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    Summary
    EudraCT Number:2011-000410-18
    Sponsor's Protocol Code Number:061002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-12-07
    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 number2011-000410-18
    A.3Full title of the trial
    A PHASE 3b CLINICAL STUDY TO ASSESS WHETHER REGULAR ADMINISTRATION OF ADVATE IN THE ABSENCE OF IMMUNOLOGICAL DANGER SIGNALS REDUCES THE INCIDENCE RATE OF INHIBITORS IN PREVIOUSLY UNTREATED PATIENTS WITH HEMOPHILIA A
    ESTUDIO CLÍNICO EN FASE IIIb PARA EVALUAR SI LA ADMINISTRACIÓN REGULAR DE ADVATE EN AUSENCIA DE SEÑALES DE PELIGRO INMUNOLÓGICO REDUCE LA TASA DE INCIDENCIA DE INHIBIDORES EN PACIENTES CON HEMOFILIA A NO TRATADOS PREVIAMENTE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to find out whether regular infusions of ADVATE in the absence of immunological danger signals (eg. tissue damage/viral or bacterial infections) reduces the possibility of inhibitor in PUPs with hemophilia A
    Estudio clínico para determinar si las infusiones regulares de ADVATE en ausencia de señales de peligro inmunológico (por ejemplo, daño a los tejidos / infecciones virales o bacterianas) reduce la posibilidad de inhibidor en PnTP con hemofilia A
    A.3.2Name or abbreviated title of the trial where available
    EARLY PROPHYLAXIS IMMUNOLOGIC CHALLENGE (EPIC) STUDY
    ESTUDIO DE PROVOCACIÓN INMUNOLÓGICA PARA PROFILAXIS PRECOZ
    A.4.1Sponsor's protocol code number061002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBaxter Innovations GmbH
    B.1.3.4CountryAustria
    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 supportBaxter Innovations GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxter Innovations GmbH
    B.5.2Functional name of contact pointJudit Koranyi, MD - ClinOps
    B.5.3 Address:
    B.5.3.1Street AddressWagramer Strasse 17-19
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1221
    B.5.3.4CountryAustria
    B.5.4Telephone number+431201003301
    B.5.5Fax number+43120100534
    B.5.6E-mailisabella_neidhart@baxter.com
    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 ADVATE (rAHF-PFM)
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter AG Austria
    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 nameADVATE (rAHF-PFM)
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 139076-62-3
    D.3.9.4EV Substance CodeSUB16449MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 Yes
    D.2.1.1.1Trade name ADVATE (rAHF-PFM)
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter AG Austria
    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 nameADVATE (rAHF-PFM)
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 139076-62-3
    D.3.9.4EV Substance CodeSUB16449MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    Prevention of inhibitor formation, and immune tolerance induction in patients with severe and moderately severe hemophilia A by early and low-dose prophylactic ADVATE therapy
    Prevención de la formación de inhibidores y de inducción de tolerancia inmunológica en pacientes con hemofilia A grave o moderadamente grave tratados con ADVATE con una pauta profiláctica precoz a baja dosis.
    E.1.1.1Medical condition in easily understood language
    Coagulation Factor VIII deficiency
    Deficiencia de Factor de coagulación VIII
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10060612
    E.1.2Term Hemophilia A
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the incidence rate of inhibitor formation in PUPs with severe and moderately severe hemophilia A during the first 50 exposure days (EDs) to starting with a once weekly prophylactic regimen together with the minimization of immunological danger signals
    Determinar la tasa de incidencia de formación de inhibidores en PnTP con hemofilia A grave y moderadamente grave durante los 50 primeros días de exposición (DE) al tratamiento, empezando por una pauta profiláctica una vez por semana junto con la minimización de señales de peligro inmunológico
    E.2.2Secondary objectives of the trial
    - Determine the general safety and efficacy during the first 50 EDs to ADVATE of an once weekly early prophylactic regimen starting once weekly in PUPs with severe and moderately severe hemophilia A
    - Gather information about the temporal associations and molecular and cellular mechanisms involved in the development of an immune response to factor VIII (FVIII) during the first 50 EDs to ADVATE
    - Determinar la eficacia y seguridad general de una pauta profiláctica precoz una vez por semana en PnTP con hemofilia A grave y moderadamente grave durante los 50 primeros DE a ADVATE.
    - Recopilar información sobre las asociaciones temporales y los mecanismos moleculares y celulares implicados en el desarrollo de una respuesta inmunitaria al factor VIII durante los 50 primeros DE a ADVATE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who meet all of the following criteria are eligible for this study:
    - Subjects with severe and moderately severe hemophilia A (FVIII =< 2%)
    - Certain FVIII mutation types (eg, large multi-domain deletions; nonsense mutations; insertions/deletions/inversions that result in a premature stop codon; intron 22 inversions) can be used to corroborate a severe hemophilia A phenotype when laboratory assays show FVIII levels >=1% because of rounding errors or carryover effect from a previous FVIII administration; a central laboratory FVIII assay is required to confirm subject eligibility.
    - Subjects < 1 year of age.
    - Subjects must have =< 3 EDs to any FVIII concentrate or FVIII-containing product used for treatment of minor bleeds (bleeds requiring no more than 2 infusions per event), or for preventative or precautionary infusions following possible injury.
    - Subjects with prior circumcision are allowed to enroll only if bleeding issues related to circumcision were the cause for the original diagnosis of hemophilia A and if no more than 2 EDs of FVIII were required.
    - Adequate venous access (without need for central venous access device [CVAD]-placement) as determined by the physician
    - Written informed consent from legally authorized representative(s)
    - Pacientes con hemofilia A grave y moderadamente grave (FVIII =< 2%).
    - Determinados tipos de mutaciones del FVIII (como, por ejemplo, grandes deleciones multidominio; mutaciones terminadoras; inserciones/deleciones/inversiones que tienen como resultado un codón de terminación prematura; inversiones del intrón 22) se pueden utilizar para corroborar un fenotipo de hemofilia A grave cuando en las analíticas se evidencian niveles de FVIII >= 1% debido a errores de redondeo o al efecto residual de una administración previa de FVIII; para confirmar que el paciente puede participar en el estudio, los niveles de FVIII se tienen que determinar en el laboratorio central.
    - Pacientes < 1 año de edad.
    - Los pacientes tienen que tener =< 3 DE a cualquier concentrado de FVIII o producto que contenga FVIII empleado para el tratamiento de hemorragias menores (hemorragias para las que se necesita un máximo de 2 infusiones por caso), o a infusiones preventivas o de precaución tras una posible lesión.
    - Se permite participar a pacientes con circuncisión previa sólo si la causa del diagnóstico original de hemofilia A ha sido la aparición de problemas hemorrágicos asociados a la circuncisión y si no han sido necesarios más de 2 DE a tratamiento con FVIII.
    - Acceso venoso adecuado (sin necesidad de colocación de un DAVC) determinado por el médico.
    - Consentimiento informado por escrito del(de los) representante(s) legalmente autorizado(s).
    E.4Principal exclusion criteria
    - Life-threatening conditions (intracranial hemorrhage, severe trauma), or requirement for surgery at the time of enrollment
    - Evidence of inhibitor >= 0.6 BU in Njimegen-modified Bethesda Assay at study start (samples may be retested using lupus-insensitive inhibitor tests to reduce the number of false positive inhibitortesting for lupus anticoagulant will be done to eliminate false positives)
    - Inherited or acquired hemostatic defect other than hemophilia A
    - Any clinically significant, chronic disease other than hemophilia A
    - Known hypersensitivity to ADVATE or any of its constituents
    - Any planned elective surgery that cannot be postponed until after the first 20 EDs
    - Participation in the Hemophilia Inhibitor PUP Study (HIPS)
    - Application of red blood cell, platelet, or leukocyte concentrates, or plasma
    - Administration of any medication affecting coagulation or platelet function
    - Systemic administration of any immunomodulatory drug (eg, chemotherapy, intravenous glucocorticoids)
    - Participation in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or during the course of this study
    - Enfermedades potencialmente mortales (hemorragia intracraneal, traumatismo grave) o necesidad de cirugía en el momento del reclutamiento.
    - Evidencia de nivel de inhibidores >= 0,6 UB en el ensayo Bethesda (método modificado de Nijmegen) al inicio del estudio (las muestras se pueden reanalizar utilizando pruebas de inhibidores insensibles a lupus para reducir el número de resultados falsos positivos).
    - Defecto hemostático hereditario o adquirido distinto de hemofilia A.
    - Cualquier enfermedad crónica clínicamente significativa distinta de hemofilia A.
    - Hipersensibilidad conocida a ADVATE o a cualquiera de sus componentes.
    - Toda intervención quirúrgica programada que no pueda posponerse hasta después de los 20 primeros DE.
    - Participación en el estudio en PnTP de los inhibidores en la hemofilia (Hemophilia Inhibitor PUP Study [HIPS]).
    - Aplicación de concentrados de eritrocitos, plaquetas o leucocitos, o plasma.
    - Administración de cualquier medicamento que altere la coagulación o la función plaquetaria.
    - Administración sistémica de cualquier fármaco inmunomodulador (como, por ejemplo, quimioterapia, glucocorticosteroides intravenosos).
    - La participación en otro estudio clínico de un dispositivo o PEI durante los 30 días anteriores al reclutamiento para participar en este estudio o durante la realización de éste.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of inhibitor formation in severe and moderately severe hemophilia A (FVIII =< 2%) within the first 50 EDs to ADVATE (prior exposure to FVIII up to a maximum of 3 EDs but maximum 2 exposures per event - to any FVIII concentrate are allowed, and infusions for bleed management will be included in the 50-ED calculation)
    - Incidencia de formación de inhibidores en la hemofilia A grave y moderadamente grave (FVIII =< 2%) durante los 50 primeros DE a ADVATE (se permite la exposición anterior a FVIII hasta un máximo de 3 DE, pero un máximo de 2 exposiciones por caso - a cualquier concentrado de FVIII, y en el cálculo de los 50 DE se incluirán las infusiones para el tratamiento de hemorragias)
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of study
    final del ensayo
    E.5.2Secondary end point(s)
    - Incidence of inhibitor formation in severe hemophilia A (FVIII =<1% within the first 50 EDs of ADVATE
    - Time to inhibitor formation
    - Incidence rate for low-titer, high-titer, transient, and all inhibitors
    - Incidence of SAEs and non-serious AEs at least possibly related to ADVATE
    - Number, type, and severity of all bleeds experienced (eg, intracranial hemorrhage, joint, soft tissue)
    - Number, type, and severity of all bleeds experienced when different prophylactic dosing frequencies are used (once per week versus 2-3 times per week)
    - Number and type of surgeries (which cannot be postponed until after 20 EDs)
    - Association of known risk factors to inhibitor formation: FVIII gene mutation type, FVIII haplotype, HLA haplotypes, family history of inhibitors, infections, immunomodulatory gene polymorphisms (tumor necrosis factor-alpha [TNF-alpha], interleukin-10 [IL-10], cytotoxic T-lymphocyte antigen 4 [CTLA4])
    - Total FVIII consumption (in international units [IU]) for each subject
    - FVIII-specific antibody isotype for all subjects at study entry and every 10 ED
    - Incidencia de formación de inhibidores en la hemofilia A grave (FVIII =<1%) durante los 50 primeros DE a ADVATE.
    - Tiempo hasta la formación de inhibidores.
    - Tasa de incidencia de inhibidores de título bajo, de título elevado, transitorios y totales.
    - Incidencia de AAG y AA no graves al menos posiblemente relacionados con ADVATE.
    - Número, tipo y gravedad de todas las hemorragias experimentadas (p. ej., hemorragia intracraneal, hemartrosis, de partes blandas).
    - Número, tipo y gravedad de todas las hemorragias experimentadas en función de la frecuencia de administración del tratamiento profiláctico (una vez por semana en comparación con 2-3 veces por semana).
    - Número y tipo de intervenciones quirúrgicas (que no se pueden posponer hasta después de 20 DE).
    - Asociación de factores de riesgo de formación de inhibidores conocidos: tipo de mutación del gen del FVIII, haplotipo del FVIII, haplotipos HLA, antecedentes familiares de inhibidores, infecciones, polimorfismos de genes inmunomoduladores (factor de necrosis tumoral alfa [TNF-alpha], interleucina 10 [IL-10], antígeno 4 asociado al linfocito T citotóxico [CTLA4]).
    - Consumo total de FVIII (en unidades internacionales [UI]) por cada paciente.
    - Isotipo de los anticuerpos específicos del FVIII de todos los pacientes al inicio del estudio y cada 10 DE.
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of study
    final del ensayo
    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 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 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) 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 No
    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 No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Históricamente controlado
    Historically controlled
    E.8.2.4Number of treatment arms in the trial1
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Bulgaria
    Canada
    Denmark
    France
    Germany
    Greece
    Ireland
    Italy
    Latvia
    Lithuania
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    Spain
    Sweden
    Switzerland
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    Last subject / last visit
    Último sujeto / última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 100
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 2
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 2
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 96
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects < 1 year of age.
    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 88
    F.4.2.2In the whole clinical trial 100
    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)
    not different from the expected normal treatment of hemophilia A
    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 Decision2012-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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