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    The EU Clinical Trials Register currently displays   37227   clinical trials with a EudraCT protocol, of which   6125   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-018141-20
    Sponsor's Protocol Code Number:IN0901INT
    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:2010-05-03
    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 number2009-018141-20
    A.3Full title of the trial
    Eficacia y Seguridad del Tratamiento a Largo Plazo (6 meses) con Innohep® frente a Anticoagulación con un Antagonista de la Vitamina K (Warfarina) para el Tratamiento del Tromboembolismo Venoso Agudo en Pacientes con Cáncer

    Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation with a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
    A.4.1Sponsor's protocol code numberIN0901INT
    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 SponsorLEO Pharma A/S
    B.1.3.4CountryDenmark
    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 INNOHEP 20.000 UI anti-Xa/ml, solución inyectable en jeringas
    D.2.1.1.2Name of the Marketing Authorisation holderLEO PHARMACEUTICAL PRODUCTS
    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 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 INNTINZAPARINA SODICA
    D.3.9.3Other descriptive nameTINZAPARINA SODICA
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20000
    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.IMP: 2
    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 Marevan
    D.2.1.1.2Name of the Marketing Authorisation holderGoldshield Pharmaceuticals Ltd
    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.3.4Pharmaceutical form 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 INNWarfarina Sodica
    D.3.9.1CAS number 129-06-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 3
    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 Marevan
    D.2.1.1.2Name of the Marketing Authorisation holderGoldshield Pharmaceuticals Ltd
    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.3.4Pharmaceutical form 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 INNWARFARINA SODICA
    D.3.9.1CAS number 129-06-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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.IMP: 4
    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 Marevan
    D.2.1.1.2Name of the Marketing Authorisation holderGoldshield Pharmaceuticals Ltd
    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.3.4Pharmaceutical form 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 INNWARFARINA SODICA
    D.3.9.1CAS number 129-06-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Tromboembolismo venoso (TEV) en pacientes con cáncer activo.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10066899
    E.1.2Term Venous thromboembolism
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del estudio es evaluar la eficacia de Innohep® en la prevención de la recurrencia de TEV en pacientes con cáncer activo que han presentado un episodio agudo de TEV.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios son:
    • Evaluar la seguridad del tratamiento a largo plazo con Innohep®.
    • Identificar los factores clínicos de riesgo de TEV recurrente y sangrado importante.
    • Evaluar la mortalidad global a los 6 meses.
    • Identificar el posible papel de los parámetros de la coagulación en la predicción de TEV recurrente o del pronóstico.
    • Evaluar la incidencia y la severidad del síndrome postrombótico (SPT).
    • Evaluar la calidad de vida (CdV) relacionada con la salud.
    • Evaluar la utilización de recursos sanitarios.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes con diagnóstico de cáncer activo con una neoplasia hematológica o un tumor sólido diagnosticado histológicamente o citológicamente (evidencia de estadío precoz, enfermedad regional o metastásica). El cáncer activo se define como:
    • Pacientes diagnosticados de cáncer en los últimos 6 meses, O
    • Pacientes con enfermedad recidivante, avanzada o metastásica, O
    • Pacientes que hayan recibido cualquier tratamiento para el cáncer durante los 6 meses previos, O
    • Pacientes que no estén en remisión completa de una neoplasia hematológica crónica.
    2. Trombosis venosa profunda (TVP) de extremidades inferiores proximal aguda confirmada objetivamente y sintomática (incluyendo anatómicamente poplítea, femoral [superficial y común] e ilíaca [externa y común]) y/o embolia pulmonar (EP) (localizada en arterias pulmonares segmentarias o mayores) diagnosticada en las 72 horas previas a la aleatorización. El diagnóstico de TVP/EP (en la aleatorización y en la recurrencia) debe realizarse mediante radiología objetiva adecuada (véase la Sección 10.7.3.4).
    3. &#8805; 18 años de edad o mayor de la edad legal para otorgar su consentimiento de acuerdo con las regulaciones específicas del país.
    4. Pacientes con estado funcional del Grupo Oncológico Cooperativo del Este de Estados Unidos (ECOG) de 0, 1 o 2 antes del episodio de TEV.
    5. Consentimiento informado firmado.
    E.4Principal exclusion criteria
    1. Esperanza de vida < 6 meses.
    2. Pacientes con carcinoma basocelular o cáncer cutáneo no melanoma.
    3. Aclaramiento de creatinina &#8804; 20 ml/min ; de acuerdo con la fórmula de Modificación de la Dieta en la Enfermedad Renal abreviada (MDERa) (véase el Apéndice V).
    4. Contraindicaciones de la anticoagulación:
    a. Sangrado clínicamente significativo activo o reciente (< 1 mes), incluyendo sangrado gastrointestinal o úlcera péptica.
    b. Antecedentes de trastorno hemorrágico o coagulopatía (congénita, adquirida o episodios repetidos de sangrado no explicado).
    c. Hipertensión arterial no controlada (presión arterial sistólica > 180 mm Hg o presión arterial diastólica > 110 mm Hg).
    d. Hemorragia intracraneal reciente (en el último mes previo a la aleatorización) con riesgo elevado de nuevo sangrado y que prohibiría la terapia anticoagulante, de acuerdo con el criterio del Investigador.
    e. Cirugía cerebral, de columna u oftálmica reciente (en el último mes previo a la aleatorización).
    f. Trombocitopenia (recuento de plaquetas < 50 x 109/ l).
    g. Coagulopatía debida a insuficiencia hepática indicada por un tiempo de tromboplastina parcial activada (TTPa) basal prolongado > 1,5 x límite superior normal (LSN) o equivalente a un cociente del TTPa > 1,5 (si no está recibiendo heparina de bajo peso molecular [HBPM] /heparina no fraccionada [HNF])
    5. Hipersensibilidad conocida al producto en investigación (Innohep®) o al producto de referencia (warfarina).
    6. Antecedentes de trombocitopenia inducida por heparina (TIH).
    7. Tratamiento anticoagulante terapéutico previo a la aleatorización para un TEV agudo administrado durante más de 72 horas antes de la aleatorización.
    8. Pacientes que han estado recibiendo anticoagulación terapéutica en el momento del episodio de TEV (o sea, fracaso del anticoagulante), usando cualquier anticoagulante, como:
    a. Anticoagulantes parenterales, p.ej. HNF, HBPM, fondaparinux, bivalirudina o hirudina.
    b. Antagonistas de la vitamina (AVK).
    c. Nuevos anticoagulantes orales, p.ej. dabigatran, rivaroxaban.
    Nota: Se permite el tratamiento crónico con fármacos antiplaquetarios como dosis bajas de aspirina (hasta 325 mg/día), clopidogrel o ticlopidina).
    9. Pacientes que es improbable que cumplan con el protocolo, p.ej. incapacidad para acudir a las visitas del estudio o incapacidad para recibir/administrar las inyecciones subcutáneas (SC) diarias.
    10. Participación en otro estudio intervencional con un tratamiento farmacológico activo o un dispositivo en investigación.
    11. Mujeres embarazadas o en periodo de lactancia. El estado del embarazo se deberá comprobar mediante pruebas de embarazo en suero o en orina antes de la inclusión.
    12. Mujeres potencialmente fértiles no protegidas mediante un método anticonceptivo efectivo (definido como anticoncepción en el Formulario de Consentimiento Informado [FCI]) durante todo el estudio.
    13. Hombres fértiles sexualmente activos si ellos o sus parejas (que sean mujeres potencialmente fértiles) no están usando control de natalidad efectivo.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia es una variable compuesta representada por el tiempo en días desde la aleatorización hasta la primera aparición de cualquiera de los siguientes 5 componentes documentados objetivamente:

    • TVP no mortales sintomáticas.
    • EP no mortales sintomáticas.
    • EP mortal.
    • TVP proximal incidental (en la vena poplítea o superior).
    • EP proximal incidental (en arterias segmentarias o mayores).

    Para el análisis se utilizarán los resultados de la adjudicación central de eventos.
    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 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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA94
    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 years2
    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 years2
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 532
    F.4.2.2In the whole clinical trial 1000
    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 Decision2010-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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