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    Summary
    EudraCT Number:2011-000499-32
    Sponsor's Protocol Code Number:FSJD-ABELNEB-2010
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-06-30
    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 number2011-000499-32
    A.3Full title of the trial
    A PHASE II CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF AMPHOTERICIN B LIPID COMPLEX (ABELCET®) FOR THE PROPHYLAXIS OF INVASIVE PULMONARY ASPERGILLOSIS DURING PROLONGED NEUTROPENIA IN PAEDIATRIC PATIENTS WITH ACUTE LEUKAEMIA
    ENSAYO CLÍNICO DE FASE II PARA EVALUAR LA SEGURIDAD Y LA TOLERABILIDAD DE AMFOTERICINA B COMPLEJO LIPÍDICO (ABELCET®) NEBULIZADO PARA LA PROFILAXIS DE LA ASPERGILOSIS PULMONAR INVASIVA DURANTE LA NEUTROPENIA PROLONGADA EN LOS PACIENTES PEDIÁTRICOS CON LEUCEMIA AGUDA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PHASE II CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF AMPHOTERICIN B LIPID COMPLEX (ABELCET®) FOR THE PROPHYLAXIS OF INVASIVE PULMONARY ASPERGILLOSIS DURING PROLONGED NEUTROPENIA IN PAEDIATRIC PATIENTS WITH ACUTE LEUKAEMIA
    ENSAYO CLÍNICO DE FASE II PARA EVALUAR LA SEGURIDAD Y LA TOLERABILIDAD DE AMFOTERICINA B COMPLEJO LIPÍDICO (ABELCET®) NEBULIZADO PARA LA PROFILAXIS DE LA ASPERGILOSIS PULMONAR INVASIVA DURANTE LA NEUTROPENIA PROLONGADA EN LOS PACIENTES PEDIÁTRICOS CON LEUCEMIA AGUDA
    A.4.1Sponsor's protocol code numberFSJD-ABELNEB-2010
    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 SponsorFUNDACIÓ SANT JOAN DE DEU
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinisterio de Sanidad y Política Social.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACIÓ SANT JOAN DE DEU
    B.5.2Functional name of contact pointFUNDACIÓ SANT JOAN DE DEU
    B.5.3 Address:
    B.5.3.1Street AddressC/ Santa Rosa 39-57
    B.5.3.2Town/ cityEsplugues de Llobregat-Barcelona
    B.5.3.3Post code08950
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493600 97 51
    B.5.5Fax number+3493600 97 71
    B.5.6E-mailrmorales@fsjd.org
    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.2.1.1.1Trade name ABELCET 5 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderCephalon Pharma, S.L.U.
    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 Suspension for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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.3.9.4EV Substance CodeSUB05486MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Invasive pulmonary aspergillosis in patients with acute myeloblastic or lymphoblastic leukaemia.
    Aspergilosis pulmonar invasiva en pacientes con leucemia aguda, mieloblástica o linfoblástica.
    E.1.1.1Medical condition in easily understood language
    Invasive pulmonary infection due to aspergillus fungus in patients with acute myeloblastic or lymphoblastic leukaemia.
    Infección pulmonar invasiva por hongo Aspergillus en pacientes con leucemia aguda, mieloblástica o linfoblástica.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10022881
    E.1.2Term Invasive bronchopulmonary aspergillosis
    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 evaluate the overall tolerability of the drug, defined as any adverse event that results in the interruption of treatment, during primary prophylaxis with nebulized ABLC, in paediatric patients with acute leukaemia (AL) undergoing intensive chemotherapy.
    Evaluar la tolerabilidad global del fármaco, definida como cualquier acontecimiento adverso que suponga la interrupción del tratamiento, durante la profilaxis primaria con ABCL nebulizado, en pacientes pediátricos con leucemia aguda (LA) tratados con quimioterapia intensiva.
    E.2.2Secondary objectives of the trial
    1.To evalute the efficacy of primary prophylaxis with nebulized ABLC on the incidence of invasive pulmonary aspergillosis (IPA) in paediatric patients with LA undergoing intensive chemotherapy.
    2.To determine the IPA-related mortality during primary prophylaxis with ABLC in paediatric patients with (AL) undergoing intensive chemotherapy.
    1.Evaluar la eficacia de la profilaxis primaria con ABCL nebulizado sobre la incidencia de aspergilosis pulmonar invasiva (API) en pacientes pediátricos con LA tratados con quimioterapia intensiva.
    2.Evaluar la mortalidad relacionada a la API durante la profilaxis primaria con ABCL nebulizado en pacientes pediátricos con LA tratados con quimioterapia intensiva.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: patients between 3 and 18 years.
    2. Diagnosis of myeloblastic or lymphoblstic AL during intensive chemotherapy.
    3. Informed consent of parents/guardians and/or assent of the patient has been obtained.
    1.Edad: pacientes menores de entre 3 y 18 años.
    2.Diagnóstico de LA mieloblástica o linfoblástica en fase de tratamiento con quimioterapia intensiva.
    3.Obtención del consentimiento informado de padres/tutores y/o asentimiento del paciente.
    E.4Principal exclusion criteria
    1.Probable or proven invasive pulmonary fungal infection before entering the trial.
    2.Previous chronic renal impairment or baseline serum creatinine > 2.5 mg /dL
    3.Severe hepatic impairment.
    4.Moderate-severe asthma being treated pharmacologically.
    5.Antifungal treatment for filamentous fungi in the last 4 weeks.
    6.Participating or have participated in a clinical trial during the last 4 weeks.
    7.Mentally retarded
    8.Known allergy or hypersensitivity to the active ingredient of the study drug or to any of its excipients.
    9.Any serious concomitant disease that in the investigator?s opinion could compromise the completion of the trial or affect the patient?s tolerability to this treatment.
    10.Pregnancy (in women of fertile age).
    11.Breast-feeding.

    Patients are defined as having probable IFI when their radiological image is suggestive of fungal infection and they have positive antigenemia for Aspergillus. IFI would be proven when the presence of Aspergillus is confirmed in aspirate culture or by lung biopsy.
    1.Infección fúngica invasiva pulmonar (IFI) probable o probada antes de entrar en el ensayo.
    2.Insuficiencia renal crónica previa o creatinina sérica basal > 2,5 mg /dl
    3.Insuficiencia hepática grave.
    4.Asma moderado-grave en tratamiento farmacológico.
    5.Tratamiento con antifúngicos contra hongos filamentosos en las últimas 4 semanas.
    6.Participar o haber participado en un ensayo clínico durante las últimas 4 semanas.
    7.Retraso mental.
    8.Alergia o hipersensibilidad conocida al principio activo del fármaco en investigación, o a cualquiera de sus excipientes.
    9.Cualquier enfermedad concomitante grave que en la opinión del investigador pueda comprometer completar el estudio o afectar la tolerancia del paciente para este tratamiento.
    10.Embarazo (en las mujeres en edad fértil).
    11.Lactancia.

    Se define como IFI probable aquella en los que el paciente presenta una imagen radiológica sugestiva de infección fúngica y antigenemia positiva por Aspergillus. La IFI quedaría probada cuando se confirmara la presencia de Aspegillus en cultivo de aspirado o por biopsia pulmonar
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the proportion of patients who discontinue prophylactic treatment with ABLC due to an adverse event that is related or not to the study drug or for intolerability to it.
    La variable primaria de eficacia será la proporción de pacientes que discontinúan el tratamiento profiláctico con ABCL por un acontecimiento adverso relacionado o no con el fármaco en estudio o por intolerancia al mismo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    They will be analysed by homogeneity tests comparing the results with those of a historical cohort. The hypothesis tests and confidence intervals will be calculated by exact methods given the low sample size.
    Se analizarán mediante pruebas de homogeneidad comparando los resultados observados respecto a la cohorte histórica. Las pruebas de hipótesis e intervalos de confianza se calcularán por métodos exactos dado el bajo tamaño de la muestra.
    E.5.2Secondary end point(s)
    The secondary variables to be obtained are the following:

    -Proportion of discontinued drug administrations due to a treatment-related adverse event or intolerability to treatment (number of discontinued administrations/ number of administrations started)
    -Total number of IPA cases
    -Incidence of IPA during the ABLC (Abelcet®) prophylactic treatment period (number of patients with IPA/number of patients on prophylaxis).
    -IPA incidence rate during the ABLC prophylactic treatment period (number of patients with aspergillosis/time on prophylaxis of study patients).
    -Mortality due to IPA
    -Percentage of deaths during the prophylactic treatment period and cause of death.
    Se recogerán las siguientes variables secundarias:
    -Proporción de administraciones del fármaco que discontinúan por un acontecimiento adverso relacionado con el tratamiento o intolerancia al mismo (nº administraciones interrumpidas/nº administraciones iniciadas )
    -Número total de casos de API
    -Incidencia de API durante el período de tratamiento profiláctico con ABLC (Abelcet®) (nº de pacientes con API/nº de pacientes en profilaxis).
    -Tasa de incidencia de API durante el período de tratamiento profiláctico con ABCL (nº pacientes con aspergilosis/tiempo en profilaxis de los pacientes en estudio)
    -Mortalidad por API
    -Porcentaje de fallecidos durante el tratamiento profiláctico y causa de fallecimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the analysis of patients who died due to IPA or other causes a Kaplan-Meier survival analysis will be performed. The median survival time and the % of cumulative survival will be estimated with their respective 95% confidence intervals.
    The 95% confidence interval (95% CI) will be calculated for the presence/absence of toxicity and toxicity severity (CTCAE grades 1 to 4) variable. All the adverse events will be listed giving their severity and relation to the study drug. The categorical variables will be will be summarised by frequency distributions whilst the central tendency and dispersion will be given for the quantitative variables and, if appropriate, their 95% confidence intervals (95% CI).
    Para el análisis de pacientes fallecidos por API u otras causas se realizará un análisis de supervivencia mediante el método de Kaplan-Meier. Se estimarán la mediana del tiempo de supervivencia y el % de supervivencia acumulada, con sus intervalos de confianza respectivos al 95%.
    En la variable presencia/ausencia de toxicidad y gravedad de toxicidad (grados CTCAE 1 a 4) se calculará su intervalo de confianza (IC95%). Se listarán todos los acontecimientos adversos considerando su gravedad y su relación con el fármaco en estudio. Las variables categóricas se resumirán mediante distribuciones de frecuencias mientras que, para las variables cuantitativas, se informará de tendencia central y dispersión y, si es apropiado, se presentará su intervalo de confianza al 95% (IC95%).
    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 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 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 No
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No aplica
    Not applicable
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last patient last visit will be the end of the trial
    El final del ensayo coincide con la última visita del último sujeto
    reclutado en el ensayo
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 30
    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: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-06-30. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants less than 11 years old.
    Niños menores de 11 años de edad.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    Not applicable
    No aplica
    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 Decision2011-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-29
    P. End of Trial
    P.End of Trial StatusOngoing
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