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    Summary
    EudraCT Number:2010-020558-33
    Sponsor's Protocol Code Number:997HA301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-02-22
    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 number2010-020558-33
    A.3Full title of the trial
    A-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A
    A-LONG: Evaluación abierta y multicéntrica de la seguridad, la farmacocinética y la eficacia de la proteína de fusión Factor VIII Fc recombinante (FVIIIrFc) en la prevención y el tratamiento de las hemorragias en sujetos con hemofilia A grave tratados previamente
    A.3.2Name or abbreviated title of the trial where available
    A-LONG
    A.4.1Sponsor's protocol code number997HA301
    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 SponsorBiogen Idec Hemophilia, 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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/783
    D.3 Description of the IMP
    D.3.1Product namerecombinant Factor VIII-Fc
    D.3.2Product code rFVIIIFc
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBIIB031
    D.3.9.3Other descriptive namerFVIIIFc, recombinant Factor VIII Fc
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/783
    D.3 Description of the IMP
    D.3.1Product namerecombinant Factor VIII-Fc
    D.3.2Product code rFVIIIFc
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBIIB031
    D.3.9.3Other descriptive namerFVIIIFc, recombinant Factor VIII Fc
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(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.IMP: 3
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/783
    D.3 Description of the IMP
    D.3.1Product namerecombinant Factor VIII-Fc
    D.3.2Product code rFVIIIFc
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBIIB031
    D.3.9.3Other descriptive namerFVIIIFc, recombinant Factor VIII Fc
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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: 4
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/783
    D.3 Description of the IMP
    D.3.1Product namerecombinant Factor VIII-Fc
    D.3.2Product code rFVIIIFc
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBIIB031
    D.3.9.3Other descriptive namerFVIIIFc, recombinant Factor VIII Fc
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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: 5
    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 ADVATE 1000 UI polvo y disolvente para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER, AG
    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 Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOCTOCOG ALFA
    D.3.9.3Other descriptive nameOCTOCOG ALFA
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    Severe hemophilia A - defined as <1 IU/dL (<1%) endogenous FVIII

    Hemofilia A
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10018937
    E.1.2Term Haemophilia A
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10056493
    E.1.2Term Haemophilia A without inhibitors
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10053753
    E.1.2Term Hemophilia A without inhibitors
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10060612
    E.1.2Term Hemophilia A
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la seguridad y la tolerabilidad de FVIIIrFc administrado
    como profilaxis, semanalmente, a demanda y para intervenciones quirúrgicas.
    Evaluar la eficacia del tratamiento preventivo personalizado con
    FVIIIrFc (grupo 1).
    Evaluar la eficacia de FVIIIrFc administrado a demanda (grupo
    y como tratamiento quirúrgico.
    E.2.2Secondary objectives of the trial
    Caracterizar el perfil FC de FVIIIrFc y comparar la
    farmacocinética de FVIIIrFc con la del producto comercializado actualmente, Advate.
    Caracterizar el intervalo de dosis y las pautas necesarias para
    prevenir adecuadamente la hemorragia con una pauta
    preventiva; mantener la hemostasia en intervenciones
    quirúrgicas; o tratar episodios hemorrágicos a demanda,
    semanalmente o como prevención.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Otorgar el consentimiento informado por escrito y cualquier autorización que se exija en las leyes locales (por ejemplo,Protected Health Information [PHI]). En el caso de los pacientes menores de 18 años, se precisa el consentimiento del progenitor o del tutor. Los pacientes de menos de 18 años deben otorgar su consentimiento para el estudio, firmando un documento de asentimiento si así lo exige la normativa local. 2.Varones, > o = 12 años de edad y peso superior a 40 kg. 3.Padecer hemofilia A grave, definida como < 1 UI/dl (<1 %) de FVIII endógeno, determinado mediante análisis de la coagulación en una fase realizado en el laboratorio central en la selección. Si el resultado de la selección es > o = 1 %, la gravedad de la hemofilia A podrá confirmarse mediante datos anteriores de un laboratorio clínico certificado que demuestren FVIII:C <1 % según lo determinado por la prueba de coagulación en una fase recogida en la historia clínica, o mediante un genotipo documentado que produce hemofilia A grave.4.Pacientes tratados previamente, que se definen como aquellos que cuenten con documentación de haber estado expuestos durante un mínimo de 150 días a cualquier tipo de FVIII recombinante o derivado del plasma o a crioprecipitados el día 0 (Advate o FVIIIrFc). El tratamiento con plasma en fresco congelado no debe considerarse en el recuento de los días de exposición documentados5.Sin actividad de inhibidores mensurable con la prueba de Bethesda con modificación de Nimega (se considera positivo > o = 0,6 unidades de Bethesda [UB]/ml) en 2 muestras consecutivas y ausencia de signos o síntomas clínicos de disminución de la respuesta a la administración de FVIII. (La primera muestra negativa puede ser anterior, si se ha obtenido en las 12 semanas previas a la selección). La segunda muestra de confirmación debe obtenerla el laboratorio central con la prueba de Bethesda modificada por Nimega. Si no se dispone de muestras recientes,se obtendrán dos muestras (con una semana de diferencia como mínimo) durante la selección, que deberán dar un resultado negativo en el análisis del laboratorio central). Deberá haber transcurrido un período de lavado de FVIII de 96 horas como mínimo antes de obtener las muestras para los análisis de inhibidores si es posible (se permite otro período de lavado de 72 horas si se trata un episodio hemorrágico sufrido por el paciente antes de las 96 horas) 6.Ausencia de antecedentes de formación de anticuerpos inhibidores de FVIII (> o = 0,6 UB/ml en la prueba de Bethesda modificada por Nimega; también podrán participar los pacientes que hayan presentado en algún momento un título máximo de 1,0 UB en no más de una ocasión con la prueba de Bethesda clásica, y al menos 2 resultados negativos sucesivos [< 0,6 UB]). 7.Antecedentes de episodios de hemorragia o de tratamiento con FVIII en las 12 últimas semanas, documentados en la historia clínica. 8.Disposición y capacidad del paciente o de un representante (un cuidador o un familiar > o = 18 años) para recibir formación sobre el uso del DEP y para cumplimentarlo durante todo el estudio 9.En los pacientes que participen en el grupo 1: Tratamiento en la actualidad con una pauta preventiva con un producto de FVIII al menos dos veces por semana o con una pauta a demanda, con > o = 12 episodios hemorrágicos en los 12 meses anteriores al día 0 (Advate o FVIIIrFc).10.En los pacientes que participen en los grupos 2 o 3:Tratamiento en la actualidad con una pauta a demanda con > o = 12 episodios hemorrágicos en los 12 meses anteriores al día 0 (FVIIIrFc). Los criterios de inclusión siguientes se refieren a las pruebas realizadas en el laboratorio central con muestras obtenidas en la selección y revisadas antes del día 0 (Advate o FVIIIrFc):11.Recuento de plaquetas > o = 100.000 células/µl 12. Cociente internacional normalizado (CIN) < o = 1,30, según la definición de normalidad del laboratorio que realiza la medición 13.Inmunocompetentes: Linfocitos CD4 > 200 mm3 14. Carga viral < 400 copias/ml si el paciente está infectado por el virus de la inmunodeficiencia humana (VIH)
    E.4Principal exclusion criteria
    1. Antecedentes o presencia en la actualidad de un título detectable
    de inhibidores definido por el laboratorio central (los antecedentes familiares de inhibidores no excluirán al paciente)2.Otros trastornos de la coagulación, además de la hemofilia A.3.Antecedentes de hipersensibilidad o anafilaxia asociadas a la
    administración de FVIII o de inmunoglobulinas IV. 4.Sólo en el subgrupo de FC: hipersensibilidad conocida a las proteínas de ratón o de hámster. 5.Tratamiento en la actualidad (o que probablemente lo vaya a necesitar en el estudio) con ácido acetilsalicílico (AAS) o ibuprofeno (se permiten otros antiinflamatorios no esteroideos).6.Tratamiento sistémico simultáneo con fármacos inmunodepresores en las 12 semanas previas al día 0 (Advate o FVIIIrFc) (excepciones: ribavirina, tratamiento de la infección por el virus de la hepatitis C [VHC] y el VIH o corticosteroides sistémicos [un total de 2 ciclos de tratamientos con pulsos de < o = 1 mg/kg en un plazo de 7 días] o esteroides inhalados).7.Intervención de cirugía mayor en las 8 semanas previas.8.Incapacidad de anotar información exacta y oportuna sobre las inyecciones y los episodios hemorrágicos en un DEP y carencia de un progenitor/cuidador adecuado que se ocupe de ello (según el criterio del investigador).9.El paciente no puede o no quiere dejar de tomar dosis adicionales preventivas de FVIII ante de realizar actividades deportivas o de un aumento de la actividad física.10.Participación actual o en los últimos 30 días en otro ensayo clínico con fármacos en investigación.11.Cualquier enfermedad importante clínicamente significativa concurrente o cualquier otro motivo no especificado que, en opinión del investigador, motive que el paciente no sea idóneo para participar en el estudio.Los criterios de exclusión siguientes se refieren a las pruebas realizadas en el laboratorio central con muestras obtenidas en la selección y revisadas antes del día 0 (Advate o FVIIIrFc):12.Función renal anómala (creatinina sérica > 2,0 mg/dl).13. Alanina transaminasa (ALT) o aspartato transaminasa (AST) séricas > 5 x límite superior de la normalidad (LSN).14. Bilirrubina sérica > 3 x LSN.
    E.5 End points
    E.5.1Primary end point(s)
    De la seguridad y tolerabilidad:
    - Variaciones clínicamente significativas de la exploración física
    y las constantes vitales con respecto al momento basal
    - Incidencia de acontecimientos adversos (AA), incluidos los
    valores analíticos anómalos con importancia clínica
    - Incidencia del desarrollo de inhibidores con el análisis de
    Bethesda modificado por Nimega
    De la eficacia:
    - Número anualizado de episodios hemorrágicos (espontáneos y
    traumáticos).
    - Los parámetros farmacocinéticos principales son las siguientes
    evaluaciones de la actividad de FVIII: área bajo la curva
    corregida en función de la dosis (AUC/dosis), semivida, TMP,
    CL y aumento de la recuperación en la prueba de coagulación de
    una fase.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    El elemento de cruce sólo se refiere al subgrupo de FC, en donde FC de FVIIIr se compara con Advate
    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 EEA40
    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
    Definido en la sección 7.5 del protocolo
    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 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 180
    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)
    Descrito en la sección 7.3.3 del protocolo
    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 Decision2011-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
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