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    Summary
    EudraCT Number:2019-003514-14
    Sponsor's Protocol Code Number:CL2-62798-010
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-05-06
    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 number2019-003514-14
    A.3Full title of the trial
    A Multicentre, Randomized, Double-blind, Placebo-controlled Dose-finding Study of S62798 in Patients with Intermediate-High Risk Acute Pulmonary Embolism on heparin
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo de búsqueda de dosis de S62798 en pacientes con tromboembolia pulmonar aguda de riesgo intermedio-alto en tratamiento con heparina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find the appropriate dose of S62798 to treat patients with pulmonary circulation blocked by a clot
    Un estudio para encontrar la dosis adecuada de S62798 para tratar pacientes con circulación pulmonar bloqueada por un coagulo
    A.4.1Sponsor's protocol code numberCL2-62798-010
    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 SponsorInstitut de Recherches Internationales Servier
    B.1.3.4CountryFrance
    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 supportADIR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherches Internationales Servier (I.R.I.S)
    B.5.2Functional name of contact pointClinical Studies Department
    B.5.3 Address:
    B.5.3.1Street Address50 rue Carnot
    B.5.3.2Town/ citySURESNES CEDEX
    B.5.3.3Post code92284
    B.5.3.4CountryFrance
    B.5.4Telephone number+331 55724366
    B.5.5Fax number+331 55725412
    B.5.6E-mailclinicaltrials@servier.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 nameS62798
    D.3.2Product code S62798
    D.3.4Pharmaceutical form Concentrate for 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 INNS62798
    D.3.9.2Current sponsor codeS62798
    D.3.9.3Other descriptive nameS62798
    D.3.9.4EV Substance CodeSUB184588
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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.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 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.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 nameS62798
    D.3.2Product code S62798
    D.3.4Pharmaceutical form Concentrate for 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 INNS62798
    D.3.9.2Current sponsor codeS62798
    D.3.9.3Other descriptive nameS62798
    D.3.9.4EV Substance CodeSUB184588
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    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.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 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.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 nameS62798
    D.3.2Product code S62798
    D.3.4Pharmaceutical form Concentrate for 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 INNS62798
    D.3.9.2Current sponsor codeS62798
    D.3.9.3Other descriptive nameS62798
    D.3.9.4EV Substance CodeSUB184588
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.3
    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.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 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.IMP: 4
    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 nameS62798
    D.3.2Product code S62798
    D.3.4Pharmaceutical form Concentrate for 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 INNS62798
    D.3.9.2Current sponsor codeS62798
    D.3.9.3Other descriptive nameS62798
    D.3.9.4EV Substance CodeSUB184588
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.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 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 placeboConcentrate for solution 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
    Acute intermediate high risk pulmonary embolism (PE)
    Tromboembolia pulmonar (TEP) aguda de riesgo intermedio-alto
    E.1.1.1Medical condition in easily understood language
    Pulmonary circulation blocked by a clot
    Circulación pulmonar bloqueada por un coagulo
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10037377
    E.1.2Term Pulmonary embolism
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the dose-response relationship of S62798 on the RV/LV end-diastolic diameter (EDD) 24h after treatment initiation, in patients with intermediate-high risk pulmonary embolism (PE) on heparin.
    El objetivo principal del estudio es determinar la relación dosis-respuesta de S62798 sobre la relación VD/VI de los diámetros diastólicos finales (DDF) 24 h después del inicio del tratamiento, en pacientes con riesgo intermedio-alto de tromboembolia pulmonar (TEP) tratados con heparina.
    E.2.2Secondary objectives of the trial
    ­To assess the effect of S62798 on secondary efficacy endpoints such as TAPSE, and PE-related clinical events.
    ­To assess the safety profile of S62798 in the study population.
    ­To assess the pharmacokinetics of S62798 (and metabolites if applicable).
    ­Valorar el efecto de S62798 sobre las variables exploratorias de eficacia como TAPSE y eventos clínicos relacionados con TEP.
    Valorar el perfil de seguridad de S62798 en la población del estudio.
    ­Valorar las farmacocinéticas de S62798 en la población del estudio (y metabolitos si aplica).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Acute pulmonary embolism and categorized as intermediate-high risk and documented by CT pulmonary angiography (CTPA), V/Q scan, V/Q SPECT or pulmonary angiography with emboli in at least one segmental or more proximal artery
    2. Troponin I or high sensitivity Troponin T elevated as per local lab
    3. Evidence of right ventricular dysfunction (RVD) on echocardiography or CTPA
    4. With at least one of the following clinical criteria:
    o SBP lower than 110 mmHg for > 15 min or,
    o Respiratory rate > 20 per min or SaO2 < 90% on room air or,
    o Sinus tachycardia ≥ 110 bpm sustained over 30 seconds.
    1. Tromboembolia pulmonar categorizada como riesgo intermedio-alto y documentada mediante una angiografí­a pulmonar por TC (APTC), gammagrafí­a V/Q, V/Q SPECT o angiografí­a pulmonar con un émbolo en al menos una arteria segmentaria o más proximal.
    2. Troponina I o Troponina T de alta sensibilidad elevadas según valores del laboratorio local.
    3. Evidencia de disfunción del VD valorada mediante ecocardiografí­a o APTC.
    4. Con al menos uno de los siguientes criterios;
    o TA sistólica menor de 110 mmHg durante > 15 min o,
    o Frecuencia respiratoria > 20 por min o SaO2 < 90% en aire ambiente o,
    o Taquicardia sinusal ≥ 110 lpm sostenida durante más de 30 segundos
    E.4Principal exclusion criteria
    1. Presence of right heart thrombus
    2. Reperfusion therapy planned.
    3. Patients with forbidden previous or concomitant treatment
    4. Known or pre-existing chronic pulmonary hypertension
    5. Uncontrolled hypertension defined as SBP>180 mm Hg and/or DBP >110 mm Hg
    6. Patients with a high risk of haemorrhage
    7. Patients with less than 3 months of life expectancy
    8. Platelet count lower than 100 G/L (100 000 platelets/µL), INR above 1.5 or abnormal aPTT not explained by concomitant anticoagulation therapy
    9. Positive results of pregnancy test or lacting women
    1. Presencia de trombo cardí­aco derecho
    2. Terapia de reperfusion planeada
    3. Pacientes con tratamiento previo o concomitante prohibido
    4. Hipertensión pulmonar crónica conocida o preexistente
    5. Hipertensión no controlada definida como TA sistólica > 180 mm Hg y/o TA diastólica > 110 mm Hg
    6. Pacientes con alto riesgo de hemorragia
    7. Pacientes con menos de 3 meses de esperanza de vida
    8. Recuento de plaquetas inferior a 100 G/L (100 000 plaquetas/µL), INR superior a 1,5 o aPTT anormal no explicado por el tratamiento anticoagulante concomitante
    9. Resultados positivos de la prueba de embarazo o mujeres lactantes
    E.5 End points
    E.5.1Primary end point(s)
    Right /left ventricular end-diastolic diameter (RV/LV EDD)
    relación VD/VI de los diámetros diastólicos finales (VD/VI DDF)
    E.5.1.1Timepoint(s) of evaluation of this end point
    24h (±2h) after treatment initiation
    24 h (±2h) después del inicio del tratamiento
    E.5.2Secondary end point(s)
    1. RV/LV EDD
    2. Tricuspid annular plane systolic excursion (TAPSE) estimated by echocardiography
    3. Adjudicated PE-related clinical events
    4. Pharmacokinetic measurements
    1. VD/VI DDF
    2. Desplazamiento sistólico del plano del anillo tricuspi­deo (TAPSE) estimado mediante ecografía
    3. Acontecimientos clínicos considerados relacionados con la TEP
    4. Medidas farmacocinéticas
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. For RV/LV EDD: 48h (±4h) and 30d (±2d)
    2. For tricuspid annular plane systolic excursion (TAPSE) estimated by echocardiography: 24h (±2h), 48h (±4h) and 30d (±2d)
    3. For adjudicated PE-related clinical events: Between baseline and day 30
    4. For pharmacokinetic measurements: Between baseline and day 6
    1. VD/VI DDF a las 48h (±4 h) y 30d (± 2 d)
    2. Desplazamiento sistólico del plano del anillo tricuspi­deo (TAPSE) estimado mediante ecografía a las 24 h (+/-2h), 48 h (+/- 4 h) y 30 d (+/-2d)
    3. Acontecimientos clí­nicos considerados relacionados con la TEP: Entre basal y día 30
    4. Medidas farmacocinéticas: Entre basal y dí­a 6
    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 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) 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 Yes
    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 trial5
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA97
    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
    Belgium
    Brazil
    Czech Republic
    Estonia
    Finland
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Taiwan
    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 Trial is defined as the date of the last follow-up of the last participant, or the date of the last contact attempt if the last participant is declared lost to follow-up.
    El final del ensayo se define como la fecha de la última visita de seguimiento del último paciente participante, o la fecha del último intento de contacto si el último paciente participante es declarado perdida de seguimiento.
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 185
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 185
    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 Yes
    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 258
    F.4.2.2In the whole clinical trial 370
    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)
    The participants' treatment is left to the physician's discretion. As the study drug is not licensed yet at this time, it will not be available on the market.
    El tratamiento de los participantes se deja a elección del médico. Como el medicamento del estudio aún no está aprobado, no estará disponible en el mercado.
    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 Decision2020-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-07-15
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