[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498885":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":31,"centralContacts":46,"locations":52,"responsibleParty":303,"collaborators":31,"id":305,"slug":31,"hasResults":306,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":31,"eligibilityCriteria":310,"healthyVolunteers":311,"sex":312,"minAge":313,"maxAge":314,"enrollmentInfo":315,"targetDuration":31,"studyType":318,"phases":319,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":55,"whyStopped":31,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":346},{"fullName":5,"class":6},"Vega Therapeutics, Inc","INDUSTRY",[8,15,20,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1","PLACEBO_COMPARATOR","Cohorts 1-8 IV or SC VGA039 or Placebo dose to be determined",[13,14],"Drug: VGA039","Other: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Part 2","EXPERIMENTAL","Cohorts A-H IV or SC VGA039 dose to be determined",[13],{"label":21,"type":17,"description":22,"interventionNames":23},"Part 3","Cohorts MD-1 to MD-4, SC VGA039 multiple doses, dose to be determined",[13],{"label":25,"type":17,"description":26,"interventionNames":27},"Part 4","Cohorts of VGA039 single dose for surgical prophylaxis",[13],{"label":29,"type":17,"description":30,"interventionNames":31},"Part 5","Multiple doses of VGA039 in open label extension",null,[33,38,43],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":31},"DRUG","VGA039","Single doses of VGA039",[9,16,25],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":31},"OTHER","Placebo","Single doses of Placebo",[9],{"type":34,"name":35,"description":44,"armGroupLabels":45,"otherNames":31},"Multiple doses of VGA039",[21],[47],{"name":48,"role":49,"phone":50,"phoneExt":31,"email":51},"Clinical Trials","CONTACT","650-466-8041","medinfo@star-therapeutics.com",[53,66,75,85,95,110,120,130,140,150,160,171,182,192,202,210,221,230,239,250,259,270,280,289,298],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":31},"Orthopedic Institute for Children (UCLA)","RECRUITING","Los Angeles","California","90007","United States",{"type":61,"coordinates":62},"Point",[63,64],-118.24368,34.05223,{"lat":64,"lon":63},{"facility":67,"status":55,"city":68,"state":57,"zip":69,"country":59,"cosmosGeoPoint":70,"geoPoint":74,"contacts":31},"UC Davis Medical Center","Sacramento","95817",{"type":61,"coordinates":71},[72,73],-121.4944,38.58157,{"lat":73,"lon":72},{"facility":76,"status":55,"city":77,"state":78,"zip":79,"country":59,"cosmosGeoPoint":80,"geoPoint":84,"contacts":31},"University of Colorado School of Medicine","Aurora","Colorado","80045",{"type":61,"coordinates":81},[82,83],-104.83192,39.72943,{"lat":83,"lon":82},{"facility":86,"status":55,"city":87,"state":88,"zip":89,"country":59,"cosmosGeoPoint":90,"geoPoint":94,"contacts":31},"Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory","Atlanta","Georgia","30308",{"type":61,"coordinates":91},[92,93],-84.38798,33.749,{"lat":93,"lon":92},{"facility":96,"status":55,"city":97,"state":98,"zip":99,"country":59,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Science 37, Inc.","Morrisville","North Carolina","27560",{"type":61,"coordinates":101},[102,103],-78.82556,35.82348,{"lat":103,"lon":102},[106],{"name":107,"role":49,"phone":108,"phoneExt":31,"email":109},"Science 37 Recruitment Team","984-377-3737","recruitment@science37.com",{"facility":111,"status":55,"city":112,"state":113,"zip":114,"country":59,"cosmosGeoPoint":115,"geoPoint":119,"contacts":31},"Hemophilia Center of Western PA","Pittsburgh","Pennsylvania","15213",{"type":61,"coordinates":116},[117,118],-79.99589,40.44062,{"lat":118,"lon":117},{"facility":121,"status":55,"city":122,"state":123,"zip":124,"country":59,"cosmosGeoPoint":125,"geoPoint":129,"contacts":31},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":61,"coordinates":126},[127,128],-86.78444,36.16589,{"lat":128,"lon":127},{"facility":131,"status":55,"city":132,"state":133,"zip":134,"country":59,"cosmosGeoPoint":135,"geoPoint":139,"contacts":31},"University of Texas Southwestern","Dallas","Texas","75235",{"type":61,"coordinates":136},[137,138],-96.80667,32.78306,{"lat":138,"lon":137},{"facility":141,"status":55,"city":142,"state":143,"zip":144,"country":59,"cosmosGeoPoint":145,"geoPoint":149,"contacts":31},"Washington Center for Bleeding Disorders","Seattle","Washington","98101",{"type":61,"coordinates":146},[147,148],-122.33207,47.60621,{"lat":148,"lon":147},{"facility":151,"status":55,"city":152,"state":153,"zip":154,"country":59,"cosmosGeoPoint":155,"geoPoint":159,"contacts":31},"Versiti Comprehensive Center for Bleeding Disorders","Milwaukee","Wisconsin","53233",{"type":61,"coordinates":156},[157,158],-87.90647,43.0389,{"lat":158,"lon":157},{"facility":161,"status":55,"city":162,"state":163,"zip":164,"country":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":31},"Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre","Herston","Queenland","4029","Australia",{"type":61,"coordinates":167},[168,169],153.01852,-27.44453,{"lat":169,"lon":168},{"facility":172,"status":173,"city":174,"state":175,"zip":31,"country":176,"cosmosGeoPoint":177,"geoPoint":181,"contacts":31},"Medical University of Vienna","COMPLETED","Vienna","State of Vienna","Austria",{"type":61,"coordinates":178},[179,180],16.37208,48.20849,{"lat":180,"lon":179},{"facility":183,"status":55,"city":184,"state":184,"zip":185,"country":186,"cosmosGeoPoint":187,"geoPoint":191,"contacts":31},"Centro de Hemoterapia e Hematologia do Rio de Janeiro HEMORIO","Rio de Janeiro","20211-030","Brazil",{"type":61,"coordinates":188},[189,190],-43.18223,-22.90642,{"lat":190,"lon":189},{"facility":193,"status":55,"city":194,"state":195,"zip":196,"country":186,"cosmosGeoPoint":197,"geoPoint":201,"contacts":31},"Hemocentro Unicamp","Campinas","São Paulo","13083-878",{"type":61,"coordinates":198},[199,200],-47.06083,-22.90556,{"lat":200,"lon":199},{"facility":203,"status":55,"city":195,"state":195,"zip":204,"country":186,"cosmosGeoPoint":205,"geoPoint":209,"contacts":31},"Hospital das Clinicas - USP Endereco","05403-010",{"type":61,"coordinates":206},[207,208],-46.63611,-23.5475,{"lat":208,"lon":207},{"facility":211,"status":55,"city":212,"state":213,"zip":214,"country":215,"cosmosGeoPoint":216,"geoPoint":220,"contacts":31},"Hamilton Health Sciences Corporation","Hamilton","Ontario","L8N 3Z5","Canada",{"type":61,"coordinates":217},[218,219],-79.84963,43.25011,{"lat":219,"lon":218},{"facility":222,"status":55,"city":223,"state":213,"zip":224,"country":215,"cosmosGeoPoint":225,"geoPoint":229,"contacts":31},"Queens University","Kingston","K7L 3N6",{"type":61,"coordinates":226},[227,228],-76.48098,44.22976,{"lat":228,"lon":227},{"facility":231,"status":55,"city":232,"state":213,"zip":233,"country":215,"cosmosGeoPoint":234,"geoPoint":238,"contacts":31},"St. Michaels Hospital","Toronto","M5B 1W8",{"type":61,"coordinates":235},[236,237],-79.39864,43.70643,{"lat":237,"lon":236},{"facility":240,"status":55,"city":241,"state":242,"zip":243,"country":244,"cosmosGeoPoint":245,"geoPoint":249,"contacts":31},"K J Somaiya Super Speciality Hospital & Research Centre","Sion","Mumbai","400022","India",{"type":61,"coordinates":246},[247,248],83.07157,25.37394,{"lat":248,"lon":247},{"facility":251,"status":55,"city":252,"state":31,"zip":31,"country":253,"cosmosGeoPoint":254,"geoPoint":258,"contacts":31},"Charlotte Maxeke Johannesburg Academic Hospital","Johannesburg","South Africa",{"type":61,"coordinates":255},[256,257],28.04363,-26.20227,{"lat":257,"lon":256},{"facility":260,"status":55,"city":261,"state":262,"zip":263,"country":264,"cosmosGeoPoint":265,"geoPoint":269,"contacts":31},"Queen Elizabeth Hospital Birmingham","Birmingham","Edgbaston","B15 2TT","United Kingdom",{"type":61,"coordinates":266},[267,268],-1.89983,52.48142,{"lat":268,"lon":267},{"facility":271,"status":55,"city":272,"state":273,"zip":274,"country":264,"cosmosGeoPoint":275,"geoPoint":279,"contacts":31},"University Hospital Southampton NHS Foundation Trust","Southampton","Hampshire","SO16 6YD.",{"type":61,"coordinates":276},[277,278],-1.40428,50.90395,{"lat":278,"lon":277},{"facility":281,"status":55,"city":282,"state":282,"zip":283,"country":264,"cosmosGeoPoint":284,"geoPoint":288,"contacts":31},"Royal Free Hospital","London","NW3 2QG",{"type":61,"coordinates":285},[286,287],-0.12574,51.50853,{"lat":287,"lon":286},{"facility":290,"status":55,"city":291,"state":282,"zip":292,"country":264,"cosmosGeoPoint":293,"geoPoint":297,"contacts":31},"Royal London Hospital, Clinical Haematology Research","Whitechapel","E12ES",{"type":61,"coordinates":294},[295,296],-0.06583,51.51382,{"lat":296,"lon":295},{"facility":299,"status":55,"city":282,"state":31,"zip":31,"country":264,"cosmosGeoPoint":300,"geoPoint":302,"contacts":31},"Imperial College Healthcare NHS Trust- Queen Charlotte's & Chelsea Hospital",{"type":61,"coordinates":301},[286,287],{"lat":287,"lon":286},{"type":304,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100498885",false,"NCT05776069","Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)","A Multi-Modular Trial to Evaluate VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease and Other Bleeding Disorders (VIVID)","Key Inclusion Criteria (All Subjects)\n\n* Subjects, 18 to 60 years of age, inclusive for Parts 1 and 2\n* Subjects, 12 to 60 years of age, inclusive for Parts 3 and 5\n* No clinically significant laboratory, ECG, or vital signs results.\n\nAdditional Key Inclusion Criteria (for Subjects in Part 1 Only) • Body mass index of 18-32 kg\u002Fm2\n\nAdditional Key Inclusion Criteria (for Subjects in Part 2 Only)\n\n* Subjects with VWD who are symptomatic, defined as having a history of bleeding or bruising.\n* Hemoglobin level ≥ 8 g\u002FdL and platelet count ≥ 150 × 109\u002FL at Screening.\n\nExclusion Key Criteria (All Subjects)\n\n* Use of hormonal contraceptives within 56 days prior to administration of the study drug.\n* Subjects with detection of FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening.\n* Subjects with other known pro-thrombotic disorders or abnormal findings in any prior laboratory thrombophilia evaluation.\n* History of arterial or venous thrombosis, including superficial thrombophlebitis, or embolism.\n* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, or metabolic dysfunction.\n\nAdditional Key Exclusion Criterion (Subjects in Part 1 Only)\n\n• Baseline FVIII activity \\> 150 IU\u002FdL.\n\nAdditional Key Exclusion Criteria (Subjects in Parts 2, 3, 4 and 5 Only)\n\n* Baseline FVIII activity \\> 50 IU\u002FdL.\n* Any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.",true,"ALL","12 Years","60 Years",{"count":316,"type":317},116,"ESTIMATED","INTERVENTIONAL",[320,321],"PHASE1","PHASE2","The VIVID study is structured in a master protocol format comprised of multiple parts that evaluate intravenous (IV) and subcutaneous (SC) VGA039 in healthy volunteers and subjects with von Willebrand Disease (VWD) and other bleeding disorders.",[324],"Von Willebrand Diseases",[326,327,328,329,330,331,332,333,334,335,35,336],"Von Willebrand Disorder","VWD","Star Therapeutics","Vega Therapeutics","VIVID","VIVID-1","VIVID-2","VIVID-3","VIVID-5","Bleeding disorders","Blood coagulation disorders","2025-08-19",{"date":339,"type":340},"2025-08-26","ACTUAL",{"date":342,"type":340},"2023-03-16",{"date":344,"type":317},"2029-12",{"name":5,"class":6},25]