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    EudraCT Number:2015-001824-43
    Sponsor's Protocol Code Number:DS1040-A-U103
    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:2016-12-27
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2015-001824-43
    A.3Full title of the trial
    A Phase 1b/2, multi-center, double-blind (principal investigators and study subjects blinded, sponsor unblinded), placebo-controlled, randomized, single-ascending dose study to assess the safety, pharmacokinetics, and pharmacodynamics of DS-1040B in subjects with acute ischemic stroke.
    Estudio de fase Ib/II, multicéntrico, aleatorizado, con doble enmascaramiento (con enmascaramiento para los investigadores principales y los sujetos del estudio, sin enmascaramiento para el promotor), controlado con placebo, de dosis única ascendente, para evaluar la seguridad, la farmacocinética y la farmacodinámica de DS-1040b en sujetos con ictus isquémico agudo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1b/2 study to assess the safety, pharmacokinetics, and pharmacodynamics of DS-1040B in subjects with acute ischemic stroke.
    Estudio de fase Ib/II para evaluar la seguridad, la farmacocinética y la farmacodinámica de DS-1040b en sujetos con ictus isquémico agudo.
    A.4.1Sponsor's protocol code numberDS1040-A-U103
    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 SponsorDaiichi Sankyo, Inc.
    B.1.3.4CountryUnited States
    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 supportDaiichi Sankyo, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Contact
    B.5.3 Address:
    B.5.3.1Street Address399 Thornall Street
    B.5.3.2Town/ cityEdison
    B.5.3.3Post codeNJ 08837
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34916307447
    B.5.5Fax number+1732906 5690
    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 nameDS-1040b
    D.3.2Product code DS-1040b
    D.3.4Pharmaceutical form Solution for infusion
    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 INNDS-1040B
    D.3.9.2Current sponsor codeDS-1040B
    D.3.9.3Other descriptive nameDS-1040B
    D.3.9.4EV Substance CodeSUB128772
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 infusion
    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
    DS-1040b is an inhibitor of the activated form of thrombin-activatable fibrinolysis inhibitor (TAFIa) intended to be used for the treatment of thrombotic diseases including acute ischemic stroke (AIS).
    DS-1040b es un inhibidor de la forma activada de la fibrinólisis activado por trombina (thrombin-activatable fibrinolysis inhibitor, TAFI) destinado a ser utilizado para el tratamiento de las enfermedades trombóticas incluyendo el ictus isquémico agudo (IIA).
    E.1.1.1Medical condition in easily understood language
    Acute Ischemic Stroke
    Ictus Isquémico Agudo
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of DS-1040b (IV infusion over 6 hours) in subjects with AIS within 4.5 to 12 hours after stroke symptom onset
    Evaluar la seguridad y la tolerabilidad de DS-1040b (perfusión intravenosa [IV] durante 6 horas) en sujetos con IIA entre 4,5 y 12 horas después de la aparición de los síntomas de ictus.
    E.2.2Secondary objectives of the trial
    1. To assess plasma and urinary pharmacokinetics (PK) of DS-1040b in subjects with AIS.
    2. To assess the effect of DS-1040b on fibrinolysis biomarkers in subjects with AIS.
    3. To assess the effect of DS-1040b on recanalization at 24 hours in subjects with AIS and a visible occlusion demonstrated on brain imaging at predose.
    4. To assess the effect of DS-1040b on neurological outcome by using the National Institute of Health Stroke Scale (NIHSS) and functional outcome by using the modified Rankin Scale (mRS) in subjects with AIS.
    1. Evaluar la farmacocinética (FC) plasmática y urinaria de DS-1040b en sujetos con IIA.
    2. Evaluar el efecto de DS-1040b sobre los biomarcadores de fibrinólisis en sujetos con IIA.
    3. Evaluar el efecto de DS-1040b sobre la recanalización a las 24 horas en sujetos con IIA y una oclusión visible demostrada mediante imágenes del cerebro antes de la dosis.
    4. Evaluar el efecto de DS-1040b sobre el resultado neurológico utilizando la Escala de Ictus del Instituto Nacional de la Salud (National Institute of Health Stroke Scale, NIHSS) de los EE.UU. y sobre el resultado funcional utilizando la escala modificada de Rankin (modified Rankin Scale, mRS) en sujetos con IIA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects have a clinical diagnosis of acute ischemic stroke (including lacunar stroke) supported by computed topography or magnetic resonance imaging.
    2. Men and women 18 years of age and older.
    3. Subjects have stroke symptoms onset within 4.5 to 12 hours before initiation of study drug administration. For subjects with a wake-up stroke, symptoms onset time refers to the last time the subject was known to be well.
    4. Subjects have a NIHSS score of >2 .
    5. Subjects, (or their legally authorized representative -where applicable and based on country-specific practice), must give written informed consent to participate in the study prior to participating in any study-related procedures. A separate written informed consent is required for collecting a blood sample for genotyping.
    1. Tener un diagnóstico clínico de ictus isquémico agudo (incluido el ictus lacunar) respaldado por imágenes de tomografía computarizada o resonancia magnética.
    2. Ser hombre o mujer de 18 años de edad como mínimo.
    3. Tener síntomas de ictus aparecidos entre 4,5 y 12 horas antes del inicio de la administración del fármaco del estudio. En el caso de sujetos con ictus del despertar, el tiempo de aparición de los síntomas se refiere a la última vez en que se sabe que el sujeto se encontraba bien.
    4. Tener una puntuación NIHSS ≥ 2.
    5. Los sujetos (o su representante legal, cuando corresponda y teniendo en cuenta la práctica específica de cada país) deberán otorgar su consentimiento informado por escrito para participar en el estudio antes de poder participar en cualquier procedimiento relacionado con el mismo. Será necesario un consentimiento informado escrito independiente para la recogida de una muestra de sangre para genotipado.
    E.4Principal exclusion criteria
    1.Subjects have been treated or are anticipated to be treated with tissue plasminogen activator and/or endovascular thrombectomy during current stroke. Eligible subjects declining these treatments can be enrolled to this study.
    2. Subjects have evidence of intracranial hemorrhage on noncontrast computed tomography (CT) (or magnetic resonance [MR]).
    3. Subjects have symptoms of subarachnoid hemorrhage, even with normal CT.
    4. Subjects have an Alberta Stroke Program Early CT Score (ASPECTS) < 6.
    5. Subjects have prior non-traumatic intracranial haemorrhage(excluding microhemorrahages observed in imaging).
    6. Subjects have known arteriovenous malformation or aneurysm.
    7. Subjects have evidence of active bleeding.
    8. Subjects have platelet count < 100,000.
    9. Subjects have INR>1.7.
    10. Subjects have used unfractionated heparin within 24 hours prior to treatment and have an elevated partial thromboplastin time.
    11. Subjects have used a nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 24 hours prior to treatment.
    12. Subjects have used fondaparinux or low molecular weight heparin at an anticoagulation dose within 24 hours prior to treatment.
    13. Subjects with anticipated use of an anticoagulation dose of heparin, or fondaparinux or low molecular weight heparin, or nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours of randomization. Low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment start and after no intracranial bleeding has been confirmed on 24 hours repeat brain imaging.
    14. Subjects have blood pressure>185/110 mmHg, or require aggressive medication to maintain blood pressure below this limit (routine medical treatment is allowed to lower the blood pressure below this limit).
    15. Subjects have had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 1 month.
    16. Subjects have had major surgery within 14 days.
    17. Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days.
    18. Subjects have had a lumbar puncture (or epidural steroid injection) within 14 days.
    19. Subjects have a preexisting disability classified by mRS>2.
    20. Subjects have an estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation)<60 mL/min/1.73 m2.
    21. Subjects have baseline hemoglobin<10.5 g/dL.
    22. Subjects have a positive pregnancy test. Serum or urine pregnancy tests will be performed (according to site-specific practice) in women of childbearing potential (childbearing potential is assumed in women up to 55 years of age).
    23. Subject is currently participating in another investigational study or has participated in an investigational drug study within 30 days or 5 half-lives of that investigational drug prior to administration of the study drug.
    24. Subject is an employee or an immediate family member of an employee of the Sponsor, the CRO (INC Research), or the Site.
    25. Any other reason, in the opinion of the Investigator, which precludes subject participation in the study.
    1. Haber sido tratados o tener previsto el tratamiento con activador tisular del plasminógeno y/o mediante trombectomía endovascular durante el ictus actual.
    Se podrá inscribir en el estudio a los sujetos aptos que rehúsen esos tratamientos.
    2. Presentar indicios de hemorragia intracraneal en la tomografía computarizada (TAC) (o en la resonancia magnética [RM]) sin contraste.
    3. Presentar síntomas de hemorragia subaracnoidea, incluso con una TAC normal.
    4. Tener una puntuación < 6 en la escala Alberta Stroke Program Early CT Score (ASPECTS).
    5. Tener una hemorragia intracraneal no traumática previa (excluidas las microhemorragias observadas en los estudios por imágenes).
    6. Tener una malformación arteriovenosa o aneurisma conocidos.
    7. Presentar indicios de sangrado activo.
    8. Tener un recuento plaquetario de 100 000.
    9. Tener un índice internacional normalizado (INR)  1,7.
    10. Haber usado heparina no fraccionada en las 24 horas anteriores al tratamiento y tener un tiempo de tromboplastina parcial elevado.
    11. Haber usado un anticoagulante oral no antagonista de la vitamina K, como dabigatrán, rivaroxabán, apixabán u otros inhibidores del factor Xa en las 24 horas anteriores al tratamiento.
    12. Haber usado fondaparinux o heparina de bajo peso molecular a una dosis anticoagulante en las 24 horas anteriores al tratamiento.
    13. Tener previsto el uso de una dosis anticoagulante de heparina, o de fondaparinux o de heparina de bajo peso molecular, o de anticoagulante oral no antagonista de la vitamina K como dabigatrán, rivaroxabán, apixabán u otros inhibidores del factor Xa en las 48 horas anteriores a la aleatorización. Se permite el uso de heparina a baja dosis o de heparina de bajo peso molecular a una dosis preventiva desde 24 horas después del inicio del tratamiento y tras la confirmación de la ausencia de sangrado intracraneal en la repetición a las 24 horas del estudio por imagen del cerebro.
    14. Tener una presión arterial de 185/110 mm Hg, o necesitar medicación agresiva para mantener la presión arterial por debajo de ese límite (se permite el tratamiento médico habitual para disminuir la presión arterial por debajo de ese límite).
    15. Haberse sometido a una intervención quirúrgica intracraneal o haber tenido un traumatismo craneal clínicamente significativo (en opinión del investigador principal), tratamiento con alteplasa o un ictus previo en el mes anterior.
    16. Haberse sometido a cirugía mayor en los 14 días anteriores.
    17. Haber sufrido un sangrado gastrointestinal o genitourinario en los últimos 21 días.
    18. Haberse sometido a una punción lumbar (o haber recibido una inyección epidural de esteroides) en los 14 días anteriores.
    19. Tener una discapacidad preexistente clasificada con mRS  2.
    20. Tener un índice de filtración glomerular estimado (calculado con la ecuación de la modificación de la dieta en la enfermedad renal)  60 ml/min/1,73 m2.
    21. Tener un valor de hemoglobina inicial  10,5 g/dl.
    22. Tener un resultado positivo en una prueba de embarazo. Se realizarán pruebas de embarazo en suero o en orina (según la práctica específica del centro) a las mujeres con capacidad de concebir (se supone la capacidad de concebir en las mujeres de hasta 55 años de edad).
    23. Estar participando actualmente en otro estudio de investigación o haber participado en un estudio con un fármaco en investigación en el período de 30 días o de 5 semividas de ese fármaco en investigación con anterioridad a la administración del fármaco del estudio.
    24. Ser empleado o familiar directo de un empleado del promotor, la CRO (INC Research) o del centro.
    25. Cualquier otro motivo que, en opinión del investigador, excluya la participación del paciente en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    • Safety parameters:
    Safety parameters will include adverse events occurrence,physical examination findings, vital sign measurements, standard clinical laboratory parameters (including serum chemistry, hematology, urinalysis, and coagulation parameters), and electrocardiogram (ECG) parameters.
    Other safety parameters will include bleeding events and neurologic function. Bleeding events will be assessed and categorized as sICH, any intracranial hemorrhage (ICH), or non-ICH major bleeding. Neurologic function will be measured using the NIHSS.
    • Parámetros de seguridad:
    Los parámetros de seguridad serán: incidencia de acontecimientos adversos, hallazgos en la exploración física, mediciones de las constantes vitales, parámetros analíticos clínicos habituales (incluidos los parámetros de bioquímica sérica, hematología, análisis de orina y coagulación) y parámetros electrocardiográficos (ECG).
    Otros parámetros de seguridad serán los episodios de sangrado y la función neurológica. Los episodios de sangrado se evaluarán y clasificarán como hemorragia intracraneal sintomática (HICs), cualquier hemorragia intracraneal (HIC) o sangrado mayor no HIC. La función neurológica se medirá mediante la NIHSS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, day 2, day 3, day 4, day 5 and at follow up (day 30 and day 90).
    Día 1, día 2, día 3, día 4, día 5 y seguimiento (día 30 y día 90).
    E.5.2Secondary end point(s)
    • Pharmacokinetic parameters:
    Standard noncompartmental PK parameters will be assessed. Plasma samples for PK assessments will be taken at multiple timepoints in the study. Additionally, a PK sample may also be obtained outside of the specified timepoints during the study if deemed clinically necessary. Urine PK samples will also be collected and evaluated in the study.
    • Pharmacodynamic parameters:
    Pharmacodynamic analysis for TAFIa antigen and clot lysis along with D-dimer and total TAFIa activity will be performed. Remaining blood samples will be used for post-hoc TAFIa inhibition-related coagulation biomarker assessments.
    Recanalization will be assessed during the study.
    • Other parameters:
    An assessment of functional outcome using the mRS will be performed during the study.
    • Parámetros farmacocinéticos
    Se analizarán los parámetros FC estándar no compartimentales. Se tomarán muestras de plasma para análisis FC en diferentes momentos del estudio. Adicionalmente, se podría obtener un muestra para FC fuera de los momentos específicados durante el estudio si se considera clínicamente necesario. También se recogerán y analizarán muestras de orina para FC en el estudio.
    • Parámetros farmacodinámicos:
    Se realizarán análisis farmacodinámicos para el inhibidor de la fibrinólisis activado por trombina (thrombin-activatable fibrinolysis inhibitor, TAFI) antigénico, la lisis de coágulos, el dímero D y la actividad del TAFIa total. Las muestras de sangre sobrantes se utilizarán para evaluaciones post hoc de biomarcadores de coagulación relacionados con la inhibición del TAFIa.
    Se evaluará la recanalización durante el estudio.
    • Otros parámetros
    Se evaluará el resultado funcional durante el estudio utilizando la mRS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK: Day 1, day 2, day 3, day 4 and day 5
    PD: Day 1, day 2 and day 3
    FC: Día 1, día 2, día 3, día 4 y día 5
    FD: Día 1, día 2 y día 3
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E. trial type description
    1B/2 (single-ascending dose)
    1B/2 (estudio de dosi única ascendente)
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Korea, Republic of
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Última Visita Último Sujeto
    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 months6
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 96
    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)
    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 Decision2017-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-13
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