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    Summary
    EudraCT Number:2016-003642-93
    Sponsor's Protocol Code Number:53718678RSV2002
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2018-11-19
    Trial 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 number2016-003642-93
    A.3Full title of the trial
    A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children ≥28 Days and ≤3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children ≥28 Days and ≤3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection
    A.4.1Sponsor's protocol code number53718678RSV2002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/118/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Sciences Ireland UC
    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 Sciences Ireland UC
    B.4.2CountryIreland
    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 pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 (0)71 524 2166
    B.5.5Fax number+31 (0)71 524 2110
    B.5.6E-mailclinicaltrialsEU@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 nameJNJ-53718678-ZCL
    D.3.2Product code JNJ-53718678-ZCL
    D.3.4Pharmaceutical form Powder and solvent for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNJNJ-53718678-ZCL
    D.3.9.2Current sponsor codeJNJ-53718678-ZCL
    D.3.9.4EV Substance CodeSUB166668
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number23
    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 placeboPowder and solvent for oral suspension
    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
    Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection
    E.1.1.1Medical condition in easily understood language
    Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus 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 LLT
    E.1.2Classification code 10066740
    E.1.2Term Acute respiratory tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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
    To establish antiviral activity of JNJ-53718678 as measured by respiratory syncytial virus(RSV) viral load in nasal swab samples by a quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in children ≥28 days and ≤3 years of age with RSV disease.
    E.2.2Secondary objectives of the trial
    To evaluate in children ≥28 days and ≤3 years of age with RSV disease:
    ● the dose-response relationship for antiviral activity of JNJ-53718678
    ● the impact of JNJ-53718678 on the clinical course of RSV infection
    ● the safety and tolerability of JNJ-53718678 after repeated oral doses
    ● the pharmacokinetics (PK) of JNJ-53718678 after repeated oral doses
    ● medical resource utilization

    For all secondary objectives, please refer to the protocol
    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. The subject is a boy or girl ≥28 days and ≤3 years at the time of consent.
    2. Each subject’s legally acceptable representative (ie, parent(s)/legal guardian) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing for their child to participate in the study, is willing for their child to remain in the hospital until at least Day 2 (even if not clinically indicated; Cohort 1 only), and is willing/able to adhere to the lifestyle restrictions specified in the protocol and study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/site staff.
    Note: Prior to signing the main consent form for the study, subject’s legally acceptable representative may specifically allow for the collection and testing of nasal mid - turbinate swab by signing the pre-screening (diagnostic) ICF. This is not required if a positive RSV diagnostic result based on a local SOC sample collected within 48 hours prior to anticipated randomization is available and used for determining study eligibility.
    3. The subject has been diagnosed with RSV infection using a preferably rapid polymerase chain reaction (PCR) or other molecular-based diagnostic assay (preferred) or rapid-antigen-detection assay.
    Note: If a subject had a positive similar RSV diagnostic test from another stud y for which (s)he was otherwise ineligible or a SOC test within 24 hours prior to start of screening and meets all eligibility criteria for inclusion in this study, this diagnostic test result can be used for confirmation of eligibility. Randomization should occur within 24 hours after start of screening or within 48 hours after collection of the SOC sample used for local RSV diagnosis, whichever comes first.
    Note: If a rapid-antigen-detection assay is used as part of SOC or study specifically (with the main study ICF or with the diagnostic ICF having been signed), the remainder of the screening sample used for the RSV diagnostic testing should be sent to the central laboratory for additional virologic analyses, as applicable.
    4. The subject has an acute respiratory illness during which (s)he experienced a period of apnea
    OR
    The subject has an acute respiratory illness with at least 1 of the signs/symptoms listed in each of the following categories within 24 hours prior to start of screening and at screening, as evaluated by the investigator:
    ● nasal congestion, rhinorrhea, pharyngitis, or otitis media; AND
    ● increased respiratory effort (as evidenced by subcostal, intercostal or tracheosternal retractions, grunting, head bobbing, nasal flaring or tachypnea), abnormal breathing sounds (wheezing, rales or rhonchi), cyanosis or cough; AND
    ● feeding difficulties, defined as <75% intake of normal food amounts; dehydration; fever; disturbed sleep or disturbed activity level (irritable/restless/agitated/less responsive).
    5. The time of onset of RSV symptoms to the anticipated time of randomization must be ≤5 days. Onset of symptoms is defined as the time of the day (or part of the day if time of the day cannot be specified) the parent(s)/caregiver(s) became(s) aware of the first sign and/or symptom consistent with respiratory or systemic/general manifestation of symptoms of RSV infection. The time of symptom onset has to be assessed as accurately as possible.
    Note: Subjects with symptom onset ≤3 days before randomization must account for at least 50% of all enrolled subjects in Cohorts 1 and 2, at the time of all different planned analyses.
    For all inclusion criteria, please refer to the protocol pages 73-74.
    E.4Principal exclusion criteria
    Any potential subject who meets any of the following criteria will be excluded from participating in the study:
    1. The subject is <3 months postnatal age at screening and was born prematurely (ie, <37 weeks and 0 days of gestation).
    2. The subject weights <2.4 kilogram (kg) or ≥16.8 kg
    3. The subject had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study.
    4. The subject has major congenital anomalies or known cytogenetic or metabolic disorders other than the ones allowed above.
    Note: Isolated open ductus arteriosus and open foramen ovale are not exclusionary as these are not considered major anomalies. Subjects with congenital heart disease, cystic fibrosis, congenital diaphragmatic hernia, or Down Syndrome are allowed to participate.
    5. The subject is considered by the investigator to be immunocompromised within the past 12 months, whether due to underlying medical condition (eg, malignancy or genetic disorder other than immunoglobulin A deficiency, or known human immunodeficiency virus [HIV] infection) or medical therapy (eg, immunomodulators other than corticosteroids for the treatment of comorbidities, chemotherapy, radiation, stem cell or solid organ transplant).
    For all exclusion criteria, please refer to the protocol pages 74-75.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the RSV viral load area under the curve (AUC) from immediately prior to first dose of study drug through Day 5 derived from the RSV viral load as measured by a qRT-PCR assay in nasal swabs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through Day 5
    E.5.2Secondary end point(s)
    1. Virologic parameters derived from the RSV viral load as measured by a qRT-PCR assay in nasal swabs including:
    a) RSV viral load and change from baseline over time
    b) RSV viral load AUC from immediately prior to first dose of study drug (baseline) through Day 3, Day 8, and Day 14
    c) time to undetectable RSV viral load
    d) proportion of subjects with undetectable RSV viral load at each timepoint throughout the study
    2. Clinical course related endpoints -
    In hospitalized subjects and outpatients (these endpoints will be based on the Pediatric RSV Electronic Severity and Outcome Rating System [PRESORS] assessed throughout the study by parent(s)/caregiver(s) (parent[s]/caregiver[s] PRESORS) and by the investigator (clinician PRESORS) during scheduled visits):
    a) duration and severity of signs and symptoms of RSV disease
    b) change from baseline in parent(s)/caregiver(s) PRESORS scores (worsening or
    improvement)
    c) change from baseline in clinician PRESORS scores (worsening or improvement)
    d) time to resolution (ie, to none or mild) of RSV symptoms
    e) time to improvement based on general questions on overall health
    f) proportion of subjects with improvement or worsening of RSV disease based on general questions on overall health
    g) time to return to pre-RSV health as rated by the parent(s)/caregiver(s)
    In hospitalized subjects only:
    h) time to age-adjusted normal values for otherwise healthy and to pre-RSV infection status for subjects with (a) risk factor(s) for severe RSV disease, for heart rate, respiratory rate, and/or blood oxygen level (ie, without requirement of supplemental oxygen compared with pre-RSV infection status)
    i) time to discharge (from initial admission and from initiation of treatment)
    j) time to clinical stability, with clinical stability evaluated by the investigator (from initial admission and from initiation of treatment)
    3. Safety and tolerability, as assessed by adverse events (AEs), clinical laboratory testing, electrocardiograms (ECGs), vital signs, throughout the study
    4. PK parameters of JNJ-53718678, as determined by population PK (popPK) modeling
    5. Medical resource utilization
    For all secondary endpoints, please refer to the protocol
    E.5.2.1Timepoint(s) of evaluation of this end point
    1a, 1c and 1d. Throughout the study
    1b. Through Day (D)3, D8, and D14
    2a to 2j and 3. Throughout the study
    4. D1, D2 (Cohort 1), D3, D8 (Cohort 2)
    5 Throughout the study

    For all timepoints, please refer to the protocol
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker analyses, Pharmacokinetic/Pharmacodynamic Relationships, Medical Resource Utilization Analyses, Acceptability and Palatability
    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 EEA77
    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
    Belgium
    Brazil
    Bulgaria
    Canada
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Democratic People's Republic of
    Malaysia
    Mexico
    Poland
    Russian Federation
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    Turkey
    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
    LPLV
    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 months2
    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 months2
    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: 444
    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: 429
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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
    Subjects between ≥28 days and ≤3 years at the time of consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 159
    F.4.2.2In the whole clinical trial 372
    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 Decision2019-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-08
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    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
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