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    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-001384-68
    Sponsor's Protocol Code Number:TMC114FD2HTX1006
    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:2019-07-26
    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 number2019-001384-68
    A.3Full title of the trial
    A Study to Assess the Acceptability of Scored Film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Tablets in HIV-1 Infected Pediatric Participants (Aged ≥6 to <12 years), Using Matching Placebo Tablets
    Ensayo para evaluar la aceptabilidad de comprimidos ranurados recubiertos con película de darunavir/cobicistat/emtricitabina/tenofovir alafenamida (D/C/F/TAF) a dosis fija en participantes pediátricos infectados con VIH-1 de edad ≥6 a <12 años, usando comprimidos equivalentes de placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Acceptability of Scored Film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Tablets in HIV-1 Infected Pediatric Participants (Aged ≥6 to <12 years), Using Matching Placebo Tablets
    Ensayo para evaluar la aceptabilidad de comprimidos ranurados recubiertos con película de darunavir/cobicistat/emtricitabina/tenofovir alafenamida (D/C/F/TAF) a dosis fija en participantes pediátricos infectados con VIH-1 de edad ≥6 a <12 años, usando comprimidos equivalentes de placebo
    A.4.1Sponsor's protocol code numberTMC114FD2HTX1006
    A.7Trial is part of a Paediatric Investigation Plan Yes
    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 Unlimited Company
    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 Spain
    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 number003491 7228075
    B.5.5Fax number003491 7228628
    B.5.6E-mailerodrig4@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 Yes
    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 nameDarunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide (D/C/F/TAF) FDC tablet (Placebo)
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.3.11.13.1Other medicinal product type1 placebo tablet identical in size, shape, and appearance to the pediatric scored film coated 675/150/200/10 mg D/C/F/TAF FDC tablets
    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 placeboFilm-coated tablet
    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
    Human Immunodeficiency Virus Type 1
    Virus de la Inmunodeficiencia Humana Tipo 1
    E.1.1.1Medical condition in easily understood language
    HIV-1
    VIH-1
    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 10068341
    E.1.2Term HIV-1 infection
    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 primary objective is to assess the ability to swallow the scored film-coated D/C/F/TAF FDC tablet, irrespective of the mode of intake.
    El objetivo principal es evaluar la capacidad de tragar el comprimido ranurado recubierto con película con una CDF de D/C/F/TAF independientemente del modo de ingestión.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To assess the acceptability of swallowing the scored film coated D/C/F/TAF FDC tablet, taken as a whole tablet and as a split tablet
    • To assess the acceptability of the intake of the scored film-coated D/C/F/TAF FDC tablet, if to be taken daily as a whole tablet and as a
    split tablet.
    • To assess the ease of splitting the scored film-coated D/C/F/TAF FDC tablet.
    Los objetivos secundarios son:
    • Evaluar la aceptabilidad de tragar el comprimido ranurado recubierto con película con una CDF de D/C/F/TAF cuando se toma entero y cuando se toma partido en dos.
    • Evaluar la aceptabilidad de tomar el comprimido ranurado recubierto con película con una CDF de D/C/F/TAF si se va a tomar diariamente entero y partido en dos.
    • Evaluar la facilidad con la que se puede partir el comprimido ranurado recubierto con película con una CDF de D/C/F/TAF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential participant must satisfy all of the following criteria to be enrolled in the study:
    1. Male or female.
    2. ≥6 to <12 years of age.
    3. Have a body weight of at least 25 kg and less than 40 kg.
    4. Has documented chronic HIV-1 infection.
    5. Must be on a stable ARV regimen for at least 3 months prior to screening.
    6. Has documented plasma HIV-1 ribonucleic acid (RNA) <400 copies/mL within 6 months prior to screening.
    7. Parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older).
    8. Must be able to comply with the protocol requirements (willing to attempt swallowing tablets; and adhere to prohibitions and restrictions specified in this protocol).
    Cada participante potencial debe satisfacer todos los siguientes criterios para ser incluido en el estudio:
    1. Hombre o mujer.
    2. ≥6 a <12 años de edad.
    3. Tener un peso corporal de al menos 25 kg y menos de 40 kg.
    4. Tener documentada una infección crónica por VIH-1.
    5. Debe estar en un régimen estable de ARV por lo menos 3 meses antes de la selección.
    6. Tener documentado plasma VIH-1 ácido ribonucleico (ARN) <400 copias/mL dentro de los 6 meses previos a la prueba.
    7. Los padres (preferiblemente si están disponibles o según los requisitos locales) o su representante legalmente aceptable deben firmar un ICF indicando que entienden el propósito y los procedimientos requeridos para el estudio y que están dispuestos a permitir que el niño participe en el estudio. También se requiere el asentimiento de los niños capaces de entender la naturaleza del estudio (típicamente de 7 años de edad o más).
    8. Debe ser capaz de cumplir con los requisitos del protocolo (capaz de intentar tragar comprimidos; y adherirse a las prohibiciones y restricciones especificadas en este protocolo).
    E.4Principal exclusion criteria
    Any potential participant who meets any of the following criteria will be excluded from participating in the study:
    1. Any active condition (eg, active oral infection [candidiasis], significant physical or psychological disease or other findings during screening) that could prevent the participant from swallowing, or limit or confound the protocol specified assessments and outcomes or for which, in the opinion of the investigator, participation could compromise the safety or well-being of the participant.
    2. Taking any disallowed therapies, Concomitant Therapy.
    3. Is a family member of an employee or investigator of the study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee of Johnson & Johnson.
    4. Have any known allergies to the excipients of the placebo tablet
    Cualquier participante potencial que cumpla con cualquiera de los siguientes criterios será excluido de participar en el estudio:
    1. Cualquier condición activa (p. ej., infección oral activa[candidiasis], enfermedad física o psicológica significativa u otros hallazgos durante el periodo de selección) que pudiera impedir que el participante trague, o limitar o confundir las evaluaciones y resultados especificados en el protocolo o para los cuales, en opinión del investigador, la participación pudiera comprometer la seguridad o el bienestar del participante.
    2. Tomar cualquier terapia no permitida, Terapia concomitante.
    3. Ser un miembro de la familia de un empleado o investigador del centro de estudio con participación directa en el estudio propuesto u otros estudios bajo la dirección de ese investigador o centro de estudio, o es un miembro de la familia de un empleado de Johnson & Johnson.
    4. tener alguna alergia conocida a cualquiera de los excipientes del comprimido de placebo.
    E.5 End points
    E.5.1Primary end point(s)
    1. The ability to swallow the tablet, irrespective of the mode of intake.
    1. La capacidad de tragar la tableta, independientemente del modo de ingesta.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Day 1
    1. Día 1
    E.5.2Secondary end point(s)
    1. A 3-point questionnaire to assess the acceptability of the intake of the
    whole tablet and as a split tablet by the participant and by the caregiver.
    2. A 3-point questionnaire to assess the acceptability of the intake of the
    whole tablet and as a split tablet by the participant, if to be taken daily.
    3. A 3-point questionnaire to assess the ease of splitting the tablet by
    the participant's caregiver.
    4. A questionnaire to assess the swallowing difficulties as reported by
    the observer.
    5. Assessment of adverse events (AEs).
    1. Un cuestionario de 3 puntos para evaluar la aceptabilidad del participante y del cuidador a la hora de ingerir el comprimido entero y partido en dos.
    2. Un cuestionario de 3 puntos para evaluar la aceptabilidad del participante a la hora de ingerir el comprimido entero y partido en dos, si se va a tomar diariamente.
    3. Un cuestionario de 3 puntos para evaluar la facilidad con la que el cuidador del participante puede partir el comprimido.
    4. Un cuestionario para evaluar las dificultades de deglución comunicadas por el observador.
    5. Evaluación de los acontecimientos adversos (AA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 6: Within 15 minutes after each observed intake and before next intake
    7: Throughout the study
    1 a 6: Dentro de los 15 minutos siguientes a cada ingesta observada y antes de la siguiente ingesta
    7: A lo largo del estudio
    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 No
    E.6.7Pharmacodynamic No
    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
    Acceptability, swallowability and Tolerability
    Aceptabilidad, deglutibilidad y tolerabilidad
    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
    Assessment of acceptability/swallowability
    Evaluación de la aceptabilidad y la deglutibilidad
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 concerned4
    E.8.5The trial involves multiple Member States No
    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
    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
    Última 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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial days22
    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: 24
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    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 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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 24
    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
    Ninguno
    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 Decision2019-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-06
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