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    Summary
    EudraCT Number:2010-021781-29
    Sponsor's Protocol Code Number:BAY81-8973/13400
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2014-02-27
    Trial 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 number2010-021781-29
    A.3Full title of the trial
    A multicenter Phase III uncontrolled open-label trial to evaluate safety and efficacy of BAY 81-8973 in children with severe haemophilia A under prophylaxis therapy
    Estudio de fase III, multicéntrico, abierto y no controlado para evaluar la seguridad y la eficacia de BAY 81-8973 en niños con hemofilia A grave en tratamiento profiláctico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter Phase III uncontrolled open-label trial to evaluate safety and efficacy of BAY 81-8973 in children with severe haemophilia A under prophylaxis therapy
    Estudio de fase III, multicéntrico, abierto y no controlado para evaluar la seguridad y la eficacia de BAY 81-8973 en niños con hemofilia A grave en tratamiento profiláctico
    A.3.2Name or abbreviated title of the trial where available
    Leopold Kids
    A.4.1Sponsor's protocol code numberBAY81-8973/13400
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/259/2013
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointCTP Team / Ref: "EU CTR" /
    B.5.3 Address:
    B.5.3.1Street AddressS201, Level 2, Room 156
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number0034.900102372
    B.5.5Fax number-------------
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 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 81-8973 (250 IU/vial)
    D.3.2Product code BAY 81-8973
    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 -
    D.3.9.2Current sponsor codeBAY 81-8973
    D.3.9.3Other descriptive namerecombinant coagulation factor VIII
    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 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 81-8973 (500 IU/vial)
    D.3.2Product code BAY 81-8973
    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 -
    D.3.9.2Current sponsor codeBAY 81-8973
    D.3.9.3Other descriptive namerecombinant coagulation factor VIII
    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.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBAY 81-8973 (1000 IU/vial)
    D.3.2Product code BAY 81-8973
    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 -
    D.3.9.2Current sponsor codeBAY 81-8973
    D.3.9.3Other descriptive namerecombinant coagulation factor VIII
    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) 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
    Severe Hemophilia-A (< 1% FVIII:C)
    Hemofilia A grave, definida como una FVIII:C < 1 %,
    E.1.1.1Medical condition in easily understood language
    Hemophilia A is an X-linked congenital bleeding disorder causing frequent bleedings and recurrent spontaneous bleeds into the soft tissue and joints, leading to joint damage and severe disability.
    La hemofilia A es un trastorno hemorrágico hereditario ligado al cromosoma X que afecta a tejidos blandos y articulaciones, provocando daño articular y discapacidad grave.
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10060612
    E.1.2Term Hemophilia A
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the safety and efficacy of the treatment with BAY 81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe hemophilia A.
    El objetivo principal es evaluar la seguridad y la eficacia del tratamiento con BAY 81-8973 para la profilaxis y el tratamiento de las hemorragias intercurrentes en niños con hemofilia A grave
    E.2.2Secondary objectives of the trial
    The secondary objectives are
    - To assess the safety and efficacy of BAY 81-8973 during surgeries.
    - To assess incremental recovery of BAY 81-8973.
    - To assess pharmacokinetic parameters in a subset of children.
    Los objetivos secundarios son:
    - Evaluar la seguridad y la eficacia de BAY 81-8973 durante intervenciones quirúrgicas.
    - Evaluar la recuperación incremental de BAY 81-8973.
    - Evaluar los parámetros farmacocinéticos en un subconjunto de niños.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A
    1. Male, age <= 12 years. Enrollment will begin with subjects 6-12 years before it is opened to all age groups.
    2. Severe hemophilia A defined as < 1% factor VIII concentration (FVIII:C) based on documented prior testing or screening laboratory
    3. >/= 50 ED with any FVIII concentrate
    4. No current evidence of inhibitor antibody measured using the Nijmegen modified Bethesda assay [<0.6 Bethesda units (BU)/mL] within 2-3 weeks of last FVIII administration.
    5. No history of FVIII inhibitor formation. Documentation of negative result in medical records required. [Subjects with a maximum historical titer of 1.0 BU on no more than 1 occasion with the classical Bethesda assay but at least 3 successive negative (<0.6 BU) results thereafter are eligible.]
    6. Willingness and ability of subjects and/or parents to complete training in the use of the electronic patient diary (EPD) and to document infusions during the study.
    7. Written informed consent by parent/legal representative. Assent should be sought from subjects if appropriate

    Part B (PUPs)
    1. Male, < 6 years
    2. Severe hemophilia A defined as < 1% FVIII:C based on prior documented testing or confirmed on screening laboratory
    3. No previous exposure to any FVIII product
    4. PUPs may be included if they will receive their first FVIII dose with BAY 81-8973 for treatment of first bleeds and agree to start prophylaxis as part of their care.
    5. Willingness and ability of parents to complete training in the use of the electronic patient diary (EPD) and to document all treatment during the study.
    6. Written informed consent by parent/legal representative.
    Parte A:
    1. Pacientes varones <= 12 años de edad. La inclusión de pacientes de 6 - 12 años de edad precederá a la de todos los demás grupos de edad.
    2. Hemofilia A grave, definida como una concentración de factor VIII (FVIII:C) < 1 %, documentada a partir de un análisis previo o en las pruebas analíticas de selección
    3. >/= 50 DE con cualquier concentrado de FVIII
    4. Ausencia de anticuerpos inhibidores determinada mediante el ensayo de Bethesda modificado por Nijmegen [< 0,6 unidades Bethesda (UB)/ml] realizado en las 2 - 3 semanas posteriores a la última administración de FVIII.
    5. Sin antecedentes de formación de inhibidores del FVIII. Es necesario un resultado negativo documentado en la historia clínica. [Puede incluirse también a los pacientes con un valor histórico máximo de 1,0 UB en el ensayo de Bethesda clásico obtenido como máximo en una única ocasión, pero por lo menos con 3 resultados negativos sucesivos (< 0,6 UB) posteriores]
    6. Disposición y capacidad de los pacientes y/o sus progenitores para completar la formación sobre el uso del diario electrónico del paciente (DEP) y anotar las infusiones durante el estudio.
    7. Consentimiento informado por escrito firmado por uno de los progenitores/representante legal. Asentimiento de los pacientes, si procede.

    Parte B (PNTP)
    1. Varón, < 6 años
    2. Hemofilia A grave, definida como una FVIII:C < 1 %, documentada a partir de un análisis previo o confirmada en las pruebas analíticas de selección.
    3. Sin exposición previa a ningún producto de FVIII
    4. Puede incluirse a PNTP si van a recibir su primera dosis de FVIII con BAY 81-8973 para el tratamiento de las primeras hemorragias y acceden a iniciar la profilaxis como parte de su tratamiento.
    5. Disposición y capacidad de los progenitores para completar la formación sobre el uso de diario electrónico del paciente (DEP) y anotar todos los tratamientos durante el estudio.
    6. Consentimiento informado por escrito por uno de los progenitores/representante legal.
    E.4Principal exclusion criteria
    Parts A and B
    1. Any individual with another bleeding disorder that is different from Hemophilia A (eg, von Willebrand disease, Hemophilia B)
    2. Any individual with thrombocytopenia (platelet count < 100,000/mm3)
    3. Creatinine > 2x upper limit of normal or AST/ALT > 5x upper limit of normal
    4. Any individual without a negative inhibitor at screening (except for PUPs)
    5. Any individual who is receiving chemotherapy, immune modulatory drugs (IVIG, cyclosporine, chronic use of oral or i.v. corticosteroids), has received another investigational FVIII product within the last month, or received another experimental drug within the last 3 months.
    6. Any individual who requires any pre-medication to tolerate FVIII treatment (eg, antihistamines).
    7. Any individual who is unwilling to comply with study visits or other protocol requirements, for example (eg. prophylaxis treatment) or is not suitable for participation in this study for any reason, according to the Investigator's judgment.
    8. Known hypersensitivity to active substance, mouse or hamster protein.
    9. Previous participation in this study

    Part B only (PUPs):
    10. First treatment with BAY 81-8973 for high risk bleeding situations (e.g. surgery, intracranial bleed), or requiring intensive or prolonged treatment.
    11. Unable to tolerate volume of blood draws required for study participation.
    Partes A y B:
    1. Presencia de otro trastorno hemorrágico (a partir de la Enm. 1) diferente de la hemofilia A (p. ej., enfermedad de von Willebrand, hemofilia B)
    2. Trombocitopenia (cifra de plaquetas < 100 000/mm3)
    3. Niveles de creatinina > 2 veces por encima del límite superior de la normalidad o niveles de aspartato-aminotransferasa (AST)/alanina-aminotransferasa (ALT) > 5 veces el límite superior de la normalidad (a partir de la Enm. 1)
    4. No disponer de una prueba de inhibidores negativa en la selección (salvo para los PNTP)
    5. Tratamiento actual con quimioterapia, fármacos inmunomoduladores (inmunoglobulina intravenosa [IgIV], ciclosporina, uso crónico de corticosteroides por vía oral o i.v.), tratamiento con otro producto de FVIII en investigación durante el último mes o tratamiento con otro fármaco experimental en los últimos 3 meses.
    6. Necesidad de medicación previa para tolerar el tratamiento con FVIII (p. ej., antihistamínicos).
    7. No estar dispuesto a cumplir las visitas del estudio o los demás requisitos del protocolo (p. ej., tratamiento profiláctico) o no ser apto para participar en este estudio por cualquier motivo, según el criterio del investigador
    8. Hipersensibilidad conocida al principio activo o a las proteínas de ratón o hámster.
    9. Participación previa en este estudio.

    Solo para la Parte B (PNTP):
    10. Primer tratamiento con BAY 81-8973 para situaciones de alto riesgo de hemorragia (p. ej., intervención quirúrgica, hemorragia intracraneal), o que requieran un tratamiento intensivo o prolongado.
    11. Incapacidad para tolerar volumen de las extracciones de muestras de sangre necesarias para la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable is the annualized number of total bleeds (sum of spontaneous bleeds and traumatic bleeds) during prophylaxis that occur within 48 h of the last prophylaxis infusion. Both joint and non-joint bleeding will be assessed.
    La variable principal de eficacia será el número anualizado del total de hemorragias intercurrentes (suma de las hemorragias espontáneas y las hemorragias por traumatismo) que se hayan producido en el plazo de 48 horas después de la última infusión profiláctica. Se evaluarán las hemorragias articulares y las no articulares.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuous throughout duration of study
    Continua a lo largo de la duración del estudio
    E.5.2Secondary end point(s)
    - Subject/parents' assessment of the response of treatment of bleeding events which is assessed as excellent, good, moderately well or poorly.
    - Annualized number of total bleeds (sum of spontaneous and trauma bleeds) during prophylaxis treatment
    - Assessment of adequacy of haemostasis during surgical interventions
    - Number of infusions for the treatment of a bleed
    - Consumption of FVIII
    - Evaluación por el paciente o sus progenitores de la respuesta al tratamiento de los episodios hemorrágicos, que se calificará como excelente, buena, moderada o mala.
    - Número anualizado de hemorragias totales (suma de hemorragias espontáneas y hemorragias por traumatismos) durante el tratamiento profiláctico.
    - Evaluación de la eficacia de la hemostasia durante las intervenciones quirúrgicas.
    - Número de infusiones realizadas para el tratamiento de una hemorragia.
    - Consumo de FVIII.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuous throughout duration of study
    Continua a lo largo de la duración del estudio
    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 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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Argentina
    Austria
    Bulgaria
    Canada
    Denmark
    Hungary
    Ireland
    Israel
    Italy
    Latvia
    Lithuania
    Mexico
    Poland
    Romania
    Russian Federation
    Spain
    Sweden
    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
    End of the trial is the last visit (follow-up phone call 1-2 weeks after end of treatment) of the last subject undergoing study.
    El final del estudio es la última visita (Llamada telefónica de seguimiento 1 - 2 semanas después de la finalización del tratamiento) del último paciente del estudio.
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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: 75
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 10
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 15
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    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
    children
    niños
    F.3.3.7Others No
    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 50
    F.4.2.2In the whole clinical trial 75
    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)
    A follow-up extension study until medication is available on market will be offered to all study participants after the end of the main trial
    Al final del estudio principal se ofrecerá a los pacientes participar en un estudio de extensión opcional para continuar el tratamiento con BAY 81-8973 hasta que el fármaco reciba la autorización de comercialización.
    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 Decision2014-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-03
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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