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    The EU Clinical Trials Register currently displays   43936   clinical trials with a EudraCT protocol, of which   7310   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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    EudraCT Number:2017-001862-56
    Sponsor's Protocol Code Number:64041575RSV2004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-03-12
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-001862-56
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected with Respiratory Syncytial Virus
    Studio di fase 2, randomizzato, in doppio cieco, controllato con placebo, per valutare attività antivirale, risultati clinici, sicurezza, tollerabilità e farmacocinetica di regimi di lumicitabina (JNJ-64041575) somministrato per via orale nei neonati e nei bambini ricoverati di età compresa tra i 28 giorni e 36 mesi, affetti da Virus Respiratorio Sinciziale.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the effects of lumicitabine (JNJ-64041575) in hospitalized infants and children infected with Respiratory Syncytial Virus (RSV)
    A study to investigate the effects of lumicitabine (JNJ-64041575) in hospitalized infants and children infected with Respiratory Syncytial Virus (RSV)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number64041575RSV2004
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/29/2017
    B. Sponsor Information
    B.Sponsor: 1
    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 Research & Development, LLC
    B.4.2CountryUnited States
    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 code2333CM
    B.5.4Telephone number00
    B.5.5Fax number00
    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 nameLumicitabine
    D.3.2Product code JNJ-64041575
    D.3.4Pharmaceutical form Powder and solvent for oral solution
    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 INNLumicitabine
    D.3.9.1CAS number 1445385-02-3
    D.3.9.2Current sponsor codeJNJ-64041575-AAA
    D.3.9.3Other descriptive nameALS-008176
    D.3.9.4EV Substance CodeSUB184536
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Respiratory syncytial virus infection
    Infezione da virus respiratorio sinciziale
    E.1.1.1Medical condition in easily understood language
    Respiratory virus infection
    Infezione respiratoria da virus
    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
    To determine in hospitalized infants and children who are infected with RSV the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using qRT-PCR.
    L’obiettivo primario è determinare la relazione dose-risposta di regimi multipli di lumicitabina sull’attività antivirale in base alla diffusione nasale di RSV mediante reazione a catena della polimerasi-trascrittasi inversa quantitativa in tempo reale (qRT-PCR) in neonati e bambini ricoverati affetti da RSV.
    E.2.2Secondary objectives of the trial
    To determine in hospitalized infants and children who are infected with RSV:
    • The safety and tolerability of lumicitabine.
    • The PK of JNJ-63549109 in whole blood.
    • The impact of lumicitabine on the clinical course of RSV infection.
    • The impact of lumicitabine on the duration and severity of signs and symptoms of RSV infection as assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS) questionnaire completed by the clinician in the electronic clinical outcome assessment (eCOA) device.
    • The impact of lumicitabine on the time to undetectable nasal RSV viral load.
    • The impact of lumicitabine on the emergence of RSV strains with resistance-associated mutations.
    • The relationship between the PK of JNJ-63549109 and the PD (antiviral activity, clinical symptoms, and selected safety parameters) after single (LD) and repeated oral dosing (MD) of lumicitabine.
    • The acceptability and palatability of the lumicitabine formulation.
    Determinare in neonati e bambini ricoverati con infezione da RSV:
    • La sicurezza e la tollerabilità di lumicitabina.
    • La farmacocinetica (PK) di JNJ-63549109 nel sangue intero.
    • L’impatto della lumicitabina sul decorso clinico dell’infezione da RSV.
    • L’impatto della lumicitabina sulla durata e la gravità di segni e sintomi dell’infezione da RSV valutati mediante il questionario Sistema elettronico di valutazione della gravità e degli esiti dell’infezione da RSV in età pediatrica (PRESORS) compilato dal medico nel dispositivo elettronico di valutazione degli esiti clinici (eCOA).
    • L’impatto della lumicitabina sul tempo al raggiungimento della carica virale di RSV nasale non rilevabile.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female infants and children ≥28 days to ≤36 months of age, defined at the time of randomization.
    • Subjects hospitalized (or in ER) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization.
    • Subjects diagnosed with RSV infection using a PCR-based molecular diagnostic assay, with or without coinfection with another respiratory pathogen (respiratory virus or bacteria).
    • Subjects who have 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.
    • With the exception of the symptoms related to the RSV infection or defined comorbid condition for severe RSV disease (prematurity at birth [subject’s gestational age was <37 weeks; for infants <1 year old at randomization], bronchopulmonary dysplasia,congenital heart disease, other congenital diseases, Down syndrome, neuromuscular impairment, or cystic fibrosis), subjects must be medically stable on the basis of physical examination, medical history, vital signs/SpO2, and ECG performed at screening.
    • The subject’s estimated glomerular filtration rate (eGFR) is not below the lower limit of normal for the subject’s age (Schwartz equation calculation).
    1. Neonati e bambini di ambo i sessi di età compresa tra ≥28 giorni e ≤36 mesi, definita al momento della randomizzazione.
    2. Soggetti ricoverati in ospedale (o al PS) al momento della randomizzazione e che probabilmente non saranno dimessi nelle prime 24 ore dopo la randomizzazione.
    3. Soggetti con diagnosi di infezione da RSV formulata utilizzando un saggio diagnostico molecolare basato sulla PCR, con o senza coinfezione con un altro patogeno delle vie respiratorie (virus o batteri respiratori).
    4. Soggetti affetti da malattia respiratoria acuta con segni e sintomi coerenti con un’infezione virale (es. febbre, tosse, congestione nasale, naso che cola, mal di gola, mialgia, letargia, respiro affannoso o sibilo), con esordio ≤5 giorni dal momento previsto per la randomizzazione. L’esordio dei sintomi è definito come la prima volta (entro 1 ora) in cui il/i genitore/i/caregiver viene/vengono a conoscenza di sintomi respiratori o sistemici di infezione da RSV.
    5. Ad eccezione dei sintomi correlati all’infezione da RSV o ad una specifica comorbilità definita per malattia grave da RSV (prematurità alla nascita [l’età gestazionale del soggetto era <37 settimane; per i neonati di età <1 anno alla randomizzazione], displasia broncopolmonare, cardiopatia congenita, altre malattie congenite, sindrome di Down, deterioramento neuromuscolare o fibrosi cistica), i soggetti devono essere clinicamente stabili sulla base di esame obiettivo, anamnesi medica, parametri vitali/SpO2 ed ECG eseguiti allo screening. In caso di anomalie, queste dovranno essere coerenti con la condizione sottostante nella popolazione di studio e/o con l’infezione da RSV. Tale determinazione deve essere registrata nei documenti originali del soggetto e avviata dallo sperimentatore. Ai soggetti con comorbilità sarà consentito arruolarsi dopo che l’IDMC avrà esaminato i dati di PK e sicurezza della dose più alta che sarà usata in questo studio e dopo che l’IDMC avrà suggerito l’apertura del reclutamento in questo gruppo. I centri saranno informati nel caso in cui la restrizione venga revocata.
    . La velocità di filtrazione glomerulare stimata (eGFR) del soggetto non è al di sotto del limite inferiore della norma per l’età del soggetto (per il calcolo dell’equazione di Schwartz, si veda l’Allegato 3).
    E.4Principal exclusion criteria
    • Subjects who are not expected to survive for more than 48 hours.
    • Subjects who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization.
    • Subjects who received (within 12 months prior to screening) or who are currently on a waiting list for a bone marrow, stem cell, or solid organ transplant, who received radiation or chemotherapy, or who are currently taking immunosuppressive medication.
    • Subjects who have a known or suspected immunodeficiency (except immunoglobulin A [IgA] deficiency), such as a known human immunodeficiency virus infection.
    • Subjects who have a history of or concurrent illness (beyond a defined comorbid condition for severe RSV disease) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject, or that could prevent, limit, or confound the protocol-specified assessments.
    • Subjects aged ≥28 days to 35 days with <8.0 g/dL (Grade 3) hemoglobin or a cardiac failure secondary to anemia (Grade 4) and subjects aged ≥36 days to 36 months with <7.0 g/dL (Grade 3) hemoglobin or cardiac failure secondary to anemia (Grade 4).
    • Subjects aged ≥28 days to 60 days with <899/mm3 absolute neutrophil count) and subjects aged ≥61 days to ≤36 months with <399/mm3 absolute neutrophil count.
    • Subjects aged ≥28 days to ≤36 months with <49,999/mm3 platelet count (Grade 3/4).
    . Soggetti con aspettativa di vita non superiore a 48 ore.
    . Soggetti che sono stati sottoposti a un intervento chirurgico toracico o addominale maggiore nelle 6 settimane precedenti la randomizzazione.
    . Soggetti che hanno ricevuto (nei 12 mesi precedenti lo screening) o che attualmente sono in lista di attesa per un trapianto di midollo osseo, cellule staminali od organo solido, che hanno ricevuto radioterapia o chemioterapia (nei 12 mesi precedenti lo screening) o che attualmente assumono farmaci immunosoppressivi (fare riferimento alla Sezione 8, Terapia pre-studio e concomitante).
    . Soggetti che presentano un’immunodeficienza nota o sospetta (escluso il deficit di immunoglobulina A [IgA]), come ad esempio un’infezione nota da virus dell’immunodeficienza umana.
    . Soggetti con un’anamnesi di o affetti da malattia concomitante (oltre a una comorbilità specifica per malattia grave da RSV) che, secondo il parere dello sperimentatore, potrebbe confondere i risultati dello studio o comportare un rischio aggiuntivo per il soggetto nella somministrazione del farmaco dello studio, o che potrebbe impedire, limitare o confondere le valutazioni specificate dal protocollo come l’insufficienza epatica o renale; malattia cardiaca, vascolare, polmonare, gastrointestinale, endocrina, neurologica, ematologica, reumatologica, metabolica o genetica significativa che comporti immunosoppressione. Tra queste possono esservi, senza limitazione, batteriemia, disfunzione d’organo o altre comorbilità gravi.
    . Soggetti di età compresa tra ≥28 giorni e 35 giorni con emoglobina <8,0 g/dl (Grado 3) o con un’insufficienza cardiaca secondaria ad anemia (Grado 4) e soggetti di età compresa tra ≥36 giorni e 36 mesi con emoglobina <7,0 g/dl (Grado 3) o insufficienza cardiaca secondaria ad anemia (Grado 4).
    . Soggetti di età compresa tra ≥28 giorni e 60 giorni con conta neutrofilica assoluta <899/mm3 e soggetti di età compresa tra ≥61 giorni e ≤36 mesi con conta neutrofilica assoluta <399/mm3.
    . Soggetti di età compresa tra ≥28 giorni e ≤36 mesi con conta piastrinica <49.999/mm3 (Grado 3/4).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is RSV RNA log10 viral load (measured by qRT-PCR assay in the mid-turbinate nasal swab specimens) AUC immediately prior to first dose of study drug (baseline) over 7 days.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Samples for the determination of RSV viral load will be taken as close as possible and before the LD on Day 1 and once daily at approximately the same time each day prior to study drug administration between Day 2 and Day 6 (whether hospitalized or not), and at the Day 7, Day 10, Day 14, and Day 28 visits.
    E.5.2Secondary end point(s)
    • Safety/tolerability including adverse events (AEs), physical examinations, vital signs/peripheral capillary oxygen saturation (SpO2), electrocardiogram (ECG), and clinical laboratory results.
    • PK parameters of JNJ-63549109.
    • RSV clinical course endpoints:
    o Length of hospital stay from admission to discharge and to readiness for discharge and from study treatment initiation to discharge and to readiness for discharge, with readiness for discharge evaluated by the investigator.
    o Requirement for and duration of intensive care unit (ICU) stay.
    o Requirement for and duration of oxygen supplementation/noninvasive mechanical ventilation support and/or invasive mechanical ventilation support above pre-RSV infection status.
    o Time to no longer requiring supplemental oxygen above pre-RSV infection status.
    o Time to clinical stability defined as the time from initiation of study treatment until the time at which the following criteria are met: return to pre-RSV infection status (hereafter referred to as “normalization”) of blood oxygen level (ie, without additional requirement of supplemental oxygen compared with pre-RSV infection status), normalization of oral feeding, normalization of respiratory rate, and normalization of heart rate.
    o Time from initiation of study treatment until SpO2 ≥93% on room air among subjects who were not on supplemental oxygen prior to the onset of respiratory symptoms.
    o Time to respiratory rate, SpO2, and body temperature return to pre-RSV infection status.
    o Incidence of acute otitis media (defined by the investigator).
    • The duration and severity of signs and symptoms of RSV infection as assessed by the PRESORS questionnaire completed by the clinician in the eCOA device.
    • RSV viral load as measured by qRT-PCR in the mid-turbinate nasal swab specimens, which will be used to determine the following:
    o RSV viral load over time.
    o Peak viral load, time to peak viral load, rate of decline of viral load, and time to RSV RNA being undetectable.
    o Proportion of subjects with undetectable RSV viral load at each timepoint.
    o RSV viral load AUC from immediately prior to first dose of study drug (baseline) until Day 10 and until Day 14.
    o RSV viral load AUC in subjects assigned to a longer dosing duration, if dosing duration is increased by the IDMC, from baseline until 1 day (+2 days) after the last dose of study drug.
    • Sequence changes (postbaseline) in the RSV polymerase L-gene and other regions (if warranted) of the RSV genome compared with baseline sequences.
    • Acceptability and palatability of the lumicitabine formulation as assessed by the parent(s)/caregiver(s) eCOA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and tolerability: evaluated throughout the study.

    PK sampling: Post Dose 1 (0.25-2h), Post Dose 2 (0.5-1h OR 7h) and Day 7 visit.

    Clinical evaluation and clinician eCOA: Screening and twice daily for the
    entire duration of hospitalization. After hospital discharge: at the Day 7, Day 10, Day 14, and Day 28 visits.

    Nasal swabs [RSV viral load and viral resistance (genome sequencing)]: before the LD on Day 1, once daily prior to study drug administration between Day 2 and Day 6 (whether hospitalized or not), and at the Day 7, Day 10, Day 14, and Day 28 visits.

    Parent(s)/caregiver(s) eCOA: Screening and twice daily for the entire duration of hospitalization. After hospital discharge: twice daily until the Day 14 visit, and once daily up to the Day 28 visit.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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. 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    New Zealand
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days12
    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: 1
    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. of subjects for this age range: 140
    F.1.1.5Children (2-11years) Yes
    F. of subjects for this age range: 40
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 77
    F.4.2.2In the whole clinical trial 180
    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)
    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 Decision2018-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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