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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2010-019562-91
    Sponsor's Protocol Code Number:GS-EU-131-0247
    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:2010-11-26
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-019562-91
    A.3Full title of the trial
    Estudio de fase 3, doble ciego, multicéntrico, aleatorizado, controlado con placebo, para evaluar la eficacia, seguridad y tolerabilidad del tratamiento profiláctico con anfotericina B liposomal (AmBisome®) para la prevención de infecciones fúngicas invasivas (IFI) en sujetos que reciben quimioterapia de inducción a la remisión para la leucemia linfoblástica aguda (LLA)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberGS-EU-131-0247
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGilead Sciences International Ltd
    B.1.3.4CountryUnited Kingdom
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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. name AMBISOME polvo para solución para infusión intravenosa
    D. of the Marketing Authorisation holderGILEAD SCIENCES, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1397-89-3
    D.3.9.3Other descriptive nameAMPHOTERICIN B
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Invasive fungal infections (IFI) in subjects with Acute Lymphoblastic Leukemia (ALL) undergoing remission induction chemotherapy. Infecciones fúngicas invasivas (IFI) en pacientes con Leucemia Linfoblástica Aguda (LLA) que reciben quimioterapia de inducción a la remisión.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10017533
    E.1.2Term Fungal infection
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ? Determinar la eficacia profiláctica de AmBisome en comparación con un placebo para la prevención de IFI en sujetos con LLA que reciben quimioterapia de inducción a la remisión.
    E.2.2Secondary objectives of the trial
    ? Determinar la seguridad y tolerabilidad del tratamiento profiláctico con AmBisome en sujetos con LLA que reciben quimioterapia de inducción a la remisión.
    ? Determinar el impacto de la prevención de IFI en la eficacia de la quimioterapia de inducción a la remisión en sujetos con LLA.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Los sujetos aleatorizados de un subconjunto de sitios recibirán la opción de prestar su consentimiento para un subestudio de FC en el que participarán 40 sujetos para determinar los niveles mínimos de AmBisome durante la administración de dos dosis por semana. La monitorización FC consistirá en la extracción de una muestra de sangre adicional para evaluar los niveles de AmBisome inmediatamente antes de cada perfusión del fármaco del estudio durante cuatro semanas (8 perfusiones del fármaco del estudio), y la primera muestra se extraerá inmediatamente antes de la segunda perfusión. Con el programa de aleatorización 2:1, se prevé que se conseguirán los niveles mínimos de concentración de AmBisome obtenidos con la administración de dos dosis por semana de aproximadamente 26 sujetos.
    E.3Principal inclusion criteria
    Los sujetos deben cumplir con todos los siguientes criterios de inclusión para ser elegibles para la participación en este estudio.
    ? LLA diagnosticada recientemente, con administración de un régimen de quimioterapia para la LLA que induce habitualmente a un mínimo de 10 días de neutropenia.
    ? Edad ? 18 años.
    ? Posibilidad de realizarse rápidamente todas las pruebas de selección para asegurar que los resultados se puedan obtener y evaluar antes de la aleatorización, de manera tal que la primera dosis del fármaco del estudio aleatorizado para la profilaxis de IFI pueda administrarse en el plazo de 5 días desde el inicio de la primera quimioterapia de inducción a la remisión.
    ? Capacidad para comprender y firmar un formulario de consentimiento informado por escrito, que debe obtenerse antes del inicio de cualquier procedimiento del estudio.
    E.4Principal exclusion criteria
    En este estudio, no se inscribirán sujetos que cumplan con cualquiera de los siguientes criterios de exclusión.
    ? Hipersensibilidad conocida a la anfotericina B o AmBisome, los metabolitos o los excipientes de la formulación; en particular, antecedentes conocidos de reacción anafiláctica a la anfotericina B o AmBisome, o a cualquiera de sus metabolitos o excipientes de la formulación.
    ? Hipersensibilidad conocida a los excipientes de la formulación del placebo.
    ? Fiebre en la actualidad (? 38 °C), salvo que se explique por causas no infecciosas.
    ? Sujetos con IFI comprobada, probable o posible (de acuerdo con los criterios de EORTC/MSG) en la selección o en la historia clínica del sujeto.
    ? Infiltrados pulmonares.
    ? Tratamiento concomitante o previo con un fármaco antifúngico dentro de los 30 días anteriores, a menos que el nivel plasmático sea inferior al límite de detección o que hayan transcurrido al menos 5 semividas del antifúngico desde la administración del tratamiento.
    ? Creatinina sérica > 2 x el límite superior de la normalidad (LSN).
    ? Resultados de Grado 3 en las pruebas de función hepática: alanina aminotransferasa o aspartato aminotransferasa > 5 x LSN; bilirrubina total > 2,5 x LSN.
    ? Cualquier comorbilidad grave que no sea la enfermedad hematológica subyacente (LLA) que a criterio del investigador podría interferir en las evaluaciones del estudio o afectar la seguridad del sujeto.
    ? Sujetos que han recibido algún fármaco en investigación en los últimos 30 días antes de la selección, con excepción de productos en investigación empleados en la quimioterapia para la LLA como parte del protocolo de tratamiento actual para la LLA del sujeto.
    ? Mujeres embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo principal de este estudio es evaluar la eficacia de la profilaxis antifúngica de 5 mg/kg de AmBisome en comparación con placebo. El criterio de valoración primario de eficacia que respalda este objetivo es la proporción de sujetos con IFI comprobadas o probables durante la quimioterapia de inducción a la remisión para la LLA.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.3 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    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
    Last patient, last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 258
    F.4.2.2In the whole clinical trial 354
    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)
    Eligible subjects will be able to start consolidation therapy. If a subject is still neutropenic, the site should continue to monitor and treat the subject according to their normal clinical practice.
    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 Decision2011-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-29
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