[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vega Therapeutics, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100601785",false,"NCT07115004","Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)","A Prospective, Multicenter, Open-label, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Prophylactic VGA039 in Adolescent and Adult Patients With Von Willebrand Disease (VIVID-6)","VIVID-6","Key Inclusion Criteria\n\n* 12 to 75 years of age, inclusive\n* No clinically significant laboratory, ECG, or vital signs results\n* Documented diagnosis consistent with VWD of any type\n* Historical annualized bleeding rate (ABR; excluding menstrual bleeds and bleeds under the skin) of both untreated and treated bleeds ≥12 per year\n* Patients with VWD who are judged by the investigator to be suitable candidates for routine prophylaxis to reduce the frequency of bleeding episodes\n* Hemoglobin level ≥ 8 g\u002FdL and platelet count ≥ 100 x 109\u002FL at Screening\n\nKey Exclusion Criteria\n\n* Use of routine prophylaxis of VWF-containing concentrates defined as at least 1 VWF-containing concentrate infusion to prevent or reduce bleeding per week during the previous 6 months prior to screening\n* Planning to initiate routine prophylaxis with VWF-containing concentrates or any other hemostatic treatment during the study\n* Patients with pro-thrombotic disorders or abnormal findings on laboratory thrombophilia evaluation performed at screening or previously documented\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* Baseline FVIII activity \\> lower limit of normal (LLN)","ALL","12 Years","75 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)",[27],"Von Willebrand Disease (VWD)",[29,30,14,31,32,33],"VWD","von Willebrand Disease","Vega Therapeutics","Star Therapeutics","VGA039","RECRUITING","2026-04-02",{"date":37,"type":38},"2026-04-03","ACTUAL",{"date":40,"type":38},"2025-10-15",{"date":42,"type":21},"2028-10",{"name":44,"class":45},"Vega Therapeutics, Inc","INDUSTRY",14,{"id":48,"slug":4,"hasResults":10,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100498885","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,"60 Years",{"count":56,"type":21},116,[58,59],"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.",[62],"Von Willebrand Diseases",[64,29,32,31,65,66,67,68,69,70,33,71],"Von Willebrand Disorder","VIVID","VIVID-1","VIVID-2","VIVID-3","VIVID-5","Bleeding disorders","Blood coagulation disorders","2025-08-19",{"date":74,"type":38},"2025-08-26",{"date":76,"type":38},"2023-03-16",{"date":78,"type":21},"2029-12",{"name":44,"class":45},25,""]