[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467180":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":183,"collaborators":185,"id":188,"slug":189,"hasResults":190,"nctId":191,"briefTitle":192,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":190,"sex":195,"minAge":196,"maxAge":32,"enrollmentInfo":197,"targetDuration":32,"studyType":200,"phases":201,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":50,"whyStopped":32,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},{"fullName":5,"class":6},"The Florey Institute of Neuroscience and Mental Health","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"TBO-309 30mg (25% of target dose)","EXPERIMENTAL","Following randomisation, 30mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical.\n\nThe allocated dose of TBO-309 will be given intravenously as follows:\n\n* 20% of the dose will be administered as a bolus over approximately one minute; then\n* the remainder of the dose (80%) will be administered over 3 hours as an infusion\n\nOnly one dose will be administered to the patient.",[13],"Drug: TBO-309",{"label":15,"type":10,"description":16,"interventionNames":17},"TBO-309 60mg (50% of target dose)","Following randomisation, 60mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical.\n\nThe allocated dose of TBO-309 will be given intravenously as follows:\n\n* 20% of the dose will be administered as a bolus over approximately one minute; then\n* the remainder of the dose (80%) will be administered over 3 hours as an infusion\n\nOnly one dose will be administered to the patient.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"TBO-309 120mg (100% of target dose)","Following randomisation, 120mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical.\n\nThe allocated dose of TBO-309 will be given intravenously as follows:\n\n* 20% of the dose will be administered as a bolus over approximately one minute; then\n* the remainder of the dose (80%) will be administered over 3 hours as an infusion\n\nOnly one dose will be administered to the patient.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"TBO-309 180mg (150% of target dose)","Following randomisation, 180mg TBO-309 will be administered at the same time as the rt-PA infusion or tenecteplase bolus (as part of intravenous thrombolysis) or as soon as practical.\n\nThe allocated dose of TBO-309 will be given intravenously as follows:\n\n* 20% of the dose will be administered as a bolus over approximately one minute; then\n* the remainder of the dose (80%) will be administered over 3 hours as an infusion\n\nOnly one dose will be administered to the patient.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","TBO-309","TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion\u002Faggregation and promotes platelet disaggregation, thereby specifically inhibiting thrombosis without interfering with normal haemostasis.",[19,23,9,15],null,[34],{"name":35,"affiliation":36,"role":37},"Candice Delcourt, Dr","The George Institute","STUDY_CHAIR",[39,43],{"name":35,"role":40,"phone":41,"phoneExt":32,"email":42},"CONTACT","+61 2 8052 4601","cdelcourt@georgeinstitute.org.au",{"name":44,"role":40,"phone":45,"phoneExt":32,"email":46},"Michele Sallaberger","+61 438471423","michele.sallaberger@florey.edu.au",[48,72,90,118,134,153,167],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Royal Prince Alfred Hospital","RECRUITING","Camperdown","New South Wales","2050","Australia","AU",{"type":57,"coordinates":58},"Point",[59,60],151.17642,-33.88965,{"lat":60,"lon":59},[63,66,69],{"name":64,"role":40,"phone":32,"phoneExt":32,"email":65},"Timothy Ang, Professor","Timothy.Ang@health.nsw.gov.au",{"name":67,"role":68,"phone":32,"phoneExt":32,"email":32},"Craig Anderson, Professor","PRINCIPAL_INVESTIGATOR",{"name":70,"role":71,"phone":32,"phoneExt":32,"email":32},"Timothy Ang, Dr","SUB_INVESTIGATOR",{"facility":73,"status":50,"city":74,"state":52,"zip":75,"country":54,"countryCode":55,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Liverpool Hospital","Liverpool","2170",{"type":57,"coordinates":77},[78,79],150.92588,-33.91938,{"lat":79,"lon":78},[82,85,86,88],{"name":83,"role":40,"phone":32,"phoneExt":32,"email":84},"Christopher Blair, Dr","christopher.blair@health.nsw.gov.au",{"name":83,"role":68,"phone":32,"phoneExt":32,"email":32},{"name":87,"role":71,"phone":32,"phoneExt":32,"email":32},"Mark Parsons, Professor",{"name":89,"role":71,"phone":32,"phoneExt":32,"email":32},"Dennis Cordato, A\u002FProfessor",{"facility":91,"status":50,"city":92,"state":52,"zip":93,"country":54,"countryCode":55,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"John Hunter Hospital","New Lambton Heights","2305",{"type":57,"coordinates":95},[96,97],151.69364,-32.92466,{"lat":97,"lon":96},[100,103,104,106,108,110,112,114,116],{"name":101,"role":40,"phone":32,"phoneExt":32,"email":102},"Chris Levi, Professor","Christopher.Levi@health.nsw.gov.au",{"name":101,"role":68,"phone":32,"phoneExt":32,"email":32},{"name":105,"role":71,"phone":32,"phoneExt":32,"email":32},"Carlos Garcia Esperon, Dr",{"name":107,"role":71,"phone":32,"phoneExt":32,"email":32},"Neil Spratt, Dr",{"name":109,"role":71,"phone":32,"phoneExt":32,"email":32},"Beng Lim Chew, Dr",{"name":111,"role":71,"phone":32,"phoneExt":32,"email":32},"James Thomas, Dr",{"name":113,"role":71,"phone":32,"phoneExt":32,"email":32},"Raka Datta, Dr",{"name":115,"role":71,"phone":32,"phoneExt":32,"email":32},"Delara Javat, Dr",{"name":117,"role":71,"phone":32,"phoneExt":32,"email":32},"Rajveer Singh, Dr",{"facility":119,"status":50,"city":120,"state":52,"zip":121,"country":54,"countryCode":55,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Prince of Wales Hospital","Randwick","2031",{"type":57,"coordinates":123},[124,125],151.24895,-33.91439,{"lat":125,"lon":124},[128,131,132],{"name":129,"role":40,"phone":32,"phoneExt":32,"email":130},"Ken Butcher, Professor","ken.butcher@unsw.edu.au",{"name":129,"role":68,"phone":32,"phoneExt":32,"email":32},{"name":133,"role":71,"phone":32,"phoneExt":32,"email":32},"Georgie Kerin, Dr",{"facility":135,"status":50,"city":136,"state":137,"zip":138,"country":54,"countryCode":55,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Royal Adelaide Hospital","Adelaide","South Australia","5000",{"type":57,"coordinates":140},[141,142],138.59863,-34.92866,{"lat":142,"lon":141},[145,148,149,151],{"name":146,"role":40,"phone":32,"phoneExt":32,"email":147},"Tim Kleinig, Professor","Timothy.Kleinig@sa.gov.au",{"name":146,"role":68,"phone":32,"phoneExt":32,"email":32},{"name":150,"role":71,"phone":32,"phoneExt":32,"email":32},"Joshua Mahadevan, Dr",{"name":152,"role":71,"phone":32,"phoneExt":32,"email":32},"Shaddy El-Masri, Dr",{"facility":154,"status":50,"city":155,"state":156,"zip":157,"country":54,"countryCode":55,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Eastern Health- Box Hill Hospital","Box Hill","Victoria","3128",{"type":57,"coordinates":159},[160,161],145.12545,-37.81887,{"lat":161,"lon":160},[164],{"name":165,"role":40,"phone":32,"phoneExt":32,"email":166},"Philip Choi","Philip.choi@monash.edu",{"facility":168,"status":50,"city":169,"state":156,"zip":170,"country":54,"countryCode":55,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Royal Melbourne Hospital","Parkville","3050",{"type":57,"coordinates":172},[173,174],144.95,-37.78333,{"lat":174,"lon":173},[177,180,181],{"name":178,"role":40,"phone":32,"phoneExt":32,"email":179},"Bruce Campbell, Professor","bruce.campbell@mh.org.au",{"name":178,"role":68,"phone":32,"phoneExt":32,"email":32},{"name":182,"role":71,"phone":32,"phoneExt":32,"email":32},"Vignan Yogendrakumar, Dr",{"type":184,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[186],{"name":187,"class":6},"Neuroscience Trials Australia","100467180","phase-2-safety-and-tolerability-of-adjunctive-tbo-309-in-reperfusion-for-stroke-100467180",false,"NCT05363397","Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke","STARS","Inclusion Criteria\n\n1. Patient aged 18 years or more\n2. Patient has an acute ischaemic stroke\n3. Patient will be treated with either:\n\n   1. Intravenous thrombolysis (IVT) with alteplase or tenecteplase for a diagnosis of AIS that is confirmed by CT imaging;\n\n      alone\u002FOR WITH\n   2. Endovascular Thrombectomy (EVT) for large vessel occlusion (LVO) in the internal carotid artery, middle cerebral artery (M1 segment), middle cerebral artery (M2 segment) or with tandem occlusion of both the cervical carotid and intracranial large arteries who either:\n\n   i. presented within 6 hours of stroke onset\n\n   OR\n\n   ii. presented between 6-24 hours after they were last known to be well and clinical observations and either CT perfusion or MRI features indicate the presence of salvageable brain tissue, defined as ischaemic core \\\u003C70mL with a mismatch ratio \\>1.8 and absolute mismatch \\>15mL.\n4. Patient has at least a mild grade of neurological impairment i.e. NIHSS of 5 or more\n5. Patient has an estimated pre-stroke mRS of less than 4\n\nExclusion Criteria\n\n1. Patient is considered unlikely to benefit from study intervention defined by one of the following:\n\n   1. Advanced dementia\n   2. Severe pre-stroke disability (mRS score 4-5)\n   3. Glasgow Coma Score (GCS) 3 to 5\n   4. Evidence of a large well-defined ischaemic lesion measuring more than one third of the MCA territory\n2. High likelihood of undergoing stent insertion and requiring additional antithrombotic(s)\n3. Uncontrolled hypertension (SBP \\>180 or DBP \\>110, refractory to medical therapy)\n4. ICH within the last 90 days\n5. Myocardial infarction or stroke within the last 30 days\n6. Patient has an underlying disease process with a life expectancy of \\\u003C90 days\n7. Contraindication to thrombolysis i.e. increased bleeding risk\n8. Contraindication to intravenous contrast agents including renal impairment or allergy\n9. Known treatment with dual antiplatelet therapy or anticoagulant medication\n10. Known severe liver disease\n11. Known bleeding disorder\n12. Cardiopulmonary resuscitation or arterial puncture at non-compressible site or lumbar puncture within 7 days\n13. Another medical illness or social circumstance that may interfere with outcome assessments and follow-up\n14. Known or suspected pregnancy\n15. Patients currently participating in another interventional clinical trial\n16. Informed consent unable to be obtained from the patient or their Person Responsible\u002FMedical Treatment Decision Maker prior to study interventions\n17. Study drug cannot be given within one hour of thrombolytic drug bolus","ALL","18 Years",{"count":198,"type":199},80,"ESTIMATED","INTERVENTIONAL",[202],"PHASE2","STARS is a prospective, multicentre, open-label, dose escalation, Phase IIa study to assess the safety and tolerability of TBO-309, an adjuvant antiplatelet therapy, in patients with AIS.\n\nAcute ischaemic stroke (AIS) is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain. Standard therapies target the blocked artery by either dissolving the blockage or removing the blockage. However, even after successful treatment, re-blockage of arteries can occur. The use of an antiplatelet therapy, TBO-309, in addition to standard therapies offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage.",[205],"Acute Ischemic Stroke",[207,208,209,210,211,29],"Antiplatelet therapy","Stroke","Blood clot","Intravenous thrombolysis (IVT)","Endovascular Thrombectomy (EVT)","2025-11-24",{"date":214,"type":215},"2025-12-01","ACTUAL",{"date":217,"type":215},"2023-09-27",{"date":219,"type":199},"2026-05-01",{"name":5,"class":6},7]