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    Summary
    EudraCT Number:2015-002003-28
    Sponsor's Protocol Code Number:53718678RSV1005
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-10-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-002003-28
    A.3Full title of the trial
    A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with RSV infection
    Estudio de fase 1b aleatorizado, parcialmente doble ciego, controlado con placebo para determinar la farmacocinética, seguridad y tolerabilidad de múltiples dosis de JNJ-53718678 administrado por vía oral en niños hospitalizados con infección por VRS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized with Respiratory Syncytial Virus (RSV) Infection
    Estudio para evaluar la farmacocinética, la seguridad y la tolerabilidad de JNJ-53718678 administrado por vía oral a lactantes hospitalizados debido a infección por el virus respiratorio sincitial (VRS)
    A.4.1Sponsor's protocol code number53718678RSV1005
    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 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, S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressPº de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 91 7228100
    B.5.5Fax number+34 91 7228628
    B.5.6E-mailagonza45@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-AAA-G024
    D.3.4Pharmaceutical form Oral solution
    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 INNJNJ-53718678-AAA
    D.3.9.3Other descriptive nameJNJ-53718678-AAA
    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 number10
    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 nameJNJ-53718678-AAA-G025
    D.3.4Pharmaceutical form Oral solution
    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 INNJNJ-53718678-AAA
    D.3.9.3Other descriptive nameJNJ-53718678-AAA
    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 number20
    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 placeboOral 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
    Respiratory Syncytial Virus
    Virus sincitial respiratorio
    E.1.1.1Medical condition in easily understood language
    Respiratory Syncytial Virus
    Virus sincitial respiratorio
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10038717
    E.1.2Term Respiratory syncytial viral infections
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate in infants who are hospitalized with RSV infection:
    - the pharmacokinetics of JNJ-53718678 after multiple oral doses;
    - the safety and tolerability of JNJ-53718678 when administered for 7 days.
    Los objetivos principales son evaluar en los lactantes que se encuentran hospitalizados debido a una infección por el VRS:
    -La farmacocinética de JNJ-53718678 después de dosis múltiples por vía oral.
    -La seguridad y la tolerabilidad de JNJ-53718678 cuando se administra durante 7 días.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate in infants who are hospitalized with RSV infection:
    - the impact of JNJ-53718678 on the clinical course of RSV infection when administered for 7 days;
    - the antiviral activity of JNJ-53718678 when administered for 7 days.

    Exploratory Objectives:
    The exploratory objectives are to assess in infants who are hospitalized with RSV infection:
    - the relationship between the pharmacokinetics and the pharmacodynamics after repeated oral dosing of JNJ-53718678 for 7 days;
    - the evolution of viral resistance under JNJ-53718678 treatment;
    - the impact of the viral genotype on the antiviral response;
    - the clinical course of RSV during and following hospitalization based on twice daily (bid) or three times daily (tid) caregiver ratings of the severity of RSV symptoms through end of follow-up.
    Evaluar en los lactantes que se encuentran hospitalizados debido a una infección por el VRS:
    -El efecto de JNJ-53718678 administrado durante 7 días sobre la evolución clínica de la infección por el VRS, conforme evalúe el médico.
    -La actividad antivírica de JNJ-53718678 administrado durante 7 días.
    Objetivos exploratorios
    Evaluar en los lactantes que se encuentran hospitalizados debido a una infección por el VRS:
    -La relación entre la farmacocinética y la farmacodinámica después de dosis repetidas por vía oral de JNJ-53718678 durante 7 días.
    -La evolución de la resistencia vírica con el tratamiento de JNJ-53718678.
    -El efecto del genotipo vírico sobre la respuesta antivírica.
    -El efecto de JNJ-53718678 cuando se administra durante 7 días sobre la evolución clínica de la infección por el VRS durante y después de la hospitalización conforme evalúen los padres/cuidador del paciente en las evaluaciones electrónicas de resultados clínicos hasta el final del seguimiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant has presented at the hospital for suspected Respiratory Syncytial Virus (RSV) infection within 72 hours prior to Screening completion
    - Participant has been hospitalized for this suspected RSV infection
    - Participant has been diagnosed with RSV infection using a polymerase chain reaction (PCR)- based assay, preferably commercially available locally
    - Participant was born after a normal term pregnancy (greater than or equal to 37 weeks and 0 days)
    - A legally acceptable representative of the participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, are willing for their child to participate in the study, are willing for their child to remain in the hospital for the first 3 days of dosing (even if not clinically indicated), and are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
    -Participante que se haya presentado en el hospital por sospecha de infección de virus respiratorio sincitial (VRS) dentro de las 72 horas antes de la aleatoriazión
    - Participante que haya sido hospitalizado por esta sospecha de infección por VRS
    - Participante que haya sido diagnosticado con la infección por RSV usando una reacción en cadena de la polimerasa (PCR) - preferiblemente comercialmente disponible localmente
    - Participante que haya nacido después de un embarazo a término normal (mayor o igual a 37 semanas y 0 días)
    - Un representante legal del participante debe firmar un formulario de consentimiento informado (ICF), indicando que él o ella entiende el propósito y los procedimientos necesarios para el estudio, están dispuestos a que su hijo/a participe en el estudio, están dispuestos a que su hijo permanezca en el hospital durante los primeros 3 días de dosificación (incluso si no se indica clínicamente), y están dispuestos / capaces de adherirse a las prohibiciones y restricciones especificadas en los procedimientos de protocolo y de estudio
    E.4Principal exclusion criteria
    - Participant who had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study
    - Participant has major congenital anomalies or known cytogenetic disorders
    - Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection
    - Participant has known or suspected hepatitis B or C infection
    - Participant is upon current admission initially hospitalized in the Intensive care unit (ICU) and/or in need of invasive endotracheal mechanical ventilation
    - Que el Participante haya tenido una cirugía mayor dentro de los 28 días anteriores a la aleatorización o planeada una cirugía mayor en el transcurso del estudio
    - Que el Participante tenga importantes anomalías congénitas o trastornos citogenéticos conocidos
    - Que el Participante haya tenido o sospecha de inmunodeficiencia, como la infección por el virus de la inmunodeficiencia humana conocida (VIH)
    - Que el Participante haya tenido o sospechado tener infección por Hepatitis B o C.
    - Participante es el momento del ingreso corriente inicialmente hospitalizado en la unidad de cuidados intensivos (UCI) y / o con necesidad de ventilación mecánica invasiva endotraqueal
    E.5 End points
    E.5.1Primary end point(s)
    1- Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678
    2- Trough Plasma Concentration (Ctrough) of JNJ-53718678
    3- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
    4- Total Apparent Clearance (CL/F) of JNJ-53718678
    5- Apparent Volume of Distribution (Vd/F) of JNJ-53718678
    6- Number of Participants With Adverse Events
    1- Máxima concentración observada en plasma (Cmáx) de JNJ-53718678
    2- Concentración en plasma de JNJ-53718678 al final (C minima)
    3- área bajo la curva desde el tiempo cero hasta el final del intervalo de dosificación (AUCtau)
    4- total aclaramiento aparente (CL / F) de JNJ-53718678
    5- El volumen aparente de distribución (Vd / F) de JNJ-53718678
    6- Número de participantes con eventos adversos
    E.5.1.1Timepoint(s) of evaluation of this end point
    1- Days 1, 2and 3
    2- Days 1, 2and 3
    3- Days 1, 2and 3
    4- Days 1, 2and 3
    5- Days 1, 2and 3
    6- Up to Follow-up (Day 28)
    1- Días 1, 2 y 3
    2- Días 1, 2 y 3
    3- Días 1, 2 y 3
    4- Días 1, 2 y 3
    5- Días 1, 2 y 3
    6- Hasta Seguimiento (Día 28)
    E.5.2Secondary end point(s)
    1- Area Under the Viral Load-time Curve (VL AUC)
    2- Viral Load Over Time
    3- Peak Viral Load
    4- Time To Peak Viral Load
    5- Number of Participants Reaching Undetectability of virus Between First Administration of Study Drug and Day 28
    6- Total Number of Respiratory Syncytial Virus (RSV) Hospitalization Days from Admission to Discharge
    7- Total RSV Hospitalization Days with Supplemental Oxygen Requirement
    8- Total Days of RSV Intensive care unit (ICU) Stay
    9- Total Days of non-invasive ventilator support During RSV Hospitalization
    10- Total Days of Mechanical Ventilation During RSV Hospitalization
    11- Changes in Peripheral Capillary Oxygen Saturation (SpO2)
    12- Change from Baseline in Respiratory Rate
    13- Change from Baseline in Body Temperature
    14- Clinician Clinical Outcome Assessment of RSV Disease
    15- Amount of food intake
    16- Amount of water intake (hydration)
    17- Amount of Feeding by Intravenous route
    1- Area Bajo la Curva del tiempo de carga vírica (VL AUC)
    2- carga vírica a lo largo del tiempo
    3- pico de carga viral
    4- tiempo hasta el pico de carga viral
    5- proporción de pacientes que alcanza la indetectabilidad del virus entre la primera administración del fármaco del estudio y el día 28
    6- Número total de días de hospitalización por el virus respiratorio sincitial (VRS) desde el ingreso hasta el alta
    7- Número total de días de hospitalización por VRS con necesidad de oxígeno suplementario
    8- Número total de días Total de Días de estancia en la unidad de cuidados intensivos (UCI) por VRS.
    9- Número total de días de soporte ventilatorio no invasivo durante la hospitalización por RSV
    10- Número total de días de ventilación mecánica durante la hospitalización por VRS
    11- Cambios en la saturación de oxigeno periférico capilar (SpO2)
    12- cambio desde el inicio de la frecuencia respiratoria
    13- cambio desde el inicio de la temperatura corporal
    14- Evaluación de resultados clínicos clínico de la enfermedad por VRS 15- Cantidad de la ingesta de alimentos
    16- Cantidad de consumo de agua (hidratación)
    17- Cantidad de alimentación por vía intravenosa
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- Up to Follow-up (Day 28)
    2- Up to Follow-up (Day 28)
    3- Up to Follow-up (Day 28)
    4- Up to Follow-up (Day 28)
    5- Day 1 to Day 28
    6-17 - Up to Follow-up (Day 28)
    1- Hasta Seguimiento (Día 28)
    2- Hasta Seguimiento (Día 28)
    3- Hasta Seguimiento (Día 28)
    4- Hasta Seguimiento (Día 28)
    5- Día 1 al día 28
    6-17 - Hasta Seguimiento (Día 28)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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
    Tolerability
    Antiviral activity
    Tolerabilidad, actividad antiviral
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Multiple ascending dose study
    Estudio de dosis múltiple ascendente
    E.7.2Therapeutic exploratory (Phase II) No
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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
    Belgium
    Brazil
    Germany
    Italy
    Spain
    Sweden
    E.8.7Trial has a data monitoring committee No
    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
    Ultima visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months14
    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: 42
    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: 42
    F.1.1.5Children (2-11years) No
    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 are infants between 1 and 24 months
    Los sujetos son niños entre 1 y 24 meses
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 42
    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)
    See Protocol
    Ver Protocolo
    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 Decision2015-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-11-10
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