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    Summary
    EudraCT Number:2009-015863-15
    Sponsor's Protocol Code Number:TX-PULMON09
    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:2010-02-19
    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 number2009-015863-15
    A.3Full title of the trial
    ENSAYO CLÍNICO DE FASE II, ABIERTO, UNICÉNTRICO, PILOTO PARA EVALUAR LAS CARACTERÍSTICAS FARMACOCINÉTICAS, SEGURIDAD Y TOLERABILIDAD, TRAS LA CONVERSIÓN DE UN RÉGIMEN INMUNOSUPRESOR CON PROGRAF® A TACROLIMUS DE LIBERACIÓN PROLONGADA (ADVAGRAF®) EN PACIENTES CON TRASPLANTE PULMONAR ESTABLE
    A.4.1Sponsor's protocol code numberTX-PULMON09
    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 SponsorDr. Antonio Román Broto
    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 support
    B.4.2Country
    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.2.1.1.1Trade name ADVAGRAF 0,5 mg cápsulas duras de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA EUROPE, B.V.
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTACROLIMUS
    D.3.9.3Other descriptive nameTACROLIMUS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number0.5
    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.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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    PACIENTES CON TRASPLANTE PULMONAR ESTABLE
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar y comparar el perfil farmacocinético de tacrolimus en pacientes con trasplante de pulmón estable tras la conversión 1:1 de tacrolimus (Prograf®) a tacrolimus de liberación prolongada (Advagraf®).
    E.2.2Secondary objectives of the trial
    Conocer la incidencia de rechazo agudo por biopsia durante los 6 meses post-conversión.
    Determinar el perfil de seguridad del tratamiento con Advagraf®.
    Conocer el porcentaje de pacientes que presentan acontecimientos adversos de tacrolimus liberación prolongada (Advagraf®) que causan hospitalización durante los 6 meses post-conversión
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes con edades comprendidas entre 18 y 65 años, ambas inclusive.
    2. Pacientes con un trasplante pulmonar realizado al menos 6 meses antes.
    3. Pacientes que reciban una pauta inmunosupresora basada en Prograf® y en los que esté previsto continuar con el tratamiento un mínimo de 4 semanas.
    4. Pacientes que en fase estable tengan unas concentraciones mínimas de tacrolimus en sangre completa de 5-15 microg/L determinadas en dos ocasiones independientes con una separación de al menos 6 días durante el periodo de selección.
    5. Pacientes capaces de entender los propósitos y riesgos del estudio, que hayan sido informados y que otorguen el consentimiento informado por escrito para participar en el estudio
    E.4Principal exclusion criteria
    1. Pacientes con neoplasia o antecedentes de neoplasia en los cinco años anteriores, excepto carcinoma basocelular o epidermoide no metastásico tratado satisfactoriamente.
    2. Pacientes con infección generalizada que requieren tratamiento.
    3. Pacientes con diarrea severa, vómitos, úlcera péptica activa o trastornos digestivos que puedan afectar la absorción de tacrolimus.
    4. Pacientes en los que esté contraindicado el tratamiento con Advagraf® o Prograf® según ficha técnica.
    5. Existencia de un episodio de rechazo agudo en los tres meses previos.
    6. Rechazo crónico diagnosticado.
    7. Cirrosis hepática probada histológicamente.
    8. Pacientes que presenten una función pulmonar no aceptable.
    9. GPT/ALAT, GOT/ASAT, bilirrubina total superior o igual a 3 ULN.
    10. Creatinina sérica >17.680 mg/dL.
    11. Pacientes que han necesitado de dispositivo de asistencia ventricular
    12. Pacientes con alguna toxicomanía, trastorno psiquiátrico o afección que, según el criterio del investigador, pueda dificultar la participación.
    13. Pacientes que participan simultáneamente o han participado en otro estudio de investigación en los 28 días previos a la entrada en este estudio.
    14. Pacientes VIH positivos.
    15. Mujeres en edad fértil que no utilicen métodos anticonceptivos eficaces, gestantes, con sospecha de embarazo* o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    La eficacia del tratamiento se determinará a través de los parámetros farmacocinéticos siguientes:

    AUC0-24
    Cmax, Cmin
    Tmax
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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.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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    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
    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 months1
    E.8.9.1In the Member State concerned 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) 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 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 state20
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 20
    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 Decision2010-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-29
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