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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2007-001516-24
    Sponsor's Protocol Code Number:20060197
    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:2009-12-23
    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 number2007-001516-24
    A.3Full title of the trial
    Estudio de extensión abierto para evaluar la seguridad de la administración a largo plazo de romiplostim en sujetos trombocitopénicos con síndromes mielodisplásicos (SMD)------------------

    An Opel Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects with Myelodysplastic Syndromes (MSD)
    A.4.1Sponsor's protocol code number20060197
    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 AuthorisationUnited Kingdom
    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 nameRomiplostim
    D.3.2Product code AMG 531
    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.3.9.2Current sponsor codeAMG 531
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Information not present in EudraCT
    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
    Trombocitopenia asociada con Síndromes Mielodisplásicos (SMD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028533
    E.1.2Term Myelodysplastic syndrome
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Proporcionar datos sobre la seguridad a largo plazo del uso de romiplostim en sujetos trombocitopénicos con SMD.-------------------------------------------------

    The primary objective is to provide long-term safety data for the use of romiplostim in thrombocytopenic subjects with myelodysplastic syndromes (MDS).
    E.2.2Secondary objectives of the trial
    Evaluar la efectividad de romiplostim con respecto a la respuesta plaquetaria, las transfusiones y los acontecimientos hemorrágicos en el tratamiento de sujetos trombocitopénicos con SMD.----------------

    The secondary objective is to evaluate the effectiveness of romiplostim with respect to platelet response, transfusion, and bleeding events in the treatment of thrombocytopenic subjects with MDS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    El sujeto ha finalizado un estudio de romiplostim para el tratamiento de la trombocitopenia en sujetos con SMD.
    El sujeto presenta un estado funcional ECOG de 0 a 2 (Eastern Cooperative Oncology Group).
    El sujeto tuvo un recuento plaquetario < ó = 50 x 10e9/L desde la dosis final del producto en investigación en el estudio original.
    El sujeto o su representante legalmente aceptable han proporcionado el consentimiento informado escrito antes de que se iniciara cualquier procedimiento específico del estudio.-----------------

    Subject completed a romiplostim study for the treatment of thrombocytopenia in subjects with MDS.
    Eastern Cooperative Oncology ( ECOG) performance status of 0-2.
    Subject had a platelet count of < ó = 50 x 10e9/L since the final dose of investigational product in the parent study.
    Subject or his/her legally acceptable representative provided written informed consent before any study-specific procedures were initiated.
    E.4Principal exclusion criteria
    Al sujeto se le ha diagnosticado LMA o presenta un recuento de blastos > ó = 10% en la biopsia de la médula ósea o sangre periférica.
    El sujeto tiene antecedentes de leucemia.
    El sujeto tiene antecedentes de trasplante de médula ósea o células madre.
    El sujeto presenta neoplasia maligna previa (distinta de cáncer cervical in situ, cáncer de próstata controlado o cáncer de piel de células basales), a no ser que el sujeto haya sido tratado con intención curativa y no presente indicios de enfermedad durante > ó = 3 años antes de la aleatorización.
    El sujeto presenta infecciones activas o no controladas.
    El sujeto presenta angina inestable, insuficiencia cardiaca congestiva [New York Heart Association (NYHA) > clase II], hipertensión no controlada (diastólica > 100 mmHg), arritmia cardiaca no controlada o infarto de miocardio reciente (menos de 1 año).
    El sujeto tiene antecedentes de trombosis arterial (por ejemplo, ictus o accidente isquémico transitorio) durante el último año.
    El sujeto tiene antecedentes de trombosis venosa que actualmente requiere tratamiento anticoagulante.
    El sujeto ha recibido interleucina (IL)-11 en las 4 semanas previas a la selección.
    El sujeto había recibido anteriormente un factor de crecimiento trombopoyético (distinto de romiplostim).
    El sujeto presenta hipersensibilidad conocida a cualquier producto derivado de Escherichia coli (E coli) recombinante (por ejemplo, Infergen®, Neupogen®, somatropina y Actimmune).
    Actualmente el sujeto está participando en (un) estudio(s) de dispositivos o fármacos en investigación, o aún no han pasado como mínimo 4 semanas desde la conclusión del estudio o estudios de dispositivos o fármacos en investigación (distinto del estudio original de romiplostim), o el sujeto está recibiendo otro(s) agente(s)/dispositivo(s) en investigación.
    El sujeto es una mujer en edad fértil con embarazo evidente (p. ej., prueba de la gonadotropina coriónica humana positiva [HCG]) o en periodo de lactancia.
    El sujeto no toma las precauciones anticonceptivas adecuadas.
    El sujeto presenta cualquier tipo de trastorno que compromete su capacidad de dar el consentimiento informado escrito (y no dispone de un representante legalmente aceptable) o no puede llevar a cabo los procedimientos del estudio.-----------------------------

    Subject has been diagnosed with AML or has a blast count > ó = 10% by peripheral blood or bone marrow biopsy
    Subject has a prior history of leukemia
    Subject has a prior history of bone marrow or stem cell transplantation
    Subject has a prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for > ó = 3 years before randomization
    Subject has active or uncontrolled infections
    Subject has unstable angina, congestive heart failure [New York Heart Association (NYHA) > class II], uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
    Subject has a history of arterial thrombosis (eg, stroke or transient ischemic attack) in the past year
    Subject has a history of venous thrombosis that currently requires anti-coagulation therapy
    Subject received interleukin (IL)-11 within 4 weeks of screening
    Subject previously received a thrombopoietic growth factor (other than romiplostim)
    Subject has a known hypersensitivity to any recombinant E coli-derived product (eg, Infergen®, Neupogen®, Somatropin, Actimmune)
    Subject is currently enrolled in investigational device or drug study(ies), has not yet completed at least 4 weeks since ending investigational device or drug study(ies) (other than parent romiplostim study), or subject is receiving other investigational agent(s)/device(s)
    Subject is of child-bearing potential and is evidently pregnant (eg, positive human chorionic gonadotropin [HCG] test) or is breast feeding
    Subject is not using adequate contraceptive precautions
    Subject has any kind of disorder that compromises his/her ability to give written informed consent (and does not have a legally acceptable representative) or is unable to comply with study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es la incidencia de acontecimientos adversos, incluidos los cambios clínicamente significativos en los valores analíticos y la incidencia de formación de anticuerpos.------------

    The primary endpoint is the incidence of all adverse events, including clinically significant changes in laboratory values and incidence of antibody formation.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    E.8.9.2In all countries concerned by the trial months6
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 250
    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)
    Cada paciente realizará una visita de fin de estudio cuatro semanas tras la última dosis del Producto en Investigación.--------------------------------------------

    Each subject will undergo an End of Study visit four weeks after the last dose of Investigational Product.
    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 Decision2010-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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