RecruitingPhase 3NCT07115004
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)
Sponsor
Vega Therapeutics, Inc
Enrollment
60 participants
Start Date
Oct 15, 2025
Study Type
INTERVENTIONAL
Summary
This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)
Eligibility
Min Age: 12 YearsMax Age: 75 Years
Inclusion Criteria6
- 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
Exclusion Criteria6
- 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)
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Interventions
DRUGVGA039
VGA039 SC administered for 49-weeks during the interventional phase following a 24-week observational period.
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT07115004