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    The EU Clinical Trials Register currently displays   42314   clinical trials with a EudraCT protocol, of which   6969   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-005851-40
    Sponsor's Protocol Code Number:TPL104054
    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:2008-03-12
    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 number2007-005851-40
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico para evaluar la seguridad y eficacia de Eltrombopag para reducir la necesidad de transfusión de plaquetas en sujetos trombocitopénicos con enfermedad hepática crónica que se van a someter a un procedimiento invasivo programado.
    A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects with Chronic Liver Disease Undergoing Elective Invasive Procedures.
    A.3.2Name or abbreviated title of the trial where available
    ELEVATE
    A.4.1Sponsor's protocol code numberTPL104054
    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 SponsorGlaxoSmithKline S.A. España
    B.1.3.4CountrySpain
    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.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 No
    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 nameEltrombopag
    D.3.2Product code SB-497115
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNEltrombopag
    D.3.9.2Current sponsor codeSB-497115
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    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
    Sujetos trombocitopénicos con enfermedad hepática crónica que se van a someter a un procedimiento invasivo programado.
    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
    Demostrar la capacidad de eltrombopag, comparado con placebo, de reducir la proporción de pacientes con hepatopatía crónica y trombocitopenia (plaquetas <50.000/microlitro) que reciben transfusiones de plaquetas antes, durante y hasta siete días después de los procedimientos invasivos programados.
    To demonstrate the ability of eltrombopag, compared to placebo to reduce the proportion of subjects with chronic liver disease and thrombocytopenia (platelets <50,000/microL) who receive platelet transfusions administered prior to, during and up to seven days following elective invasive procedures.
    E.2.2Secondary objectives of the trial
    Evaluar el efecto de eltrombopag en la proporción de pacientes con hemorragia antes, durante y hasta siete días después de los procedimientos invasivos programados.
    Evaluar seguridad y tolerabilidad de eltrombopag una vez al día a pacientes trombocitopénicos con hepatopatía crónica antes, durante y después de los procedimientos invasivos programados.
    Demostrar la capacidad de eltrombopag comparado con placebo para reducir las transfusiones de plaquetas antes, durante y hasta 30 días después de los procedimientos en pacientes con hepatopatía crónica y un recuento basal de plaquetas <50.000/microL.
    Evaluar el efecto de eltrombopag en la utilización de recursos médicos y recuentos de plaquetas antes, durante y hasta 30 días después de los procedimientos invasivos programados.
    Describir la farmacocinética de eltrombopag y la relación entre la FC y las correspondientes variables de seguridad y eficacia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombres y mujeres, de edad ≥18 años con hepatopatía crónica.
    2. Puntuación de Child-Pugh de <=12.
    3. Puntuación del Modelo de Hepatopatía Terminal (MELD) de <= 24.
    4. Pacientes candidatos para someterse a un procedimiento invasivo programado y que requieran transfusión de plaquetas.
    5. Recuento basal de plaquetas <50.000/microL.
    6. Nivel basal de sodio en sangre >130mEq/L.
    7. Concentración de hemoglobina >8g/dL estable durante al menos un mes.
    8. Una mujer es elegible si:
    No es fértil, lo que incluye a toda mujer con:
    • Histerectomía
    • Ovariectomía bilateral
    • Ligadura bilateral de trompas
    • Postmenopausia (determinada por cese total de menstruación durante más de un año)
    Es fértil, presenta una prueba de embarazo en orina y/o suero en la selección y en el periodo de 24 horas previo a la primera dosis del producto en investigación, y usa uno de los siguientes métodos anticonceptivos aceptables:
    • Abstinencia completa de relaciones sexuales durante dos semanas antes de la exposición al fármaco, durante todo el estudio clínico y durante los 28 días posteriores a la finalización o terminación prematura del estudio, para tener en cuenta la eliminación del fármaco del estudio (mínimo de 5 semividas).
    • Cualquier dispositivo intrauterino (DIU) con una tasa de fracaso documentada menor de 1% al año.
    • Anticoncepción de doble barrera (preservativo con gel espermicida o diafragma con espermicida).
    • Pareja masculina que sea estéril (diagnosticado por un profesional médico cualificado) antes de la entrada de la paciente en el estudio, siendo ésta la única pareja sexual de la paciente.
    • Anticonceptivos orales (combinados o solamente progesterona).
    • Cualquier otro método anticonceptivo con una tasa de fracaso documentado <1% al año.
    9. El paciente no tiene limitación física para ingerir o retener medicación oral.
    10. El paciente puede comprender y cumplir con los requisitos del protocolo.
    11. El paciente puede otorgar su consentimiento informado por escrito y fechado.
    E.4Principal exclusion criteria
    1. Pacientes con hipersensibilidad, intolerancia o alergia conocidas a cualquiera de los ingredientes de los comprimidos de eltrombopag.
    2. Evidencia de trombosis de la vena porta en imágenes abdominales en los 3 meses previos al comienzo del estudio.
    3. Antecedentes de trombosis arterial o venosa, incluido el síndrome de Budd-Chiari, Y ≥ dos de los siguientes factores de riesgo: trastornos trombofílicos hereditarios (como Factor V Leiden, deficiencia de ATIII, etc.), terapia hormonal sustitutiva, tratamiento anticonceptivo sistémico (con estrógenos), tabaquismo, diabetes, hipercolesterolemia, medicación para hipertensión o cáncer.
    4. Cualquier condición patológica asociada a una hemorragia presente activa de Grado 3 o 4 de la OMS.
    5. Infección activa que precise tratamiento antibiótico sistémico. Se permite el empleo profiláctico de antibióticos.
    6. Mujeres embarazadas o en periodo de lactancia.
    7. Tratamiento con un fármaco en investigación en los 30 días o cinco semividas (el periodo que sea más largo) antes de la primera dosis de medicación del estudio.
    8. Antecedentes de anomalías de la agregación plaquetaria que impidan una medición fiable del número de plaquetas.
    9. Antecedentes de porfiria.
    10. Participación previa en el estudio TPL104054.
    E.5 End points
    E.5.1Primary end point(s)
    Proporción de pacientes con hepatopatía crónica y trombocitopenia (plaquetas <50.000microL) que no precisen una transfusión de plaquetas antes, durante y hasta siete días después de los procedimientos invasivos programados.
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Platelet Function Test
    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) 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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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.1.3Elderly (>=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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 500
    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 Decision2008-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-15
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