection itself (eg, ribavirin, IV immunoglobulin,
    palivizumab), an investigational drug, an investigational vaccine, or used
    an invasive investigational medical device within 30 days or 5 half-lives
    (whichever is longer) before the planned first dose of study drug or is
    currently enrolled in an investigational study.
    15. Subjects with any condition for which, in the opinion of the
    investigator, participation would not be in the best interest of the
    subject (e.g., compromise the well-being) or that could prevent, limit, or
    confound the protocol-specified assessments.
    16. Subjects who have used systemic corticosteroids for >7 consecutive
    days immediately prior to randomization at doses higher than 20
    mg/day of prednisone or equivalent.
    17. Subject is being treated with extracorporeal membrane oxygenation.
    18. Subjects with 1 or more of the following laboratory abnormalities at
    screening as defined by the Division of Microbiology and Infectious
    Diseases (DMID) Adult Toxicity Table:
    - Hemoglobin <9.5 g/dL
    - Platelet count <75,000/mm³
    - White blood cell count <1,000/mm³
    - Absolute neutrophil count <1,000/mm³
    E.5 End points
    E.5.1Primary end point(s)
    For Part 1:
    The primary endpoint is the PK of ALS-008112 and ALS-008144 (and
    other metabolites, if applicable) in plasma.
    For Part 2:The primary endpoint is RSV RNA viral load (measured by
    qRT-PCR in the mid-turbinate nasal swab specimens) area under the
    concentration-time curve (AUC) from immediately prior to first dose of
    study drug (baseline) until Day 7.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: PK samples should be collected at:
    Dose 1 (LD): 0.5 to 1 hour postdose, 2 to 3 hours postdose, and 4 to 6
    hours postdose
    Dose 2: predose, 0.5 to 1.5 hour postdose, and 3 to 6 hours postdose
    Dose 3: if patient has not been discharged, predose (preferable), or
    random sample
    Day of discharge if still on study drug: random sample
    Dose 10: if patient has not been discharged, predose (preferable) or
    random sample
    Day 7: random sample at visit
    Day 10: random sample at visit
    If >10 doses are administered upon IDMC recommendation: prior to the
    last dose (if feasible)
    Part 2: Immediately prior to first dose of study drug (baseline) until Day
    7
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    • RSV clinical course endpoints:
    − Length of hospital stay from admission to discharge and from study
    treatment initiation to discharge.
    − Length of hospital stay from admission to readiness for discharge and
    from study treatment initiation to readiness for discharge, with
    readiness for discharge defined by the investigator.
    − Need for and duration of intensive care unit (ICU) stay.
    − Need for and duration of supplemental oxygen (regardless of method
    used).
    − Number of hours until peripheral capillary oxygen saturation (SpO2) ≥
    93% on room air among subjects who were not on supplemental oxygen
    prior to the onset of respiratory symptoms.
    − Respiratory rate, SpO2, and body temperature return to pre-RSV
    disease level.
    − Need for and duration of non-invasive ventilator support (eg,
    continuous positive airway pressure) and/or invasive ventilator support
    (eg, endotracheal-mechanical ventilation or mechanical ventilation via
    tracheostomy).
    − Time to return to pre-RSV functional status (Katz ADL score).
    − Need for hydration and feeding by intravenous catheter/nasogastric
    tube.
    − Time to clinical stability defined as the time at which the following
    criteria are all met:
    • normalization of blood oxygen level (return to baseline; by pulse
    oximetry) without requirement of supplemental oxygen beyond baseline
    level
    • normalization of oral feeding
    • normalization of respiratory rate
    • normalization of heart rate
    − Improvement on the ordinal scale.
    − All-cause mortality.
    • RSV RNA viral load as measured by qRT-PCR of the mid-turbinate nasal
    swab specimens which will be used to determine the following:
    − Viral load over time.
    − Peak viral load, time to peak viral load, rate of decline of viral load,
    and time to RSV RNA being undetectable.
    − Proportion of subjects with undetectable viral load at each time point.
    − The RSV RNA viral load AUC from immediately prior to first dose of
    study drug (baseline) until Day 7 (secondary for Part 1 only).
    − RSV RNA viral load AUC from immediately prior to first dose of study
    drug (baseline) until Day 10 and until Day 14.
    − RSV RNA viral load AUC in subjects assigned to a longer dosing
    duration, if dosing duration is increased by the Independent Data
    Monitoring Committee (IDMC), from baseline until 1 day after the last
    dose of study drug (Part 2 only).
    • Sequence changes (postbaseline) in the RSV polymerase L-gene and
    other regions (only if no mutations are seen in the L-gene) of the RSV
    genome compared with baseline sequences.
    • Safety/tolerability including adverse events (AEs), physical
    examinations, vital signs, electrocardiograms (ECGs), and clinical
    laboratory results.
    • Population-derived PK parameters of ALS-008112
    E.5.2.1Timepoint(s) of evaluation of this end point
    As described in the endpoints
    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 No
    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 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 Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    France
    Germany
    Hong Kong
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    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
    Last Subject Last Visit
    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 months5
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days17
    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: 97
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 119
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    See study protocol
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 216
    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)
    Patients will not receive IP after they have completed the trial and will be expected to get standard of care.
    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 Decision2016-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-16
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA