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    Summary
    EudraCT Number:2018-000539-29
    Sponsor's Protocol Code Number:POISE-3
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-000539-29
    A.3Full title of the trial
    PeriOperative ISchemic Evaluation – 3 Trial (POISE-3).
    Valutazione dell’ischemia perioperatoria - 3 (POISE-3)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of strategies aiming at controlling perioperative ischemia - 3 (POISE-3)
    Valutazione di strategie di controllo dell’ischemia perioperatoria – 3 (POISE-3)
    A.3.2Name or abbreviated title of the trial where available
    POISE-3
    POISE-3
    A.4.1Sponsor's protocol code numberPOISE-3
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03505723
    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 SponsorHamilton Health Sciences Corporation
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPopulation Health Research Institute
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Ospedale San Raffaele
    B.5.2Functional name of contact pointAnestesia e Rianimazione Cardio-Tor
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina, 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.6E-maillandoni.giovanni@hsr.it
    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 UGUROL
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameUGUROL
    D.3.2Product code [021458029]
    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 INNACIDO TRANEXAMICO
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    The occurrence of life-threatening, major, and critical organ bleeding in patients who are undergoing noncardiac surgery.
    Insorgenza di complicanze emorragiche maggiori, che mettono a rischio la vita del paziente e coinvolgono organi critici dopo chirurgia non cardiaca.
    E.1.1.1Medical condition in easily understood language
    Postoperative bleeding in patients receiving non-cardiac surgery.
    Emorragia post operazione di chirurgia non cardiaca.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10051014
    E.1.2Term Post procedural bleeding
    E.1.2System Organ Class 100000004863
    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 if tranexamic acid is superior to placebo for the occurrence of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, within 30 days after surgery, in patients at risk of bleeding and cardiovascular events who are undergoing non-cardiac surgery. Furthermore, in the same population using a partial factorial design, to determine the effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the 30-day risk of a major cardiovascular event (i.e., a composite of vascular death, and nonfatal myocardial infarction, stroke, and cardiac arrest).
    L’obiettivo principale è di determinare la superiorità di acido tranexamico rispetto al placebo per quanto riguarda l’incidenza di sanguinamento potenzialmente fatale, sanguinamento d’organo critico, sanguinamento maggiore e la non inferiorità di acido tranexamico rispetto al placebo per quanto riguarda l’incidenza di trombosi maggiori arteriose e venose a 30 giorni dalla data della randomizzazione in pazienti con, o a rischio di, patologia aterosclerotica sottoposti a chirurgia non cardiaca. Inoltre, nella medesima popolazione di soggetti, ci poniamo l’obiettivo di determinare, usando un disegno sperimentale fattoriale parziale, se una strategia perioperatoria di prevenzione dell’ipotensione sia superiore a una strategia perioperatoria di prevenzione dell’ipertensione nell’incidenza di morte per cause vascolari, infarto miocardico non fatale, stroke, arresto cardiaco, a 30 giorni dalla data della randomizzazione.
    E.2.2Secondary objectives of the trial
    To determine the impact of TXA on the following outcomes at 30 days after randomization: a net risk-benefit outcome as a composite of vascular death, and nonfatal life-threatening bleeding, and nonfatal major bleeding, critical organ bleeding, myocardial injury after noncardiac surgery (MINS), stroke, peripheral arterial thrombosis, and symptomatic venous thromboembolism; International Society on Thrombosis and Haemostasis (ISTH) major bleeding; bleeding independently associated with mortality after noncardiac surgery (BIMS); MINS; MINS not fulfilling the 3rd universal definition of myocardial infarction (MI); and myocardial infarction.
    To determine the impact of a perioperative hypotension-avoidance strategy on all-cause mortality; MINS; and myocardial infarction at 30 days after randomization.
    Determinare l’impatto dell’acido tranexamico sui seguenti outcome a 30 giorni dalla randomizzazione: rapporto rischio-beneficio netto valutato come outcome composito composto da morte vascolare, sanguinamento critico non fatale, sanguinamento maggiore non fatale, sanguinamento di organo vitale, danno miocardico dopo intervento chirurgico non cardiaco (MINS), ictus, trombosi arteriosa periferica, e tromboembolia venosa prossimale sintomatica; sanguinamento maggiore secondo i criteri dell’International Society on Thrombosis and Haemostasis (ISTH); sanguinamento associato indipendentemente dalla mortalità dopo intervento chirurgico non cardiaco (BIMS); MINS; MINS che non rientra nella terza definizione universale di infarto miocardico (MI); e infarto miocardico.
    Determinare l’impatto di una strategia perioperatoria di prevenzione della ipotensione su tutte le cause di morte; MINS; e infarto miocardico a 30 giorni dalla randomizzazione.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Minimizing perioperative bleeding and hypotension to reduce postoperative delirium and cognitive decline after noncardiac surgery: the cogPOISE-3 randomized controlled trial. A POISE-3 substudy. Version 1.0, 2019-05-28. The primary objective is to determine the effect of TXA and a hypotension avoidance strategy on postoperative delirium (as measured by the Confusion Assessment Method [CAM]) during the first 3 days after surgery, or until discharge, whichever occurs first. The secondary objectives are to determine the effect of TXA and a hypotension avoidance strategy on postoperative cognitive dysfunction at 1 year after randomization defined as a decrease of =2 points in MoCA score at 1 year compared with baseline; and on the change of the performance at the Digit-Symbol Substitution Test [DSST] at 1 year compared with baseline. We will also determine the effect of TXA and a hypotension avoidance strategy on the severity of postoperative delirium/confusion.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Limitare il sanguinamento perioperatorio e l’ipotensione per ridurre l’incidenza di delirium postoperatorio e di declino cognitivo dopo chirurgia non cardiaca: cogPOISE-3 randomized controlled trial. Un sottostudio POISE-3 Versione 1.0, 2019-05-28. L’obiettivo primario è quello di determinare l’effetto dell’Acido Tranexamico e della strategia di evitamento dell’ipotensione sul delirium postoperatorio (definito attraverso il Confusion Assessment Method [CAM]) durante i primi 3 giorni dopo chirurgia, o prima della dimissione, se precedente. Gli obiettivi secondari sono: determinare l’effetto dell’Acido Tranexamico e della strategia di evitamento dell’ipotensione sulla disfunzione cognitiva postoperatoria a 1 anno dalla randomizzazione definita come decremento =2 puntinel MoCA score a 1 anno confrontato con il basale e come modificazione della performance al Digit-Symbol Substitution Test [DSST] a 1 anno confrontato con il basale. Determineremo inoltre l’effetto dell’Acido Tranexamico e della strategia di evitamento dell’ipotensione sulla severità di delirium/confusione postoperatori.
    E.3Principal inclusion criteria
    o Undergoing noncardiac surgery;
    o >= 45 years of age;
    o Expected to require at least an overnight hospital admission after surgery
    o Provide written informed consent to participate in the POISE-3 Trial, AND
    o Fulfill >=1 of the following:
    • NT-proBNP >= 200 ng/L
    • History of coronary artery disease
    • History of peripheral arterial disease
    • History of stroke
    • Undergoing major vascular surgery
    • Any 3 of 9 risk criteria
    o Undergoing major surgery
    o History of congestive heart failure
    o History of a transient ischemic attack
    o Diabetes and currently taking an oral hypoglycemic agent or insulin
    o Age >= 70 years
    o History of hypertension
    o Serum creatinine > 175 µmol/L (> 2.0 mg/dl)
    o History of smoking within 2 years of surgery
    o Undergoing emergent/urgent surgery.
    Patients will be eligible for inclusion in the cogPOISE-3 substudy if they are enrolled in both the TXA and blood pressure management arms of the POISE-3 trial. cogPOISE-3 patients will be included in the cognitive assessment part of the substudy if they consent to the assessment of their cognitive performance at baseline (i.e., within 30 days prior to randomization) and at 1 year after randomization. Patients with a documented history of dementia will not be eligible for the cognitive
    assessment part of the substudy.
    o Pazienti sottoposti a chirurgia non cardiaca
    o >= 45 anni di età
    o previsto ricovero ospedaliero di almeno una notte dopo chirurgia non cardiaca
    o ottenimento del consenso informato alla partecipazione allo studio E
    o Uno dei seguenti criteri:
    • NT-pro-BNP preoperatorio >= 200ng/L
    • storia di coronaropatia;
    • storia di patologia vascolare periferica;
    • storia di stroke;
    • paziente sottoposto a chirurgia vascolare maggiore;
    • almeno 3 tra i seguenti 9 criteri:
    o paziente sottoposto a chirurgia maggiore (ad esempio: intraperitoneale, intratoracica, retroperitoneale o chirurgia ortopedica maggiore)
    o storia di scompenso cardiaco congestizio
    o attacco ischemico transitorio
    o paziente diabetico in trattamento con ipoglicemizzanti orali o insulina
    o età >=70 anni
    o ipertensione
    o creatinina sierica > 175 micromol/L (>2.0 mg/dl)
    o esposizione al fumo di sigaretta nei due anni precedenti l’intervento chirurgico
    o paziente sottoposto a chirurgica d’urgenza/emergenza.
    I pazienti saranno candidabili all’inclusione nel sottostudio cogPOISE-3 se arruolati sia nel braccio TXA che nel braccio gestione della pressione arteriosa del POISE-3. I pazienti del cogPOISE-3 saranno inclusi nella parte di valutazione cognitiva del sottostudio se danno il consenso alla valutazione della loro performance cognitiva al baseline (per esempio, entro 30 giorni prima della randomizzazione) e a 1 anno dalla randomizzazione. Pazienti con una storia documentata di demenza non saranno candidabilli alla parte di valutazione cognitiva del sottostudio.
    E.4Principal exclusion criteria
    o Patients undergoing cardiac surgery
    o Patients undergoing cranial neurosurgery
    o Planned use of systemic TXA during surgery
    o Hypersensitivity or known allergy to TXA
    o Creatinine clearance <30 mL/min (Cockcroft-Gault equation) or on chronic dialysis
    o Patients undergoing surgery for pheochromocytoma or history of untreated pheochromocytoma,
    o History of seizure disorder
    o Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous
    thromboembolism (<3 month)
    o Patients with fibrinolytic conditions following consumption coagulopathy
    o Patients with subarachnoid hemorrhage within the past 30 days
    10. Women of childbearing potential who are not taking effective contraception, pregnant or breast-
    feeding
    o Previously enrolled in POISE-3 Trial
    o paziente sottoposto a chirurgia cardiaca
    o paziente sottoposto a neurochirurgica intracranica
    o previsto uso sistemico di TXA durante la chirurgia
    o Ipersensibilità o nota allergia a TXA
    o Clearance della creatinina <30 ml/min (secondo formula di Cockcroft-Gault) oppure paziente in terapia dialitica cronica
    o Interventi chirurgici a basso rischio (secondo il giudizio individuale dello sperimentatore)
    o Storia di disturbo epilettico
    o Recente storia di ictus, infarto miocardico, trombosi arteriosa acuta o tromboembolismo venoso (<3 mesi)
    o Paziente in stato fibrinolitico a seguito di coagulopatia da consumo
    o Paziente con emorragia subaracnoidea negli ultimi 30 giorni
    o Donne in gravidanza, allattamento o in età fertile che non utilizzano metodi contraccettivi efficaci
    o Paziente già precedentemente arruolato nello studio POISE-3
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary efficacy outcome for TXA trial is a composite of life-threatening bleeding, major bleeding, and critical organ bleeding at 30 days after randomization. The co-primary safety outcome for TXA trial is a composite of myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism at 30 days after randomization.
    The primary outcome for the BP management trial is a composite of vascular death, and non-fatal myocardial injury after noncardiac surgery, non-fatal stroke, and non-fatal cardiac arrest at 30 days after randomization.
    L’outcome co-primario di efficacia per lo studio sull’acido tranexamico è composto da sanguinamento critico, sanguinamento maggiore e sanguinamento di organo vitale a 30 giorni dalla randomizzazione.
    L’outcome co-primario di sicurezza per lo studio sull’acido tranexamico è composto da danno miocardico dopo intervento chirurgico non cardiaco, ictus non emorragico, trombosi arteriosa periferica, e tromboembolia venosa prossimale sintomatica a 30 giorni dalla randomizzazione.
    L’outcome primario per lo studio sulla gestione della pressione arteriosa è composto da morte vascolare, danno miocardico non fatale dopo intervento chirurgico non cardiaco, ictus non fatale e arresto cardiaco non fatale a 30 giorni dalla randomizzazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During hospital stay and at 30 days after randomization.
    Per tutto il tempo del ricovero e 30 giorni dopo la randomizzazione.
    E.5.2Secondary end point(s)
    The secondary outcomes for TXA trial are: 1) a net risk-benefit outcome as a composite of vascular death, and non-fatal life-threatening, major
    or critical organ bleeding, myocardial injury after noncardiac surgery, stroke, peripheral arterial thrombosis, and symptomatic proximal venous
    thromboembolism at 30 days after randomization; 2) International Society on Thrombosis and Haemostasis (ISTH) major bleeding; 3)
    BIMS; 4) MINS; 5) MINS not fulfilling the 3rd universal definition of myocardial infarction and 6) myocardial infarction at 30 days after
    randomization. The secondary outcomes for the BP management factorial are: 1) allcause mortality at 30 days after randomization; 2) MINS; and 3)
    myocardial infarction at 30 days after randomization.
    Gli outcome secondari per lo studio sull’acido tranexamico sono: 1) rapporto rischio-beneficio netto valutato come outcome composito composto da morte vascolare, sanguinamento critico non fatale, maggiore o di organo vitale, danno miocardico dopo intervento chirurgico non cardiaco, ictus, trombosi arteriosa periferica, e tromboembolia venosa prossimale sintomatica 30 giorni dopo la randomizzazione; sanguinamento maggiore secondo i criteri dell’International Society on Thrombosis and Haemostasis (ISTH) 3) BIMS; 4) MINS; 5) MINS che non rientra nella terza definizione universale di infarto miocardico; e 6) infarto miocardico a 30 giorni dalla randomizzazione. Gli outcome secondari per lo studio sulla gestione della pressione sanguigna sono: 1) tutte le cause di mortalità a 30 giorni dalla randomizzazione; 2) MINS; e 3) infarto miocardico a 30 giorni dalla randomizzazione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days and 1 year after randomization
    30 giorni e ad 1 anno dalla randomizzazione
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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 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 trial4
    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 concerned31
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Chile
    China
    Colombia
    Hong Kong
    India
    New Zealand
    Saudi Arabia
    South Africa
    Uganda
    United States
    Austria
    Belgium
    Denmark
    France
    Germany
    Ireland
    Italy
    Netherlands
    Poland
    Romania
    Spain
    Switzerland
    United Kingdom
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    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 months0
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In 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: 750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 750
    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 state1500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2800
    F.4.2.2In the whole clinical trial 10000
    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)
    Good clinical practice
    Normale Pratica Clinica
    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 Decision2019-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-11
    P. End of Trial
    P.End of Trial StatusOngoing
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