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    Summary
    EudraCT Number:2010-019987-35
    Sponsor's Protocol Code Number:20080435
    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:2010-08-31
    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 number2010-019987-35
    A.3Full title of the trial
    Estudio de fase 2, intervencionista, de un solo brazo para describir la respuesta plaquetaria y las tasas de remisión de PTI en sujetos adultos con Púrpura Trombocitopénica Inmune que reciben Romiplostim.
    -------------------------------------------------------
    A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim
    A.4.1Sponsor's protocol code number20080435
    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 SponsorAmgen Inc
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name NPLATE 500 microgramos polvo para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN 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 Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/008/05
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROMIPLOSTIM
    D.3.9.3Other descriptive nameROMIPLOSTIM
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Púrpura Trombocitopénica Inmune
    (Idiopática) (PTI) en adultos
    ----------------------------------
    Adult immune thrombocytopenic purpura (ITP)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10021245
    E.1.2Term Idiopathic thrombocytopenic purpura
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Describir el número de meses con una respuesta plaquetaria del sujeto en un periodo de tratamiento de 12 meses.
    E.2.2Secondary objectives of the trial
    - Describir la incidencia de remisión de la PTI en los sujetos.
    -Describir la incidencia de esplenectomía en los sujetos.
    -Describir la incidencia de acontecimientos adversos en los sujetos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    El sujeto ha sido diagnosticado con PTI primaria según las guías de la ASH (George et al, 1996) y solo ha recibido previamente tratamientos de primera línea.
    El tratamiento de primera línea se define como corticosteroides, IGIV, anti-D y alcaloides de la vinca (utilizados solo para el tratamiento de la PTI relacionada con trombocitopenia). Una transfusión de plaquetas en cualquier momento durante el periodo de seis meses a partir del diagnóstico original no excluiría al sujeto del estudio.
    -Diagnóstico inicial de PTI primaria en los 6 meses previos a la inclusión.
    -Edad >= 18 años en el momento de la selección.
    -Un único recuento plaquetario <= 30 x 109/L en cualquier momento durante el periodo de selección.
    -El sujeto o su representante legalmente aceptable ha proporcionado el consentimiento informado.
    E.4Principal exclusion criteria
    Antecedentes conocidos de trastorno de las células madre de la médula ósea.
    -- Cualquier resultado anómalo de la médula ósea aparte de las típicos de la PTI debe ser aprobado por Amgen antes de incluir a un sujeto en el estudio.
    -Resección quirúrgica del bazo.
    -El sujeto tiene antecedentes de cáncer o neoplasias actuales diferentes al carcinoma de células basales o al cáncer cervical in-situ con tratamiento activo o enfermedad en los 5 años previos a la selección.
    -Antecedentes conocidos de trombocitopenia congénita.
    -Antecedentes conocidos de hepatitis B, hepatitis C o virus de la inmunodeficiencia humana.
    -H. pylori positivo mediante prueba del aliento con urea o prueba de antígenos en heces en el momento de la selección.
    - Antecedentes conocidos de lupus eritematoso sistémico, síndrome de Evans o neutropenia autoinmune.
    - Antecedentes conocidos de síndrome de anticuerpos antifosfolípidos o anticoagulante lúpico positivo.
    - Antecedentes conocidos de coagulación intravascular diseminada, síndrome urémico hemolítico o púrpura trombocitopénica trombótica.
    -Antecedentes de tromboembolismo venoso recurrente o acontecimientos trombóticos o una aparición en los 5 años previos a la inclusión.
    - Uso previo de romiplostim, PEG-rHuMGDF, eltrombopag, rHuTPO o cualquier agente productor de plaquetas.
    -Rituximab (para cualquier indicación) o mercaptopurina (6-MP) o uso previsto durante el tiempo del estudio propuesto.
    - Todos los factores de crecimiento hematopoyético, incluido IL-11 (oprelvekina) en las 4 semanas previas a la visita de selección.
    - Uso de agentes alquilantes en cualquier momento antes o durante la visita de selección o previsto durante el tiempo del estudio propuesto.
    - El sujeto presenta hipersensibilidad conocida a cualquier producto recombinante derivado de E coli (por ejemplo, Infergen(R), Neupogen(R), somatropina y Actimmune).
    - Incluido actualmente en otro estudio de investigación de un fármaco o dispositivo, o han pasado menos de 30 días desde el fin de otro estudio de investigación de un fármaco o dispositivo, o recibe otro/s producto/s en investigación.
    - El sujeto será sometido a otros procedimientos de investigación mientras participe en este estudio clínico.
    - Mujer embarazada o en periodo de lactancia, o que planee quedarse embarazada en las 5 semanas posteriores al fin del tratamiento.
    - Mujer en edad fértil que no desea utilizar, con su pareja, métodos anticonceptivos altamente eficaces durante el tratamiento y durante los 5 meses posteriores al fin del tratamiento.
    -El sujeto ha participado previamente en un estudio con romiplostim.
    - Según informan el sujeto y el investigador, el sujeto no estará disponible para las visitas de estudio requeridas por el protocolo.
    -El sujeto presenta un trastorno de cualquier tipo que, según el criterio del investigador, puede comprometer su capacidad para proporcionar el consentimiento informado escrito y/o cumplir con los procedimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    la variable principal es el número de meses con respuesta plaquetaria durante el periodo de tratamiento de 12 meses. Una respuesta plaquetaria durante cualquier mes se define como la mediana de recuentos plaquetarios medidos en el mes >= 50 x 109/L.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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
    el tiempo desde el primer sujeto seleccionado hasta la visita de EOT del último sujeto, la duración del estudio será aproximadamente de 27 meses hasta su finalización.
    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 months10
    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 months10
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 75
    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 Decision2010-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-26
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