[{"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:":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100601785","phase-3-study-to-evaluate-subcutaneous-sc-vga039-in-patients-with-von-willebrand-disease-vwd-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":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)",[28],"Von Willebrand Disease (VWD)",[30,31,15,32,33,34],"VWD","von Willebrand Disease","Vega Therapeutics","Star Therapeutics","VGA039","RECRUITING","2026-04-02",{"date":38,"type":39},"2026-04-03","ACTUAL",{"date":41,"type":39},"2025-10-15",{"date":43,"type":22},"2028-10",{"name":45,"class":46},"Vega Therapeutics, Inc","INDUSTRY",14,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100498885","phase-1-study-of-vga039-in-healthy-volunteers-and-patients-with-von-willebrand-disease-vivid-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":58,"type":22},116,[60,61],"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.",[64],"Von Willebrand Diseases",[66,30,33,32,67,68,69,70,71,72,34,73],"Von Willebrand Disorder","VIVID","VIVID-1","VIVID-2","VIVID-3","VIVID-5","Bleeding disorders","Blood coagulation disorders","2025-08-19",{"date":76,"type":39},"2025-08-26",{"date":78,"type":39},"2023-03-16",{"date":80,"type":22},"2029-12",{"name":45,"class":46},25,""]