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    Summary
    EudraCT Number:2017-003252-24
    Sponsor's Protocol Code Number:53718678RSV2004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-27
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-003252-24
    A.3Full title of the trial
    A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ- 53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus
    Estudio piloto de fase 2a aleatorizado, doble ciego, controlado con placebo para investigar la actividad antiviral, los resultados clínicos, la seguridad, la tolerabilidad y la farmacocinética de dos dosis de JNJ-53718678 en pacientes adultos no hospitalizados infectados por el virus respiratorio sincitial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Determine the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 Administered at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus
    Ensayo clínico para investigar la actividad antiviral, los resultados clínicos, la seguridad, la tolerabilidad y la farmacocinética de dos dosis de JNJ-53718678 en pacientes adultos no hospitalizados infectados por el virus respiratorio sincitial.
    A.4.1Sponsor's protocol code number53718678RSV2004
    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+3491 7228100
    B.5.5Fax number+3491 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 (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.3.9.1CAS number 1383450-81-4
    D.3.9.2Current sponsor codeJNJ-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.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 respiratorio sincitial
    E.1.1.1Medical condition in easily understood language
    Respiratory Syncytial Virus
    Virus respiratorio sincitial
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    The main objective of the study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 mg and 500 mg) once daily for 7 days in adults with respiratory syncytial virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.
    El objetivo principal del estudio es explorar el efecto antiviral de dos dosis de JNJ-53718678 (80 mg y 500 mg) administrado una vez al día durante 7 días en adultos con infección por el VRS, mediante la determinación de la carga viral del VRS en secreciones nasales mediante un ensayo de reacción en cadena de la polimerasa por transcripción inversa cuantitativa (qRT-PCR).
    E.2.2Secondary objectives of the trial
    - To explore in adults with RSV infection, after repeated oral dosing with JNJ-53718678:
    a) The safety and tolerability of JNJ-53718678;
    b) The impact of JNJ-53718678 on the clinical course of RSV infection;
    c) The pharmacokinetics of JNJ-53718678.
    Analizar en adultos con infección por el VRS después de que estos hayan recibido dosis repetidas por vía oral de JNJ-53718678:
    • La seguridad y tolerabilidad de JNJ-53718678
    • El efecto de JNJ-53718678 en la evolución clínica de la infección por el VRS
    • La farmacocinética del JNJ-53718678
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female.
    2. ≥18 years of age.
    3. Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and is willing to participate in the study.
    Note: Prior to signing the main consent form for the study, subjects may specifically allow for the collection and testing of nasal mid-turbinate swabs by signing the pre screening (diagnostic) ICF.
    4. Subjects must have an acute respiratory illness with signs and symptoms consistent with a viral infection (example, 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. Onset of symptoms is defined as the time the subject becomes aware of the first sign and/or symptom consistent with a viral infection. Efforts should be made to determine the time of onset of symptoms as accurately as possible (in relation to routine daily activities).
    Note: The viral infection may present in any way as long as the underlying precipitant of the illness is considered by the investigator to be due to RSV infection. Examples of such an illness include:
    - An upper or lower viral respiratory tract infection (eg, “flu-like illness”);
    - Pneumonia;
    - Respiratory distress;
    - Asthma exacerbation;
    - COPD exacerbation.
    5. Subject has been diagnosed with RSV infection using a rapid polymerase chain reaction (PCR) based (preferably locally available) or rapid-antigen-detection test.
    Note: If a patient has a positive similar diagnostic test from another study and meets all eligibility criteria for inclusion in this study, this diagnostic test result can be used for confirmation of eligibility.

    Please refer to the protocol for other inclusion criteria
    1. Hombre o mujer,
    2. ≥18 años de edad.
    3. Deben firmar un consentimiento informado indicando que entienden el propósito de y los procedimientos requeridos para el estudio y que están dispuestos a participar en el estudio.
    4. Con una enfermedad respiratoria aguda con signos y síntomas consistentes con una infección viral (p. ej., fiebre, tos, congestión nasal, secreción nasal, irritación de garganta, mialgia, letargo, dificultad respiratoria o sibilancias) con un inicio ≤ a 5 días con respecto al momento previsto de aleatorización. El inicio de los síntomas se define cómo el momento en que el paciente percibe el primer signo y/o síntoma que sea compatible con una infección vírica. Se deberá tratar de determinar el momento de aparición de los síntomas con la mayor precisión posible (en relación con las actividades diarias de rutina). La infección vírica puede presentarse de cualquier forma siempre y cuando el investigador considere que el factor precipitante subyacente de la enfermedad tiene su origen en una infección por el VRS. Ejemplos de tal enfermedad incluyen: infección vírica de las vías respiratorias superiores o inferiores, (ejemplo gripe), neumonía, dificultad respiratoria, agravamiento del asma, agravamiento de la EPOC.
    5. Diagnóstico de infección por el VRS mediante una prueba de PCR rápida (preferiblemente que esté disponible en el laboratorio local) o una prueba rápida de detección de antígenos. (Si un paciente tiene un resultado positivo en una prueba diagnóstica similar de otro estudio y cumple todos los criterios de elegibilidad para la inclusión en este estudio, se podrá utilizar el resultado de esa prueba para confirmar la elegibilidad.)

    Por favor refiérase al protocolo para otros criterios de inclusión.
    E.4Principal exclusion criteria
    Any potential subject who meets any of the following criteria will be excluded from participating in the study:
    1. Hospitalized subjects or subjects expected to be hospitalized within 24 hours of screening.
    Note: Any stay in the emergency room or in the observational unit of at least 24 hours will be considered hospitalization for the purposes of the study.
    2. History of or concurrent illness (beyond a comorbid condition) 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.
    3. Subjects who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study.
    4. Subjects who are 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 human immunodeficiency virus [HIV] infection) or medical therapy (eg, medications other than corticosteroids for the treatment of chronic obstructive pulmonary disease (COPD) or asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant).
    5. Subject has known or suspected chronic or acute hepatitis B or C infection.

    Please refer to the protocol for other exclusion criteria
    Se excluirá de la participación en este esudio a cualquier potencial paciente que cumpla cualquiera de los siguientes criterios:
    1. Hospitalizados o que se espere que sean hospitalizados en las 24 horas siguientes a la selección. A efectos de este estudio, toda estancia en el servicio de urgencias o en la unidad de observación de al menos 24 horas se considerará hospitalización.
    2. Antecedentes de enfermedades simultáneas (excepto comorbilidades) que en opinión del investigador puedan confundir el resultado del estudio o suponer un riesgo adicional en la administración del fármaco del estudio al paciente o que puedan prevenir, limitar o confundir las evaluaciones específicas del protocolo.
    3. Pacientes que hayan tenido una cirugía importante en los 28 días previos a la aleatorización o que tengan una cirugía importante programada durante el transcurso del estudio.
    4. Inmunodeprimidos, en opinión del investigador, en los últimos 12 meses, ya sea por una enfermedad médica subyacente (p. ej., tumor o trastorno genético diferente de la deficiencia de inmunoglobulina A, o infección por el virus de la inmunodeficiencia humana [VIH]) o por tratamiento médico (p. ej., medicamentos distintos de los corticoesteroides para tratar los agravamientos de la EPOC o el asma, quimioterapia, radiación, trasplante de células madre o de órganos sólidos).
    5. Diagnóstico confirmado o sospecha de infección por hepatitis B o C crónica o aguda.
    E.5 End points
    E.5.1Primary end point(s)
    1. Area Under the Respiratory Syncytial Virus (RSV) Viral Load-time Curve (AUC)
    2. RSV Viral Load and Change From Baseline Over Time
    3. Time to Undetectable RSV Viral Load
    4. Proportion of Subjects With Undetectable RSV Viral Load at Each Time Point
    1. El área bajo la curva (ABC) de la carga viral del VRS
    2. La carga viral del VRS y el cambio a lo largo del tiempo con respecto a la visita basal
    3. El tiempo hasta que la carga viral del VRS se vuelve indetectable
    4. La proporción de pacientes con carga viral de VRS indetectable en cada momento del estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline through Day 3, Day 8, and Day 14
    2, 3, & 4. Throughout the study (Approximately 29 days)
    1. Visita basal hasta el día 3, el día 8 y el día 14
    2, 3 y 4. A lo largo del estudio (aproximadamente 29 días)
    E.5.2Secondary end point(s)
    1. Safety and Tolerability, as Assessed by Adverse Events (AEs), Clinical Laboratory Testing, ECGs, Vital Signs, Physical Examination
    2. Duration and Severity of Signs and Symptoms of RSV Infection Assessed Through an Instrument for Patient-Reported Symptoms (the Respiratory Infection-Patient Reported Outcomes [RI PRO] Questionnaire) and Additional Questions About Health and Functioning
    3. Time to Alleviation of Selected RSV Symptoms as Reported by the Subject
    4. Respiratory Rate
    5. Heart Rate
    6. Body Temperature
    7. Peripheral Capillary Oxygen Saturation (SpO2)
    8. Predose Plasma Concentration (Ctrough) JNJ-53718678
    9. Maximum Observed Concentration (Cmax) of JNJ-53718678
    1.La seguridad y la tolerabilidad, evaluadas mediante los acontecimientos adversos (AA), los análisis de laboratorio clínicos, los electrocardiogramas (ECG), las constantes vitales y la exploración física;
    2.La duración y la gravedad de los signos y síntomas de la infección por el VRS valorados mediante un cuestionario para los síntomas referidos por el paciente (el cuestionario de resultados referidos por el paciente con infección respiratoria [RCP-IR]) y preguntas complementarias acerca de la salud y el funcionamiento;
    3.El tiempo transcurrido hasta la reducción de los síntomas del VRS referidos por el paciente;
    4.La frecuencia respiratoria
    5.Ritmo cardíaco
    6.La temperatura corporal
    7.La saturación de oxígeno capilar periférica (SpO2)
    8. Concentración plasmática predosis de JNJ-53718678
    9. Concentración máxima observada (Cmax) de JNJ-53718678
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At baseline, Day 3, 8, 14, 21 and 28.
    2. Till Day 21
    3. Day 1 to 14 and Day 21
    4 to 7. At baseline, Day 2 to 8, Day 14, 21 and 28.
    8 & 9. Day 3 and Day 8
    Exploratory End points:
    1 to 9. At baseline and throughout the study (Approximately 29 days)
    1. Visita basal, Día 3, 8, 14, 21 y 28.
    2. Hasta el día 21
    3. Día 1 a 14 y día 21
    4 a 7. Visita basal, Día 2 a 8, Día 14, 21 y 28.
    8 y 9. Día 3 y día 8
    Criterios de valoración exploratorios:
    1 a 9. Visita basal y durante todo el estudio (Aproximadamente 29 días)
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    France
    Germany
    Korea, Democratic People's Republic of
    Malaysia
    Mexico
    Poland
    Russian Federation
    South Africa
    Spain
    Sweden
    Taiwan
    Ukraine
    United States
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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 months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 75
    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)
    Standard care of treatment
    Tratamiento médico estandar
    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 Decision2018-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    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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