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    Summary
    EudraCT Number:2010-024108-84
    Sponsor's Protocol Code Number:071001
    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:2012-04-02
    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 number2010-024108-84
    A.3Full title of the trial
    A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OF BLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRAND DISEASE
    ESTUDIO CLÍNICO DE FASE 3 PARA DETERMINAR LA FARMACOCINÉTICA, SEGURIDAD Y EFICACIA DE rVWF:rFVIII y DE rVWF EN EL TRATAMIENTO DE EPISODIOS HEMORRÁGICOS EN SUJETOS CON DIAGNÓSTICO DE ENFERMEDAD DE VON WILLEBRAND
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to explore the influence of the human body on the study drug, on the safety and efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.
    Estudio clínico para valorar la influencia del organismo en el fármaco de estudio, en la seguridad y eficacia del factor VW recombinante (en combinación con el factor VIII recombinante y del Factor VW solo) en el tratamiento de hemorragias en pacientes con enfermedad de Von Willebrand
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetics, safety and efficacy of rVWF in the treatment of bleeding episodes in VWD
    Farmacocinética, seguridad y eficacia de rVWF en el tratamiento de episodios hemorrágicos en la EvW
    A.4.1Sponsor's protocol code number071001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01410227
    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 pointDr. Guido Wuerth, Director ClinOps
    B.5.3 Address:
    B.5.3.1Street AddressWagramer Strasse 17 - 19
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1220
    B.5.3.4CountryAustria
    B.5.4Telephone number+431201003489
    B.5.5Fax number+43120100717
    B.5.6E-mailguido_wuerth@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 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/3/10/814
    D.3 Description of the IMP
    D.3.1Product namerVWF
    D.3.2Product code BAX111
    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 INNvonicog alfa
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number650
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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
    Von Willebrand Disease
    Enfermedad de Von Willebrand
    E.1.1.1Medical condition in easily understood language
    Hereditary deficiency of Von Willebrand Factor in blood.
    Enfermedad de Von Willebrand hereditaria en sangre
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10047715
    E.1.2Term Von Willebrand's disease
    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
    Assessment of pharmacokinetics (PK) of rVWF:rFVIII and rVWF
    andassessment of safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary VWD.
    Evaluar la farmacocinética (FC) de rVWF:rFVIII y de rVWF, y evaluar la seguridad y la eficacia de rVWF:rFVIII y de rVWF en el tratamiento de los episodios hemorrágicos en sujetos con EvW severa hereditaria
    E.2.2Secondary objectives of the trial
    - Compare PK parameters of rVWF alone or in combination with rFVIII in subjects with type 3 VWD
    - Examine PK parameters of rVWF in subjects with severe VWD or type 2N VWD
    - Evaluate hemostatic efficacy, safety, and tolerability of rVWF:rFVIII and rVWF in subjects with VWD receiving the investigational product for treatment of bleeding episodes
    - Evaluate tolerability and safety of rVWF including the development of inhibitory and total binding anti-VWF antibodies and clinically significant changes in laboratory parameters following drug administration
    - Assess changes in health-related quality of life (HRQoL)
    - Comparar los parámetros FC de rVWF solo o en combinación con rFVIII en sujetos con EvW tipo 3
    - Examinar los parámetros FC de rVWF en sujetos con EvW severa o con EvW tipo 2N
    - Evaluar la eficacia hemostática, seguridad y tolerabilidad de rVWF:rFVIII y de rVWF en sujetos con EvW que reciben el producto en investigación para el tratamiento de episodios hemorrágicos
    - Evaluar la tolerabilidad y seguridad de rVWF, incluido el desarrollo de anticuerpos anti-VWF inhibidores y de unión total, y los cambios clínicamente significativos en los parámetros analíticos después de la administración del fármaco
    - Evaluar los cambios en la calidad de vida relacionada con la salud
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject has been diagnosed with: type 3 (VWD:Ag ?3 IU/dl) or severe non-type 3 VWD (VWF:RCo <20 IU/dL) or type 2N VWD (FVIII:C <10% and historically documented genetics)
    ? Subject, who participates for the treatment for bleeding episodes, has had a minimum of 6 documented bleeds (medical history) requiring VWF coagulation factor replacement therapy during the previous 3 years prior to enrollment.
    ? Subject has a Karnofsky score ?60.
    ? Subject is at least 18 and not older than 65 years of age at enrollment.
    ? If female of childbearing potential, subject presents with a negative serum pregnancy test.
    ? Subject agrees to employ adequate birth control measures for the
    duration of the study.
    ? Subject is willing and able to comply with the requirements of the
    protocol.
    - El sujeto tiene un diagnóstico de:-EvW tipo 3 (VWF:Ag ?3 UI/dl) o EvW tipo no 3 severa (VWF:RCo <20 UI/dl) o EvW tipo 2N (FVIII:C <10 % y genética históricamente documentada)
    - El sujeto que participe en el tratamiento de los episodios hemorrágicos ha tenido un mínimo de 6 hemorragias documentadas (historia clínica) que hayan precisado tratamiento de reposición del factor de coagulación VWF durante los 3 años previos a la inclusión.
    - El sujeto tiene una puntuación Karnofsky ?60.
    - El sujeto tiene al menos 18 y no más de 65 años de edad en el momento de la inclusión.
    - Las mujeres en edad fértil tienen una prueba de embarazo negativa
    - El sujeto acepta utilizar métodos anticonceptivos adecuados durante el estudio.
    - El sujeto tiene voluntad y capacidad para cumplir todos los aspectos del protocolo
    E.4Principal exclusion criteria
    ? Subject has been diagnosed with pseudo VWD or another hereditary or acquired coagulation disorder other than VWD (eg qualitative and quantitative platelet disorders or elevated PT/ international normalized ratio [INR] >1.4).
    ? Subject has a documented history of a VWF:RCo half-life of <6 hours.
    ? Subject has a history or presence of a VWF inhibitor at screening.
    ? Subject has a history or presence of a factor VIII (FVIII) inhibitor with a titer ?0.4 BU (by Nijmegen assay) or ?0.6 BU (by Bethesda assay).
    ? Subject has a known hypersensitivity to any of the components of the study drugs, such as to mouse or hamster proteins.
    ? Subject has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies.
    ? Subject has a medical history of a thromboembolic event.
    ? Subject is HIV positive with an absolute CD4 count <200/mm3.
    ? Subject has been diagnosed with cardiovascular disease (New York
    Heart Association [NYHA] classes 1-4).
    ? Subject has an acute illness (eg, influenza, flu-like syndrome, allergic rhinitis/conjunctivitis, non-seasonal asthma) at screening.
    ? Subject has been diagnosed with significant liver disease as evidenced by any of the following: serum alanine aminotransferase (ALT) 5 times the upper limit of normal; hypoalbuminemia; portal vein hypertension (eg, presence of otherwise unexplained splenomegaly, history of esophageal varices).
    ? Subject has been diagnosed with renal disease, with a serum
    creatinine level ?2 mg/dL.
    ? In the judgment of the investigator, subject has another clinically
    significant concomitant disease (eg, uncontrolled hypertension) that
    may pose additional risks for the subject.
    ? Subject has been treated with an immunomodulatory drug, excluding topical treatment (eg, ointments, nasal sprays), within 30 days prior to signing the informed consent.
    ? Subject is pregnant or lactating at the time of enrollment.
    ? Subject has participated in another clinical study involving an IP or
    investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product or investigational device during the course of this study.
    ? Subject has a history of drug or alcohol abuse within the 2 years prior to enrollment.
    ? Subject has a progressive fatal disease and/or life expectancy of less than 3 months.
    ? Subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.
    ? Subject suffers from a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
    ? Subject is in prison or compulsory detention by regulatory and/or
    juridical order.
    -El sujeto tiene un diagnóstico de pseudo EvW o cualquier otro trastorno de la coagulación hereditario o adquirido distinto de la VWD (trastornos plaquetarios cualitativos y cuantitativos o TP elevado/cociente internacional normalizado [INR] >1,4).
    -El sujeto tiene antecedentes documentados de una semivida de VWF:RCo <6 horas
    -El sujeto tiene antecedentes o presencia de un inhibidor de VWF en la selección.
    -El sujeto tiene antecedentes o presencia de un inhibidor del factor VIII (FVIII) con un título UB ?0,4 (según el ensayo de Nijmegen) o UB ?0,6 (según el ensayo de Bethesda).
    - El sujeto tiene hipersensibilidad conocida a cualquiera de los componentes de los fármacos del estudio, como las proteínas de ratón o de hámster.
    - El sujeto tiene antecedentes de trastornos inmunológicos, excluida la rinitis/conjuntivitis estacional alérgica, el asma, las alergias alimentarias o las alergias animales.
    - El sujeto tiene antecedentes de un episodio tromboembólico.
    - El sujeto es positivo para el VIH con un recuento absoluto de CD4 <200/mm3.
    - El sujeto tiene un diagnóstico de enfermedad cardiovascular (NY H Ass (HYHA) de las clases 1-4).
    -El sujeto tiene una enfermedad aguda (p.ej, gripe, síndrome pseudogripal, rinitis/conjuntivitis alérgica, asma no estacional) en la selección.
    -El sujeto tiene un diagnóstico de hepatopatía significativa demostrada por cualquiera de los elementos siguientes: alanina aminotransferasa (ALT) 5 x límite superior de la normalidad; hipoalbuminemia; hipertensión de la vena portal (p.ej. presencia de esplenomegalia i
    nexplicada, antecedentes de varices esofágicas).
    - El sujeto tiene un diagnóstico de nefropatía, con una concentración de creatinina sérica ?2 mg/dl.
    - En opinión del investigador, el sujeto tiene otra enfermedad concomitante clínicamente significativa (p ej, hipertensión no controlada) que puede suponerle riesgos adicionales.
    - El sujeto ha sido tratado con un fármaco inmunomodulador, excluido el tratamiento tópico (p ej, pomadas, pulverizadores nasales), en los 30 días previos a la firma del consentimiento informado.
    - La paciente está embarazada o en período de lactancia en el momento de la inclusión.
    -El sujeto ha participado en otro ensayo clínico con un PEI en los 30 días previos
    a la inclusión o tiene previsto participar en otro estudio clínico con un PEI durante este estudio.
    -El sujeto tiene antecedentes de abuso de alcohol o de sustancias en los 2 años anteriores a la inclusión.
    -El sujeto tiene una enfermedad progresiva mortal y una esperanza de vida menor de 3 meses
    -El sujeto es considerado por el inv. incapaz o no dispuesto a cooperar con los
    rocedimientos del estudio.
    -El sujeto padece un trastorno mental que le hace incapaz de comprender la natura, alcance y posibles consecuencias del estudio o exiten pruebas de actitud no cooperadora.
    - El sujeto está en prisión o internado en una institución por resolución administrativa o judicial.
    E.5 End points
    E.5.1Primary end point(s)
    Number of subjects with treatment success for treated bleeding episodes.
    Número de sujetos con éxito del tratamiento en los episodios hemorrágicos tratados.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall clinical efficacy rating within 24 hrs of resolution of bleed by investigator. Home treatments will be evaluated at each study visit. Analysis of efficacy will be performed after each study part.
    Eficacia clínica total valorada por el investigador dentro de las 24 horas tras la resolución de la hemorragia. Los tratamientos domiciliarios serán evaluados en cada una de las visitas. El análisis de la eficacia se realizará después de cada una de las etapas del estudio.
    E.5.2Secondary end point(s)
    1) Efficacy
    ? Number of treated bleeding episodes with an efficacy rating of
    'excellent' or 'good'
    ? Number of infusions and rVWF:rFVIII and/or rVWF units per bleeding episode
    2) Safety
    ? Development of inhibitory and total binding anti-VWF antibodies
    ? Development of inhibitory antibodies to FVIII
    ? Development of antibodies to Chinese hamster ovary (CHO) proteins,mouse immunoglobulin G (IgG) and rFurin
    ? Occurrence of thrombotic events
    ? Other IP related AEs, such as clinically significant changes in routine laboratory parameters (hematology and clinical chemistry) and vital signs
    3) Pharmacokinetic
    ? Area under the plasma concentration/time curve from time 0 to
    infinity (AUC0-?/Dose); area under the plasma concentration/time
    curve from time 0 to 96 hours (AUC0-96h/Dose); mean residence time (MRT); clearance (CL); incremental recovery (IR), elimination phase half-life (T1/2); volume of distribution at steady state (Vss) of VWF Ristocetin cofactor (VWF:RCo), VWF antigen (VWF:Ag), VWF
    collagenbinding(VWF:CB), and FVIII.
    ? In vivo recovery (IVR) of VWF:RCo, VWF:Ag and VWF:CB.
    ? Comparison of intra-subject PK of VWF:RCo, VWF:CB and VWF:Ag at baseline and after 6 months in a subset of at least 20 subjects with severe VWD (minimum 6 subjects with type 3 VWD)
    4) Exploratory Endpoints
    ? Generic: Physical Component Score (PCS) and Mental Component Score
    (MCS) of the Short Form-36 (SF-36)
    ? Disease-specific: Total score of the unvalidated von Willebrand Disease Impact Questionnaire
    Eficacia:
    - Nº de episodios hemorrágicos tratados con resultado terapéutico ?excelente? o ?bueno?.
    - Nº de infusiones y de unidades de rVWF:rFVIII o rVWF por episodio hemorrágico
    Seguridad:
    - Desarrollo de anticuerpos anti-VWF inhibidores y de unión total
    - Desarrollo de anticuerpos inhibidores contra FVIII
    - Desarrollo de anticuerpos contra las proteínas de ovario de hámster chino (CHO), la inmunoglobulina G (IgG) de ratón y la r-furina
    - Aparición de episodios trombóticos
    - Otros AAs relacionados con el PEI, como alteraciones clínicamente importantes en los parámetros analíticos habituales (hematología y bioquímica clínica) y en las constantes vitales
    Farmacocinética:
    - AUC de concentración plasmática/tiempo desde el tiempo 0 hasta el infinito (AUC0-?/dosis), AUC de concentración plasmática/tiempo desde el tiempo 0 hasta las 96 horas (AUC0-96h/dosis); tiempo medio de permanencia (TMP); aclaramiento (CL); recuperación incremental (RI), semivida de la fase de eliminación (T1/2); volumen de distribución en estado de equilibrio (Vss) del cofactor de ristocetina como actividad del factor de vonWillebrand (VWF:RCo), antígeno de VWF (VWF:Ag), unión de VWF a colágeno (VWF:CB) y FVIII.
    - Recuperación in vivo (RIV) de VWF:RCo, VWF:Ag y VWF:CB.
    - Comparación de la FC intrasujeto de VWF:RCo, VWF:CB y VWF:Ag en el período basal y después de 6 meses en un subgrupo de al menos 20 sujetos con EvW severa (mínimo de 6 sujetos con EvW tipo 3).
    Criterios de valoración exploratorios:
    Se utilizarán como criterios de valoración exploratorios deos instrumentos para medir la calidad de vida relacionada con la salud (CdVRS):
    - Genérico: Puntuación de los componentes de salud física (PCS) y de los componentes de salud mental (MCS) del Cuestionario abreviado Short Form-36 (SF-36)
    - Específico de la enfermedad: puntuación total del Cuestionario de impacto de la EvW no validado
    r
    elacionada con la salud (CdVRS):
    E.5.2.1Timepoint(s) of evaluation of this end point
    After each study study part.
    después de cada una de las etapas del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.2Open No
    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
    Abierto, salvo el grupo de análisis FC 50 (simple ciego)
    Open-label, except for PK50 arm (single blinded)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA35
    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
    Australia
    Austria
    Belgium
    Bulgaria
    Canada
    France
    Germany
    India
    Italy
    Japan
    Netherlands
    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
    LVLS
    Última visita y último paciente
    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 months0
    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 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 No
    F.1.1Number of subjects for this age range: 0
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 40
    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)
    After the end of the clinical trial, the patients will receive the required standard therapy, as assessed by their treating physician
    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 Decision2012-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-15
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