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Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)
RecruitingPhase 3
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)
Who can join
Ages 12 to 75 · All sexes
Full eligibility criteria
Key Inclusion Criteria * 12 to 75 years of age, inclusive * No clinically significant laboratory, ECG, or vital signs results * Documented diagnosis consistent with VWD of any type * Historical annualized bleeding rate (ABR; excluding menstrual bleeds and bleeds under the skin) of both untreated and treated bleeds ≥12 per year * Patients with VWD who are judged by the investigator to be suitable candidates for routine prophylaxis to reduce the frequency of bleeding episodes * Hemoglobin level ≥ 8 g/dL and platelet count ≥ 100 x 109/L at Screening Key Exclusion Criteria * 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 * Planning to initiate routine prophylaxis with VWF-containing concentrates or any other hemostatic treatment during the study * Patients with pro-thrombotic disorders or abnormal findings on laboratory thrombophilia evaluation performed at screening or previously documented * History of arterial or venous thrombosis, including superficial thrombophlebitis, or embolism * Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, or metabolic dysfunction * Baseline FVIII activity \> lower limit of normal (LLN)
About the study
This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)
What is being tested
- VGA039 (drug)
Sponsor: Vega Therapeutics, Inc · Participants: 60 · Started: Oct 15, 2025
Contact the study team
- Clinical Trials- Vega Therapeutics · Phone: 650-466-8041
Official record on ClinicalTrials.gov — NCT07115004
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.