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    Summary
    EudraCT Number:2018-002473-21
    Sponsor's Protocol Code Number:ERGCR-18-ORGHIT-001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-10-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-002473-21
    A.3Full title of the trial
    An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)
    Étude ouverte, randomisée, contrôlée par médicament actif, multicentrique, de phase 3, pour évaluer la sécurité et l'efficacité du danaparoïde par rapport à l'argatroban dans le traitement de sujets atteints d'une TIH aiguë (étude HITSOVA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study evaluate the safety and efficacy of danaparoid vs argatroban in treatment of subjects with acute heparin-induced-thrombocytopenia (HITSOVA)
    Etude visant à démontrer que dans le traitement de sujets atteints d'une thrombocytopénie aiguë induite par l'héparine (HIT) l'utilisation de danaparoïde n'est pas inférieure à l'argatroban en termes d'efficacité (HITSOVA)
    A.3.2Name or abbreviated title of the trial where available
    HITSOVA
    HITSOVA
    A.4.1Sponsor's protocol code numberERGCR-18-ORGHIT-001
    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 SponsorAspen Global Incorporated
    B.1.3.4CountryMauritius
    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 supportAspen Global Incorporated
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErgomed
    B.5.2Functional name of contact pointBenjamin Graziani
    B.5.3 Address:
    B.5.3.1Street Address24 Avenues Des Pepnieres
    B.5.3.2Town/ cityAVRILLÉ
    B.5.3.3Post code49240
    B.5.3.4CountryFrance
    B.5.4Telephone number+336 81 00 36 02
    B.5.6E-mailgraziani.benjamin@free.fr
    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 Yes
    D.2.1.1.1Trade name Orgaran,750 anti-Xa units/0.6ml, Solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.4Pharmaceutical form 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 INNDanaparaoid sodium
    D.3.9.1CAS number 0083513-48-8
    D.3.9.3Other descriptive nameDANAPAROID SODIUM
    D.3.9.4EV Substance CodeSUB13532MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.4 to 0.8
    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 RoleComparator
    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 Exembol Multidose 100 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMitsubishi Tanabe Pharma Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Concentrate for solution for injection/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 INNArgatroban monohydrate
    D.3.9.1CAS number 74863-84-6
    D.3.9.3Other descriptive nameARGATROBAN MONOHYDRATE
    D.3.9.4EV Substance CodeSUB48842
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1 mg/ml
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Heparin-induced Thrombocytopenia (HIT)
    Thrombopénie induite par l'héparine
    E.1.1.1Medical condition in easily understood language
    Acute Heparin-induced Thrombocytopenia (HIT)
    Thrombopénie induite par l'héparine
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10062506
    E.1.2Term Heparin-induced thrombocytopenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic 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
    To show that for the treatment of subjects with acute heparin-induced thrombocytopenia (HIT) danaparoid use is not inferior to argatroban in terms of efficacy.
    Démontrer que le traitement de patients atteints de thrombocytopénie aiguë induite par l'héparine (TIH), l'utilisation de danaparoïdes n'est pas inférieure à l'argatroban en termes d'efficacité.
    E.2.2Secondary objectives of the trial
    To collect additional efficacy data
    To describe the safety of danaparoid in comparison to argatroban
    Recueillir des données d'efficacité supplémentaires
    Décrire l'innocuité du danaparoïde par rapport à l'argatroban
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At the time of enrolment subjects are eligible to be included in the study only if all of the following criteria apply:
    1. Signed written informed consent by the subject, or if the subject is unable to do so, then consent will be sought from a family member, or a legally accepted representative
    2. Males or females aged ≥2 weeks
    3. Subjects with suspected HIT by 4Ts of >3 and with reduction of platelet count of at least 30% between day 4 and 14 of heparin exposure or at Day 1 of heparin exposure with pre-treatment with heparin within the last 30 days, with or without thrombosis.
    4. Have adequate renal function: Glomerular filtration rate ≥ 15 mL/min
    5. Male participants:
    A male participant must agree to use contraception during the treatment period and for at least 5 days after the last dose of study intervention and refrain from donating sperm during this period.
    6. Female participants:
    A female participant is eligible to participate if 1 of the following conditions applies:
    a. Not a woman of childbearing potential
    OR
    b. A woman of childbearing potential who agrees to follow the contraceptive guidance during the treatment period and for at least 5 days corresponding to time needed to eliminate study intervention. (Subjects taking oral contraceptives or hormone replacement therapy must have a stable dose and regimen for ≥ 3 months prior to entry into the study.)
    7. Understanding/willingness by the subject or his/her legally accepted representative to participate in the clinical study and ability to comply with study procedures and the study visit schedule
    Au moment de l'enrôlement, les sujets sont éligibles pour l'inclusion dans l'étude uniquement si l'ensemble des critères s'applique à eux :
    1. Par sa signature, le sujet a donné par écrit son consentement informé, ou si le sujet est incapable de le faire, le consentement sera recherché auprès d'un membre de sa famille ou d'un représentant légalement accepté
    2. Sujets masculins et féminins âgés de ≥2 semaines
    3. Les sujets à TIH suspectée, dont les 4Ts > 3 et présentant une diminution de la numération plaquettaire d'au moins 30 % entre le 4ème et le 14ème jour d'exposition à l'héparine ou le 1er jour d'exposition à l'héparine avec pré-traitement à l'héparine au cours des 30 derniers jours, avec ou sans thrombose.
    4. Leur fonction rénale est adéquate : Taux de filtration glomérulaire ≥ 15 mL/min
    5. Participants de sexe masculin :
    Un participant doit convenir d'utiliser un moyen de contraception pendant la période de traitement et pendant au moins 5 jours consécutifs à la dernière dose d'intervention dans le cadre de l'étude, et de s'abstenir de donner son sperme pendant cette période.
    6. Participants de sexe féminin :
    Une participante est éligible à la participation si l'une des conditions suivantes est remplie :
    a. Il ne s'agit pas d'une femme en âge de procréer
    OU
    b. Il s'agit d'une femme en âge de procréer qui accepte de suivre des instructions de contraception pendant la période de traitement et pendant au moins 5 jours correspondant à la période requise pour éliminer la dose d'intervention dans le cadre de l'étude. (Les sujets prenant des contraceptifs oraux ou suivant une thérapie de substitution hormonale doivent avoir une dose et un régime stables pendant > 3 mois antérieurs à leur entrée dans l'étude.)
    7. Le sujet ou son représentant juridiquement accepté comprend l'étude clinique/et désire sa participation à celle-ci, et est capable de se conformer aux procédures de l'étude et au calendrier des visites dans le cadre de l'étude
    E.4Principal exclusion criteria
    At the time of enrolment subjects are excluded from the study if any of the following criteria apply:
    1. Premature infants (corrected age <37 weeks gestational age)
    2. Expectation of cardiac surgery within the next 44 days
    3. Life expectancy clearly less than the 44 days
    4. Recent fibrinolytic therapy since the start of heparin therapy leading to the target indication for enrolment, HIT
    5. Lumbar puncture or spinal/epidural catheter placement within the past 48 hours
    6. Severe hepatic impairment (Child-Pugh Class C)
    7. Active bleeding
    8. An unexplained activated partial thromboplastin time (aPTT) > 2 x the normal range
    9. Any cerebrovascular accident within the previous 3 months or has a history of haemorrhagic cerebrovascular incidence
    10. Severe, uncontrolled hypertension defined as blood pressure >180/110 mmHg
    11. Diabetic retinopathy
    12. Acute bacterial endocarditis
    13. Expectation of a long-term (> 3 weeks) haemodialysis requirement before the end of the acute treatment
    14. Hypersensitivity to the active substances or to any of the excipients
    15. Hypersensitivity to sulphite
    16. Any investigational drug(s) use within 4 weeks preceding Screening or anticipated use during the course of the study
    17. Pregnant or breastfeeding woman
    18. Use of intra-aortic balloon pump, or ventricular assist device
    Au moment de l'enrôlement, des sujets sont exclus de l'étude si s'applique à eux l'un quelconque des critères suivants :
    1. Enfants prématurés (âge corrigé < 37 semaines d'âge gestationnel)
    2. Chirurgie cardiaque attendue dans les 44 prochains jours
    3. Espérance de vie clairement inférieure à 44 jours
    4. Thérapie fibrinolytique récente depuis le démarrage de la thérapie héparique conduisant à l'indication-cible pour l'enrôlement, TIH.
    5. Ponction lombaire ou placement d'un cathéter spinal/épidural au cours des 48 heures précédentes
    6. Déficience hépatique grave (classe C de Child-Pugh)
    7. Hémorragie active
    8. Un temps partiel de thromboplastine activée inexpliqué (aPTT) > 2 fois la plage normale
    9. Tout accident vasculaire cérébral au cours des 3 mois précédents ou patient avec antécédents d'incidence hémorragique vasculaire cérébrale.
    10. Hypertension grave non contrôlée définie par une pression sanguine > 180/110 mmHg.
    11. Rétinopathie diabétique
    12. Endocardite bactérienne aiguë
    13. Prévision d'une nécessité d'hémodialyse longue durée (> 3 semaines) avant la fin du traitement aigu
    14. Hypersensibilité aux substances actives ou à l'un des excipients
    15. Hypersensibilité au sulfite
    16. Utilisation d'un ou plusieurs médicament(s) d'étude au cours des 4 semaines précédant le dépistage, ou dont l'utilisation est à attendre pendant le déroulement de l'étude.
    17. Femme enceinte ou allaitante
    18. Utilisation d'une pompe à ballonnet intra-aortique ou d'un dispositif d'assistance ventriculaire
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint (composite endpoint) is defined as treatment response at Day 44.
    A subject will be considered a treatment responder, if none of the following events occur by Day 44:
    • New or extended venous and/or arterial thrombosis, including gangrene/skin necrosis
    Note: ‘thrombosis’ denotes venous and/or arterial here and throughout the protocol
    • All-cause mortality
    • Unplanned amputation, including ischaemic gut resection
    Le critère d'efficacité principal (critère composite) est défini comme étant la réponse au traitement le 44ème jour.
    Un sujet sera considéré comme répondant au traitement si aucun des événements suivants ne se produit d'ici au 44ème jour :
    • Thrombose veineuse et/ou artérielle nouvelle ou étendue, avec gangrène/nécrose de la peau
    Remarque : Ici et dans l'ensemble du protocole, la « thrombose » est veineuse et/ou artérielle.
    • Mortalité toutes causes confondues
    • Amputation imprévue, y compris la résection d'un segment intestinal ischémique.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 44
    Jour 44
    E.5.2Secondary end point(s)
    Secondary
    • Percentage of subjects with consistent increases in platelets at days 3, 5, and 7 (evidence of early response), defined as monotonically increasing platelet counts, measured 2 days apart on days 3 (±1 day), 5 (±1 day) and 7 (±1 day).
    • Deaths due to TE or bleeding up until Day 44
    • Incidence of fatal or non-fatal major bleeding up until Day 44
    Note: As outlined by the Control of Anticoagulation Subcommittee major bleeding in non-surgical patients is defined as:
    1. Fatal bleeding, and/or
    2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or
    3. Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/ L) or more, or leading to transfusion of two or more units of whole blood or red cells
    • New or extended thrombosis, including gangrene/skin necrosis
    • Unplanned amputation, including ischaemic gut resection
    • All-cause mortality
    Exploratory
    • Time to first event (new/extended thrombosis, all cause mortality, unplanned amputation)
    • Time to reach consistent increase in 3 consecutive alternate day platelet count measurements during acute treatment
    • Incidence of new or extended TE events, including gangrene/skin necrosis up until Day 14
    • Incidence of all-cause mortality up until Day 14
    • Incidence of unplanned amputation up until Day 14
    • Incidence of fatal or non-fatal major bleeding up until Day 14
    • All-cause mortality
    • Incidence of fatal and non-fatal major bleeding events (as defined above) during the acute treatment and then the entire follow-up period (until Day 44)
    • Incidence of serious adverse events (SAEs)
    • Incidence of adverse events (AEs)
    • Changes in vital parameters (heart rate, blood pressure, and respiratory rate) and 12-lead electrocardiogram (ECG)
    • Incidence of positive pre-danaparoid cross reactivity in the Greinacher Heparin-induced Platelet Activation (HIPA) assay
    • Safety laboratory parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    Increases in platelets at days 3,5,7
    Death until Day 44
    Bleeding at Day 44
    Time to first bleeding
    Time to reach consistent increase in 3 consecutive alternate day platelet count measurements during acute treatment
    Incidence of new event until Day 14
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Bosnia and Herzegovina
    Bulgaria
    Canada
    Croatia
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Poland
    Russian Federation
    Serbia
    Spain
    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
    Last patient last visit
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 12
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 4
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 4
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 486
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patient can develop a cardio-pulmonar thrombosis/embolism /cerebrovascular event and might be in the situation where a direct cooperation with the patient is not possible (patient is unconscious due to the event or because of the intensive treatment
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 508
    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)
    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 Decision2018-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-06-10
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