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    EudraCT Number:2012-003176-39
    Sponsor's Protocol Code Number:205MS303
    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:2013-03-21
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-003176-39
    A.3Full title of the trial
    A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301
    Estudio de extensión, abierto, multicéntrico para evaluar la eficacia y la seguridad a largo plazo de BIIB019, Daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP), como monoterapia en sujetos con esclerosis múltiple que hayan completado el estudio 205MS301
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301
    Estudio de extensión de Daclizumba HYP para sujetos con esclerosis múltiple que hayan completado el estudio 205MS301
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number205MS303
    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 SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointEXTEND Clinical Trials Team
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL64AY
    B.5.3.4CountryUnited Kingdom
    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 nameDACLIZUMAB HYP
    D.3.2Product code BIIB019
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDaclizumab
    D.3.9.2Current sponsor codeBIIB019
    D.3.9.3Other descriptive nameDaclizumab HYP (DAC HYP)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Relapsing-remitting Multiple Sclerosis
    Esclerosis múltiple remitente-recidivante
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Esclerosis múltiple
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess the safety and tolerability of long-term treatment with DAC HYP monotherapy in subjects who completed Study 205MS301.
    El objetivo principal de este estudio es evaluar la seguridad y la tolerabilidad del tratamiento a largo plazo con DAC HYP en monoterapia en sujetos que completaron el estudio 205MS301.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are as follows:

    - To assess the long-term immunogenicity of DAC HYP administered by PFS

    - To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and patient-reported impact of MS, following long-term treatment with DAC HYP

    - To assess the safety, tolerability, and efficacy of switching to DAC HYP in subjects previously on long-term treatment with interferon beta 1a in Study 205MS301

    - To evaluate PD parameters that may be associated with treatment response
    Los objetivos secundarios de este estudio en esta población del estudio son los siguientes:

    - Evaluar la inmunogenicidad a largo plazo de DAC HYP administrado con una JPC

    - Describir los resultados relacionados con la EM, incluyendo la recaída de EM, la progresión de la discapacidad, la formación de lesiones de EM y el impacto de la EM notificado por el paciente, tras el tratamiento a largo plazo con DAC HYP

    - Evaluar la seguridad, tolerabilidad y eficacia del cambio farmacológico a DAC HYP en sujetos que previamente seguían el tratamiento a largo plazo con interferón beta-1a en el estudio 205MS301

    - Evaluar los parámetros FD que se puedan asociar con la respuesta al tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
    2. Must be a subject currently participating in Study 205MS301 who has completed either the Week 144 Visit or the End of Study Visit (Week 96).
    Note: Subjects who are not able to enroll into 205MS303 at the time of their Week 144/End of Study Visit may be eligible to enroll into 205MS303 at a later time if they are still participating in the 6-month follow-up period of 205MS301 at the time of expected rollover into 205MS303.
    3. Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
    1. Capacidad de comprender el objetivo y los riesgos del estudio y de dar el consentimiento informado, firmando y fechando el documento correspondiente, así como de autorizar la utilización de información sanitaria protegida (ISP) conforme a la legislación nacional y local de confidencialidad de los datos del sujeto.
    2. Debe ser un sujeto que esté participando actualmente en el estudio 205MS301 que haya completado o bien la visita de la semana 144 o bien la visita de fin del estudio (semana 96).
    Nota: los sujetos que no puedan inscribirse en el 205MS303 en su semana 144/visita de fin del estudio es posible que sean aptos para inscribirse en el 205MS303 más adelante si todavía participan en el período de seguimiento de 6 meses del 205MS301 en el momento previsto para la continuación en el 205MS303.
    3. Las mujeres con capacidad de procrear deben utilizar un método anticonceptivo eficaz durante el estudio y estar dispuestas y ser capaces de continuar su uso durante 4 meses después de la administración de su última dosis del tratamiento del estudio.
    E.4Principal exclusion criteria
    Medical History
    1. Any subject who permanently discontinued study treatment in Study 205MS301 prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS301.
    Note: Subjects for whom dosing was temporarily suspended in Study 205MS301 are not excluded from participation in this extension study if the criteria for resuming DAC HYP treatment under the Study 205MS301 protocol have been met at the time of enrollment into Study 205MS303.
    2. Any significant change in the subject's medical history that would preclude administration of DAC HYP, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in Study 205MS301. The Investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in Study 205MS303, including:
    - History of any significant cardiac, endocrine, hematological, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological (other than MS), and/or other major disease (e.g., malignancy) that would preclude administration of DAC HYP.
    - Clinically significant laboratory abnormalities (hematology and blood chemistry) from the most recently available test in Study 205MS301, as determined by the Investigator. Laboratory findings mandating discontinuation of study treatment as defined in Protocol 205MS301 are exclusionary.
    3. Any of the following abnormal blood tests within the 7 days prior to Day 1:
    - alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase (GGT) >3x the upper limit of normal (ULN)
    Note: Subjects ending 205MS301 on a treatment suspension may not enroll into 205MS303 until ALT/SGPT and AST/SGOT are =<2x ULN.
    - total bilirubin >2x ULN (subjects with an established diagnosis of Gilbert's syndrome are excluded if total bilirubin is >2.5x ULN)
    Note: Subjects ending 205MS301 on a treatment suspension may not enroll into 205MS303 until total bilirubin =<1x ULN (subjects with an established diagnosis of Gilbert's syndrome may not enroll into 205MS303 until total bilirubin is =<1.5x ULN).
    4. Other medical reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment.
    Treatment History
    5. Treatment with any prohibited concomitant medication during Study 205MS301.
    Note: Subjects who start an approved, open-label IFN beta preparation after completion of dosing in Study 205MS301 are not excluded, but IFN beta treatment must be discontinued before the first dose of DAC HYP in Study 205MS303 is given.
    6. Female subjects who are currently pregnant or breastfeeding, or considering becoming pregnant while in the study.
    7. Previous participation in Study 205MS303.
    8. History of drug or alcohol abuse (as defined by the Investigator) at any time after the start of Study 205MS301.
    9. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
    1. Cualquier sujeto que interrumpió permanentemente el tratamiento del estudio 205MS301 antes del fin del periodo de tratamiento o hizo una visita de finalización anticipada en el estudio 205MS301.
    Nota: los sujetos para los que se suspendió temporalmente la dosis en el estudio 205MS301 no quedan excluidos de la participación en este estudio de extensión si los criterios para retomar el tratamiento con DAC HYP conforme al protocolo del estudio 205MS301 se han cumplido en el momento de inscripción en el estudio 205MS303.
    2. Cualquier cambio significativo en la anamnesis del sujeto que impediría la administración de DAC HYP, como las pruebas de laboratorio o una afección actual clínicamente significativa que, en la opinión del investigador, habría excluido al sujeto del estudio 205MS301. El investigador debe comprobar de nuevo si el sujeto es médicamente apto para participar en el estudio y considerar cualquier factor que podría impedir el tratamiento en el estudio 205MS303, como:
    - Antecedentes de cualquier enfermedad significativa cardíaca, endocrina, hematológica, hepática, inmunológica, metabólica, urológica, pulmonar,
    gastrointestinal, dermatológica, psiquiátrica, renal, neurológica (que no sea EM) y/o otras enfermedades importantes (p. ej., cáncer), que impedirían la administración de DAC HYP.
    - Resultados anormales de las pruebas de laboratorio (hematología y bioquímica sanguínea) observadas en el análisis más reciente del que se disponga, realizado en el estudio 205MS301, conforme al criterio del investigador. Los hallazgos de laboratorio para los que es obligatorio interrumpir el tratamiento del estudio que se definen en el protocolo 205MS301 son excluyentes.
    3. Cualquiera de los siguientes resultados anómalos en los análisis de sangre en el plazo de los 7 días antes del día 1:
    - Alanina aminotransferasa/transaminasa sérica glutámico pirúvica (ALT/SGPT), aspartato aminotransferasa/transaminasa sérica glutámico oxalacética (AST/SGOT), ogamma-glutamil transferasa (GGT) > 3x el límite superior de la normalidad (LSN)
    Nota: los sujetos que terminen el 205MS301 por una suspensión del tratamiento no podrán inscribirse en el 205MS303 hasta que el valor de ALT/SGPT y AST/SGOT sean =< 2x LSN.
    - Bilirrubina total > 2x LSN (los sujetos con un diagnóstico definitivo de síndrome de Gilbert quedan excluidos si la bilirrubina total es > 2,5x LSN).
    Nota: los sujetos que terminen el 205MS301 en una suspensión del tratamiento no podrán inscribirse en el 205MS303 hasta que la bilirrubina total sea =< 1x LSN (los sujetos con un diagnóstico definitivo de síndrome de Gilbert no podrán inscribirse en el 205MS303 hasta que la bilirrubina total sea =< 1,5x LSN).
    4. Cualquier otro motivo médico que, en opinión del investigador y/o de Biogen Idec, haga al sujeto no apto para su inscripción.
    Historial de tratamiento
    5. El tratamiento con cualquier medicamento concomitante prohibido durante el estudio 205MS301.
    Nota: los sujetos que comiencen una preparación de IFN beta abierta y aprobada tras completar la administración del estudio 205MS301 no quedan excluidos, aunque el tratamiento con IFN beta debe interrumpirse antes de la administración de la primera dosis de DAC HYP en el estudio 205MS303.
    6. Las participantes que actualmente estén embarazadas o amamantando, o considerando quedarse embarazadas durante el estudio.
    7. La participación previa en el estudio 205MS303.
    8. Antecedentes de abuso de drogas o alcohol (conforme a lo definido por el investigador) en cualquier momento después del comienzo del estudio 205MS301.
    9. Negativa o imposibilidad de cumplir los requisitos del protocolo, incluida la presencia de cualquier circunstancia (física, mental o social) que pueda afectar a la capacidad del sujeto para cumplir el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Primary End Points include incidence of AEs including serious AEs (SAEs), discontinuation of DAC HYP due to AEs, and withdrawals due to AEs
    Los principales criterios de valoración incluyen la incidencia de AA incluyendo los AA graves (AAG), interrupción de DAC HYP debido a AA, y sujetos que se retiran debido a AA
    E.5.1.1Timepoint(s) of evaluation of this end point
    As necessary
    Como sea necesario
    E.5.2Secondary end point(s)
    - Shifts in clinical laboratory assessments (hematology and blood chemistry)
    - Incidence of depression as assessed by the Beck Depression Inventory, Second Edition (BDI-II)
    - Incidence of anti-DAC HYP binding antibodies (ADAbs) over time
    - Incidence of anti-DAC HYP neutralizing antibodies (NAbs) over time
    - Relapse outcomes: annualized relapse rate (ARR), and proportion of subjects who relapse
    - Sustained disability progression defined by at least a 1.0 point increase on the Expanded Disability Status Scale (EDSS) score from a baseline EDSS >=1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 12 weeks
    - Magnetic Resonance Imaging (MRI) outcomes: total number and volume of new or newly enlarging T2 hyperintense lesions, Gd-enhancing lesions, T1 hypointense lesions, and brain atrophy on brain MRI (Note: The decision to collect and analyze brain atrophy data will be made after the analysis of Study 205MS301 is complete. Brain atrophy analysis may be omitted.)
    - Change in Multiple Sclerosis Functional Composite (MSFC) score
    - Change in EDSS score
    - Proportion of subjects who are free from disease activity.
    - Proportion of subjects with sustained improvement in disability as defined by the number of subjects with baseline EDSS of at least 2.0 who experience >=1.0 decrease in EDSS that is sustained for 24 weeks.
    - Change in Multiple Sclerosis Impact Scale-29 (MSIS-29) physical and psychological scores
    - Change in quality of life as assessed by the European Quality of Life, 5 dimensions (EQ-5D and EQ VAS)
    - Change in direct HRU (hospitalizations, emergency room visits, and unscheduled neurologist visits)
    - Change in treatment satisfaction as assessed by the subject
    - Change in subject productivity as assessed by the HRPQ
    - Desviaciones en las evaluaciones analíticas clínicas (hematología y bioquímica sanguínea)
    - Incidencia de la depresión según la evaluación del Inventario de Depresión de Beck, segunda edición (BDI-II)
    - Incidencia de los anticuerpos de unión anti-DAC HYP (ADAbs) a lo largo del tiempo
    - Incidencia de los anticuerpos neutralizantes anti-DAC HYP (NAbs) a lo largo del tiempo
    - Resultados de recaídas: tasa anualizada de recaídas (TAR) y proporción de sujetos con recaída
    - Progresión mantenida de la discapacidad definida por un aumento de al menos 1,0 puntos en la puntuación de la Escala ampliada del estado de discapacidad (EDSS) con respecto a una puntuación inicial >= 1,0 que se mantenga durante 12 semanas, o un aumento de al menos 1,5 puntos en la EDSS con respecto a una puntuación inicial < 1,0 que se mantenga durante 12 semanas
    - Resultados de la resonancia magnética (RM): número y volumen total de lesiones hiperintensas en T2 nuevas o que han crecido, de lesiones realzadas con gadolinio (Gd), de lesiones hipointensas en T1 y de atrofia cerebral en la RM cerebral (nota: la decisión de recopilar y analizar los datos de atrofia cerebral se tomará una vez se complete el análisis del estudio 205MS301. Es posible que se omitan los análisis de atrofia cerebral)
    - Cambio de la puntuación en la Escala funcional compuesta de esclerosis múltiple (MSFC)
    - Cambio de la puntuación en la EDSS
    - Proporción de sujetos sin actividad de la enfermedad
    - Proporción de sujetos con una mejora mantenida de la discapacidad definida por el número de sujetos con una puntuación inicial de al menos 2,0 puntos en la EDSS que experimentan una reducción >= 1,0 puntos en la EDSS que se mantenga 24 semanas
    - Cambio de las puntuaciones físicas y psicológicas en la escala del impacto de la esclerosis múltiple de 29 ítems (MSIS-29)
    - Cambio de la calidad de vida según la evaluación del cuestionario de salud EuroQoL de 5 dimensiones (EQ-5D y EQ-EVA)
    - Cambio en el URS directo (hospitalizaciones, visitas a urgencias y visitas no programadas al neurólogo)
    - Cambio de la satisfacción con el tratamiento evaluada por el sujeto
    - Cambio en la productividad del sujeto conforme a la evaluación del HRPQ
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the course of the study
    A lo largo del curso 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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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. 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    Czech Republic
    Moldova, Republic of
    Russian Federation
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 1841
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 889
    F.4.2.2In the whole clinical trial 1841
    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)
    As per protocol
    Según protocolo
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-24
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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