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    Summary
    EudraCT Number:2007-003718-32
    Sponsor's Protocol Code Number:BAY 79-4980 / 12781
    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:2008-01-02
    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 number2007-003718-32
    A.3Full title of the trial
    Ensayo clínico, controlado , doble ciego, paralelo, para evaluar la eficacia y seguridad del tratamiento profiláctico con BAY 79-4980 administrado una vez por semana, comparado con el tratamiento con rFVIII-FS administrado tres veces por semana, en pacientes con hemofilia A severa previamente tratados.
    A.4.1Sponsor's protocol code numberBAY 79-4980 / 12781
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 nameBAY 79-4980
    D.3.2Product code BAY 79-4980
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 alpha
    D.3.9.2Current sponsor codeBAY 14-2222
    D.3.9.3Other descriptive namerFVIII
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNoctocog alpha
    D.3.9.2Current sponsor codeBAY 14-2222
    D.3.9.3Other descriptive namerFVIII
    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 Yes
    D.3.11.13.1Other medicinal product typeproducto recombinante biotecnológico
    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 Kogenate Bayer
    D.2.1.1.2Name of the Marketing Authorisation holderBayer HealthCare AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameKogenate Bayer
    D.3.2Product code BAY 14-2222
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 alpha
    D.3.9.2Current sponsor codeBAY 14-2222
    D.3.9.3Other descriptive namerFVIII
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNoctocog alpha
    D.3.9.2Current sponsor codeBAY 14-2222
    D.3.9.3Other descriptive namerFVIII
    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 Yes
    D.3.11.13.1Other medicinal product typeproducto recombinante biotecnológico
    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 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 namerFVIII-FS reconstituido en 1% fosfatidilcolina- agente enmascarador de liposomas solo
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 alpha
    D.3.9.2Current sponsor codeBAY 14-2222
    D.3.9.3Other descriptive namerFVIII
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNoctocog alpha
    D.3.9.2Current sponsor codeBAY 14-2222
    D.3.9.3Other descriptive namerFVIII
    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 Yes
    D.3.11.13.1Other medicinal product typeproducto recombinante biotecnológico
    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 placeboPowder and solvent for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hemofilia A
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10060613
    E.1.2Term Hemophilia A (Factor VIII)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018937
    E.1.2Term Haemophilia A
    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 es evaluar el efecto del tratamiento profiláctico con BAY 79-4980 una vez por semana, comparado con el tratamiento profiláctico con rFVIII-FS-WFI tres veces por semana, en la protección frente a todo tipo de hemorragias
    E.2.2Secondary objectives of the trial
    El objetivo secundario es evaluar el efecto del tratamiento profiláctico con BAY 79-4980 una vez por semana, comparado con el tratamiento profiláctico con rFVIII-FS-WFI tres veces por semana, en la protección frente a las hemorragias articulares.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Varones de 12 a 70 años de edad, la inclusión de sujetos adolescentes empezará cuando 20 adultos hayan completado la fase de tratamiento supervisado con una tolerabilidad aceptable y el Comité de revisión de seguridad de datos lo apruebe.
    -Sujetos con hemofilia A grave (<1% FVIII:C).
    -Sujetos con un total de 150 DE o más a cualquier FVIII.
    -Sujetos que hayan recibido tratamiento a demanda (no más del 40% del total de participantes y al menos el 20% tendrán que sufrir hemorragias con gran frecuencia [≥ 20 hemorragias/año]) con un promedio mínimo de 1 hemorragia importante por mes o que hayan recibido tratamiento profiláctico secundario no más de 3x/semana con un historial clínico de un mínimo de 12 hemorragias importantes por año previo al inicio del tratamiento profiláctico secundario.
    -Sujetos con episodios hemorrágicos y/o tratamientos documentados en su historial médico durante los 6 meses previos a su inclusión en el estudio.
    -Sujetos sin actividad inhibidora apreciable mediante el ensayo de Bethesda modificado por Nijmegen (≥0,6 UB/mL se considera positivo) en dos muestras consecutivas y ausencia de signos clínicos o síntomas de reducción de la respuesta a la administración de FVIII. (Puede considerarse una primera muestra negativa antigua si ésta se ha obtenido durante los 3 meses previos al periodo de selección. La segunda muestra -de confirmación- debe ser analizada en todos los casos en el laboratorio central mediante la prueba de Nijmegen. Si no se dispone de una primera muestra reciente, entonces es necesario que se obtengan 2 muestras negativas en el laboratorio central, con al menos una semana de separación entre ellas). Deben haber pasado al menos 3 días sin haber recibido FVIII antes de la obtención de muestras para las pruebas de inhibidores; los casos limítrofes (valores entre ≥ 0,3 y < 0,6 UB).
    -Sujetos sin antecedentes de formación de anticuerpos inhibidores de FVIII. (≥0,6 UB/mL usando el ensayo de Bethesda modificado por Nijmegen; también son aptos los sujetos con un valor hemolítico histórico máximo de 1,0 UB en no más de una ocasión, calculado mediante el ensayo de Bethesda clásico, pero con al menos tres resultados negativos [<0,6 UB] posteriores consecutivos).
    - Sujetos que completen un entrenamiento con un DPE (diario del sujeto electrónico) y demuestren que pueden usarlo correctamente.
    -Consentimiento informado por escrito firmado por el sujeto y su progenitor/tutor legal, si < 18 años de edad.

    Sólo para sujetos incluidos en el perfil lipídico:
    -Los sujetos con perfil de colesterol- LDL y colesterol total normales, previo a su inclusión en el estudio, que no estén recibiendo fármacos hipolipidemiantes.
    -Sujetos que desean o pueden cumplir los requisitos de ayuno.
    -Ayuno nocturno de 12 horas seguido por un ayuno adicional de 3 horas tras la inyección. Los sujetos sólo pueden consumir agua durante este período.
    E.4Principal exclusion criteria
    -Sujetos que estén recibiendo profilaxis primaria (inicio del tratamiento profiláctico antes o inmediatamente después de la primera hemorragia articular sin interrupciones relevantes).
    -Sujetos en profilaxis que requieran > 75 UI/Kg/semana.
    -Sujetos con cualquier otra dolencia hemorrágica además de hemofilia A (es decir, enfermedad de von Willebrand).
    -Sujetos con trombocitopenia (plaquetas < 100.000/mm3).
    -Sujetos con función renal anómala (creatinina sérica > 2,0 mg/dL).
    -Sujetos con enfermadea hepática activa (AST o ALT >5xLSN).
    -Sujetos en tratamiento con fármacos inmunomoduladores durante los 3 meses previos a la inclusión o durante el estudio (se permiten los siguientes medicamentos: Tratamiento con interferón alfa para el VHC, terapia TARGA para el VIH y/o un total de dos tandas de tratamiento con esteroides en pulsos durante un máximo de 7 días a 1 mg/kg o menos).
    -Sujetos con un recuento absoluto de linfocitos CD4 < 250 células/mm3.
    -Sujetos con anticuerpos positivos para Lupus o que tengan algún positivo en su historial.
    -Sujetos con hipersensibilidad conocida al principio activo, a las proteínas de ratón o hámster, a los liposomas o al PEG.
    -Sujetos con dislipidemia grave por cualquier causa (LDL-C ≥ 190 mg/dL).
    -Sujetos que estén recibiendo o hayan recibido otros fármacos experimentales durante los 3 meses previos a su inclusión en el estudio.
    -Sujetos que necesiten cualquier tipo de medicación previa para tolerar las inyecciones de FVIII (p.ej. antihistamínicos).
    -Sujetos con hipertensión no controlada (presión arterial diastólica > 100 mmHg).
    -Sujetos con angina coronaria inestable y/o historia clínica de infarto de miocardio.
    -Sujetos que no estén dispuestos a cumplir con las visitas planificadas para el estudio o con las pautas de tratamiento.
    -Sujetos para los que se ha planificado una cirugía mayor (incluida la ortopédica) o sinovectomía radioisotópica durante el estudio.
    -Sujetos que, en opinión del investigador, no sean adecuados para este estudio por cualquier otro motivo.

    Sólo para sujetos incluidos en el sub-estudio farmacocinético:
    -Sujetos que hayan recibido cualquier tipo de medicación pegilada (como interferón PEG) en el mes previo a la sesión de farmacocinética.
    E.5 End points
    E.5.1Primary end point(s)
    El principal criterio de valoración de la eficacia será el porcentaje de sujetos con una cantidad total de hemorragias inferior a 9 por año. Las 3 semanas de fase de tratamiento supervisado no serán consideradas para el análisis de eficacia.
    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 No
    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 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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    está indicado en el protocolo
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 250
    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 Decision2008-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-05
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