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    Summary
    EudraCT Number:2016-003642-93
    Sponsor's Protocol Code Number:53718678RSV2002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedItaly - Italian Medicines 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 between 28 Days and 3 Years of Age (limits included), With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection
    Uno studio di fase 2, in doppio cieco, controllato con placebo, per valutare l’attività antivirale, gli esiti clinici, la sicurezza, la tollerabilità e i rapporti tra farmacocinetica e farmacodinamica di diverse dosi di JNJ-53718678 in bambini di età compresa tra 28 giorni e 3 anni (estremi compresi), affetti da infezione acuta delle vie respiratorie causata dal virus respiratorio sinciziale.
    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 between 28 Days and 3 Years of Age (limits included), With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection
    Uno studio di fase 2, in doppio cieco, controllato con placebo, per valutare l’attività antivirale, gli esiti clinici, la sicurezza, la tollerabilità e i rapporti tra farmacocinetica e farmacodinamica di diverse dosi di JNJ-53718678 in bambini di età compresa tra 28 giorni e 3 anni (estremi compresi), affetti da infezione acuta delle vie respiratorie causata dal virus respiratorio sinciziale.
    A.3.2Name or abbreviated title of the trial where available
    CROCuS
    CROCuS
    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/081/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Sciences Ireland Unlimited Company
    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.4.1Name of organisation providing supportJanssen Cilag SpA
    B.4.2CountryItaly
    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 number0031715242166
    B.5.5Fax number00310715242110
    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
    D.3.2Product code [JNJ-53718678]
    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.3.9.2Current sponsor codeJNJ-53718678
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 solution
    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
    Infezione acuta delle vie respiratorie causata dal virus respiratorio sinciziale.
    E.1.1.1Medical condition in easily understood language
    Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection
    Infezione acuta delle vie respiratorie causata dal virus respiratorio sinciziale.
    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 between 28 Days and 3 Years of Age (limits included) with RSV disease.
    L’obiettivo primario è determinare l’attività antivirale di JNJ 53718678 misurata con la carica virale VRS nei campioni nasali mediante un test qRT PCR (reazione a catena della polimerasi-trascrittasi inversa quantitativa in tempo reale) in bambini di età compresa tra 28 giorni e 3 anni (estremi compresi), affetti da malattia da VRS.
    E.2.2Secondary objectives of the trial
    To evaluate in Children between 28 Days and 3 Years of Age (limits included) 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
    Gli obiettivi secondari consistono nella valutazione in bambini di età tra 28 giorni e 3 anni (estremi compresi), affetti da VRS:
    • della relazione dose risposta per l’attività antivirale di JNJ-53718678
    • dell’impatto di JNJ-53718678 sul decorso clinico dell’infezione da VRS
    • della sicurezza e della tollerabilità di JNJ-53718678 in seguito a dosi orali ripetute
    • della farmacocinetica (PK) di JNJ-53718678 in seguito a dosi orali ripetute
    • dell’utilizzo delle risorse mediche

    Per tutti gli obiettivi secondari, si prega di far riferimento al protocollo.
    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 between 28 Days and 3 Years of Age (limits included) 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 mid-turbinate or nasopharyngeal swabs are collected for diagnostic testing per local standard of care (SOC).
    3. The subject has been diagnosed with RSV infection using a polymerase chain reaction (PCR)-based (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 the results of the SOC RSV positivity test became available, 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 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 less or=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 less or=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.
    1.Il soggetto è un bambino o una bambina di età compresa tra 28 giorni e 3 anni (estremi compresi), al momento del consenso. 2.Il rappresentante legale autorizzato(ossia uno o entrambi i genitori/il tutore legale) deve firmare un modulo di consenso informato (ICF)indicando di aver compreso lo scopo dello studio e le procedure previste, di acconsentire alla partecipazione del/della bambino/a, di acconsentire alla permanenza in ospedale del/della bambino/a fino ad almeno il Giorno 2(anche se non clinicamente indicato; solo Coorte 1)e di accettare/essere in grado di rispettare i divieti e le restrizioni specificati nel protocollo e le procedure dello studio e le valutazioni a carico del/dei genitore/i/caregiver e di quelle a carico dello sperimentatore/personale del centro. Nota:Prima di firmare il consenso principale,il rappresentante legale autorizzato potrà consentire specificatamente il prelievo e l’esame del tampone nasale dei turbinati medi firmando il modulo di consenso informato pre screening (diagnostico). Questo non è richiesto se i tamponi nasali dei turbinati medi o nasofaringei vengono prelevati per esami diagnostici in accordo allo standard di cura previsto localmente. 3.Al soggetto è stata diagnosticata un’infezione da VRS mediante preferibilmente un test rapido su base PCR o un'altra analisi diagnostica a base molecolare(preferito) o un test rapido di rilevamento dell'antigene.4.Il soggetto presenta una malattia respiratoria acuta durante la quale ha sperimentato un periodo di apnea OPPURE Il soggetto presenta una malattia respiratoria acuta con almeno1 segno/sintomo tra quelli elencati in ognuna delle seguenti categorie nell’arco di 24 ore prima dell’inizio dello screening e al momento dello screening, secondo la valutazione dello sperimentatore: e congestione nasale, rinorrea, faringite oppure otite media; e aumento dello sforzo respiratorio (evidenziato da retrazioni subcostali, intercostali o tracheosternale, dondolamento del capo, allargamento delle narici o tachipnea), rumori respiratori anomali (respiro affannoso, rantoli o ronchi), cianosi o tosse; e difficoltà di nutrizione, intesa come assunzione inferiore al 75% della normale quantità di cibo; disidratazione; febbre; disturbi del sonno o livello di attività disturbato (irritabile/irrequieto/agitato/minore reattività). 5.Il momento di esordio dei sintomi VRS dalla data di randomizzazione anticipata deve essere inferiore o =5 giorni. Con esordio dei sintomi si intende il momento del giorno (o parte del giorno se il momento del giorno non può essere specificato) in cui il/i genitore/i/caregiver nota/notano il primo segno e/o sintomo coerente con una manifestazione sistemica/generale dei sintomi da infezione da VRS. Il momento di esordio dei sintomi deve essere valutato nel modo più accurato possibile. Nota:I soggetti con esordio dei sintomi minore o=3 giorni prima della randomizzazione devono ammontare ad almeno il 50% di tutti i soggetti nella Coorte 1 e nella Coorte 2al momento di tutte le diverse analisi programmate.Per tutti i criteri di inclusione, si prega di far riferimento al protocollo, pagine 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).
    6. The subject has other clinically significant abnormal ECG findings not consistent with the present risk factor for severe RSV disease (if applicable) in the study population, as judged by the investigator based on the machine read ECG results at screening.
    7. The subject has a QTcF interval >450 ms per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate ECG recording during screening.

    For all exclusion criteria, please refer to the protocol pages 74-75.
    1. Il soggetto ha un’età di <3 mesi postnatali allo screening ed è nato prematuro (ossia <37 settimane e 0 giorni di gestazione).
    2. Il soggetto ha un peso inferiore a 2.4 chilogrammi (kg) o superiore o = a 16.8 kg
    3. Il soggetto ha subito un intervento di chirurgia maggiore nell’arco dei 28 giorni precedenti alla randomizzazione o ha in programma un intervento di chirurgia maggiore nel corso dello studio.
    4. Il soggetto presenta anomalie congenite gravi o ha disordini citogenetici o metabolici noti diversi da quelli consentiti qui sopra.
    Nota: il dotto arterioso pervio isolato e il forame ovale pervio non costituiscono un criterio di esclusione in quanto non sono considerati gravi anomalie. Ai soggetti affetti da cardiopatia, fibrosi cistica, ernia diaframmatica congenita o sindrome di Down è consentita la partecipazione.
    5. Il soggetto è considerato dallo sperimentatore immunocompromesso negli ultimi 12 mesi, a causa di una condizione medica di base (ad es., neoplasia maligna o disturbo genetico diverso da immunodeficienza A oppure infezione da virus dell'immunodeficienza umana [HIV] nota) o di una terapia medica (ad es., immunomodulatori diversi dai corticosteroidi assunti per il trattamento delle comorbidità, chemioterapia, radioterapia, trapianto di cellule staminali o di organi solidi).
    6.Il soggetto presenta altri risultati ECG anormali clinicamente significativi non coerenti con l'attuale fattore di rischio per la malattia severa da VRS (se applicabile) nella popolazione dello studio, come giudicato dallo sperimentatore in base ai risultati dell'ECG letti dallo strumento allo screening.
    7. Il soggetto ha un intervallo QT corretto per la frequenza cardiaca secondo l'intervallo della formula di Fridericia (QTcF)> 450 ms in base al risultato del parametro letto dallo strumento (media del triplicato) confermato dalla ripetuta registrazione ECG durante lo screening.

    Per tutti i criteri di esclusione, si prega di far riferimento al protocollo, pagine 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.
    L’endpoint primario di efficacia è l’area di carica virale VRS sotto la curva (AUC) da immediatamente prima alla prima dose di farmaco sperimentale al Giorno 5 ricavata dalla carica virale VRS e misurata con il test qRT-PCR sui tamponi nasali.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through Day 5
    Al giorno 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
    1.Parametri virologici derivati dalla carica virale VRS misurata con un test qRT PCR sui tamponi nasali, compresi:
    a)carica virale VRS e variazione nel tempo dal basale;
    b)AUC della carica virale VRS dal momento immediatamente precedente alla prima dose di farmaco sperimentale (basale) fino al Giorno 3, Giorno 8 e Giorno 14;
    c)tempo alla non rilevabilità della carica virale del VRS;
    d)percentuale di soggetti con carica virale del VRS non rilevabile in ogni momento nel corso dell’intero studio.
    2.Endpoint relativi al decorso clinico-in soggetti ricoverati e in regime ambulatoriale (i seguenti endpoint saranno basati sul Sistema elettronico di valutazione della gravità e degli esiti dell’infezione da VRS in età pediatrica (PRESORS), rilevati nel corso dell’intero studio dal/dai genitore/i/caregiver (PRESORS genitore/genitori/caregiver) e dallo sperimentatore (PRESORS clinico) durante le visite programmate:
    a)durata e gravità dei segni e dei sintomi della malattia da VRS;
    b)variazione dei punteggi PRESORS genitore/i/caregiver dal basale (peggioramento o miglioramento); c)variazione dei punteggi PRESORS clinico dal basale (peggioramento o miglioramento); d)tempo alla risoluzione dei sintomi da VRS (ossia nessuno o lieve); e)tempo al miglioramento sulla base di domande sulla salute in generale;
    f)percentuale di soggetti con miglioramento o peggioramento della malattia da VRS sulla base di domande sulla salute in generale;
    g)tempo al ritorno dello stato precedente al VRS secondo la valutazione del/dei genitore/i/caregiver.
    Solo nei soggetti ricoverati:
    h)tempo al ritorno ai valori normali adattati in base all'età per condizioni di salute buone e allo stato precedente all’infezione da VRS in soggetti con fattore/fattori di rischio per malattia da VRS grave, frequenza cardiaca, frequenza respiratoria e/o livello di ossigeno nel sangue (ossia senza requisito di ossigeno supplementare in confronto allo stato precedente all’infezione da VRS);
    i)tempo alla dimissione (dal ricovero iniziale e dall’inizio del trattamento);
    j)tempo alla stabilità clinica, misurata dallo sperimentatore (dal ricovero iniziale e dall’inizio del trattamento).
    3. Sicurezza e tollerabilità, valutate dagli eventi avversi (AE), test clinici di laboratorio, elettrocardiogrammi (ECG), segni vitali, nel corso dell’intero studio
    4. Parametri PK di JNJ-53718678 come determinati dal modello PK di popolazione (popPK)
    5.Utilizzo delle risorse mediche
    Per tutti gli end points, si prega di far riferimento al protocollo.
    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
    1a, 1c e 1d. Per tutta la durata dello studio
    1b. Fino al giorno (D)3, D8, e D14
    Da 2a a 2j e 3. Per tutta la durata dello studio
    4. D1, D2 (Coorte 1), D3, D8 (Coorte 2)
    5 Per tutta la durata dello studio
    Per tutti i tempi di rilevazione, si prega di far riferimento al protocollo.
    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
    Analisi dei Biomarcatori, Relazioni tra Farmacocinetica e Farmacodinamica, Analisi sull'utilizzo delle risorse mediche, Accettabilità e Gradevolezza
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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
    Argentina
    Belgium
    Brazil
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, 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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days19
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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 of Age (limits included) at the time of consent
    Soggetti di età compresa tra 28 giorni e 3 anni (estremi compresi), alla firma del consenso
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 159
    F.4.2.2In the whole clinical trial 444
    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
    nessuno
    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 Decision2019-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-25
    P. End of Trial
    P.End of Trial StatusOngoing
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