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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2011-000804-17
    Sponsor's Protocol Code Number:GESITRA0110
    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:2011-09-15
    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 number2011-000804-17
    A.3Full title of the trial
    Randomized, multicentric, open label comparative trial to assess safety of Anidulafungina versus Anfotericina B Liposomal for antifungic profilaxis in high risk hepatic transplanted patients. AVALTRA Study.
    "Ensayo clínico aleatorizado, multicéntrico y abierto para comparar la seguridad de Anidulafungina frente a Anfotericina B Liposomal en la profilaxis antifúngica en pacientes con trasplante hepático de alto riesgo". Estudio AVALTRA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial comparing the safety of two antifungic profilaxis: Anidulafungina versus Anfotericina B Liposomal in patients receiving an hepatic transplant.
    Ensayo clínico para comparar la seguridad de dos tratamientos: Anidulafungina frente a Anfotericina B liposomal en la profilaxis por hongos en pacientes que reciben un trasplante de hígado de alto riesgo.
    A.3.2Name or abbreviated title of the trial where available
    AVALTRA
    A.4.1Sponsor's protocol code numberGESITRA0110
    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 SponsorFUNDACION SEIMC-GESIDA
    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 supportPfizer, S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACION SEIMC-GESIDA
    B.5.2Functional name of contact pointManolo Cotarelo
    B.5.3 Address:
    B.5.3.1Street AddressC/ General Moscardó 2, 1º izdq.
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28020
    B.5.3.4CountrySpain
    B.5.4Telephone number34915568025
    B.5.5Fax number34915542283
    B.5.6E-mailmcotarelo@f-sg.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 AMBISOME polvo para solución para infusión intravenosa
    D.2.1.1.2Name 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 Lyophilisate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMFOTERICINA B
    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/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 typeAntibiótico (antimicótico)
    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 Yes
    D.2.1.1.1Trade name ECALTA 100 mg polvo para concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER LIMITED
    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.3.1Product nameECALTA
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANIDULAFUNGINA
    D.3.9.3Other descriptive nameANIDULAFUNGINA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200
    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 typeAntibiótico (antimicótico)
    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
    Hepatic transplanted patient with high risk of invasory fungic infection.
    Pacientes trasplantados hepáticos con alto riesgo de infección fúngica invasora.
    E.1.1.1Medical condition in easily understood language
    Patients who has received hepatic transplant and with high risk of fungi infection
    Pacientes que han recibido trasplante de hígado y tienen alto riesgo de desarrollar infección fúngica.
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10049991
    E.1.2Term Candidal infection NOS
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10003486
    E.1.2Term Aspergillus infections
    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
    Comparar la aparición de insuficiencia renal, probada o probable, o deterioro de la función renal basal y/o el desarrollo de efectos adversos relacionados con la infusión en pacientes con trasplante hepático de alto riesgo que reciban Anfotericina B liposomal o Anidulafungina.
    E.2.2Secondary objectives of the trial
    1. Comparar la proporción de pacientes que deben discontinuar la profilaxis por efectos adversos entre las dos ramas.
    2. Comparar la aparición de toxicidad hepática entre las 2 ramas de tratamiento a las dos semanas de finalización del tratamiento.
    3. Comparar la incidencia de infección fúngica invasora, precoz (primeras 12 semanas) y tardía (hasta la semana 24) entre las dos ramas de tratamiento.
    4. Comparar la mortalidad global y relacionada con infección fúngica entre las 2 ramas de tratamiento a la semana 24 post-trasplante.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes con consentimiento informado del estudio por escrito antes de realizar cualquier procedimiento de selección específico para el estudio.

    2. Pacientes adultos (18 años de edad).

    3. Pacientes receptores de transplante de injerto hepático ortotópico completo o de un segmento del hígado.

    4. Pacientes que cumplan uno de los siguientes criterios, documentados en la historia clínica del paciente:

    A. Criterios mayores: presentar uno de los siguientes:
    a. Retrasplante por disfunción severa de un injerto hepático ortotópico previo.
    b. Insuficiencia renal post-trasplante (definida como aclaramiento de creatinina < 50 mL/min) en visita basal del estudio).
    c. Requerimiento de cualquier terapia sustitutiva renal, incluyendo diálisis o hemofiltración.
    d. Hepatitis fulminante que requiera trasplante hepático.
    o
    B. Criterios menores: presentar dos de los siguientes:
    a. Transfusión intraoperatoria de 40 uds de derivados sanguíneos celulares.
    b. Reconstrucción biliar mediante coledocoyeyunostomía.
    c. 2 cultivos positivos para Candida spp. (nasal, faríngeo o rectal) desde 48 horas antes a 48 horas después del trasplante hepático.
    d. Reintervención post-trasplante (laparotomía) en los 30 días post-transplante.
    5. Si pacientes de sexo femenino con capacidad potencial de embarazo, test negativo de embarazo en sangre o en orina antes de la inclusión en el estudio y compromiso de utilizar durante todo el estudio un método anticonceptivo de barrera de fiabilidad demostrada a juicio del investigador.
    E.4Principal exclusion criteria
    1. Hipersensibilidad conocida a Anfotericina B o a Candinas.
    2. Pacientes que hayan recibido cualquier medicación antifúngica (excluyendo fluconazol o nistatina oral durante un máximo de 7 días) en los 30 días previos a la inclusión en el estudio.
    3. Pacientes que sufran una infección fúngica documentada (probada o probable) o sospecha de infección fúngica (posible).
    4. Mujeres embarazadas o en período de lactancia, o mujeres en edad fértil que no deseen utilizar medidas de prevención de embarazo.
    5. Pacientes que estén participando en otro ensayo clínico de investigación.
    6. Cualquier enfermedad o condición del paciente por la que, a juicio del investigador, no es adecuada la participación del paciente en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Aparición de insuficiencia renal o deterioro de la función renal respecto a la condición basal, definida como:
    Para pacientes con creatinina basal 7 mg/dL, un incremento de creatinina de 1,5 veces el valor basal.
    Para pacientes con creatinina basal <7 mg/dL, un incremento de creatinina de 2.0 veces el valor basal.

    - Aparición de efectos adversos relacionados con la infusión. Como tales se consideran los siguientes:
    1. Fiebre (Temperatura superior a 37.5º C durante la infusión o en las siguientes 3 horas tras la infusión).
    2. Escalofríos (durante la infusión).
    3. Exantema cutáneo (durante o tras la infusión).
    4. Flushing facial (durante la infusión).
    5. Dolor lumbar (durante la infusión).
    6. Dolor torácico (durante la infusión).
    7. Dolor abdominal (durante la infusión).
    8. Cefalea (durante la infusión).
    9. Cianosis periférica (durante la infusión).
    10. Hipoxemia (saturación de oxígeno < 90%) durante la infusión.
    11. Náuseas (durante la infusión).
    12. Vómitos (durante la infusión).
    13. Sudoración (durante la infusión).
    14. Hipotensión arterial (Tensión arterial sistólica < 100 mmHg durante la infusión).
    15. Hipertensión arterial (Tensión arterial sistólica >150 mmHg o diastólica > 100 mmHg durante la infusión).
    16. Taquicardia (frecuencia cardiaca > 110 latidos por minuto durante la infusión).
    E.5.1.1Timepoint(s) of evaluation of this end point
    A las dos semanas de finalización del tratamiento
    E.5.2Secondary end point(s)
    - Incidencia de discontinuación del tratamiento por aparición de acontecimientos adversos en las dos ramas del estudio.

    - Incidencia de toxicidad hepática en las dos ramas del tratamiento, definida como el incremento durante la profilaxis de los siguientes parámetros:
    ? Incremento del valor de las transaminasas (ALT o AST) de 3.0 veces el valor basal.
    ? Incremento del valor de la fosfatasa alcalina o Gamma-glutamil transpeptidasa de 1.5 veces el valor basal.

    - Incidencia de infección fúngica invasora precoz y tardía entre las dos ramas de tratamiento.
    Se define infección fúngica precoz como la aparición de infección fúngica en las 12 primeras semanas, e infección fúngica tardía la infección que aparece tras las 12 semanas hasta la semana 24 de seguimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    En los períodos marcados en la definición de las variables secundarias (ver respuesta a ítem anterior).
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned12
    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
    Se realizará un análisis estadístico intermedio con una muestra de 90 pacientes evaluables (45 por rama), cuando las dos terceras partes de la muestra total evaluable , es decir, 60 pacientes (30 por rama) hayan cubierto las 2 semanas de seguimiento después de la finalización del tratamiento antifúngico.
    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 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 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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state94
    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)
    Se atenderá al criterio del clínico.
    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 Decision2011-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
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