Study of VGA039 in Healthy Volunteers and Patients with Von Willebrand Disease (VIVID)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria (All Subjects)
- Subjects, 18 to 60 years of age, inclusive for Parts 1 and 2
- Subjects, 12 to 60 years of age, inclusive for Parts 3 and 5
- No clinically significant laboratory, ECG, or vital signs results.
Additional Key Inclusion Criteria (for Subjects in Part 1 Only) • Body mass index of 18-32 kg/m2
Additional Key Inclusion Criteria (for Subjects in Part 2 Only)
- Subjects with VWD who are symptomatic, defined as having a history of bleeding or bruising.
- Hemoglobin level ≥ 8 g/dL and platelet count ≥ 150 × 109/L at Screening.
Exclusion Key Criteria (All Subjects)
- Use of hormonal contraceptives within 56 days prior to administration of the study drug.
- Subjects with detection of FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening.
- Subjects with other known pro-thrombotic disorders or abnormal findings in any prior laboratory thrombophilia evaluation.
- 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.
Additional Key Exclusion Criterion (Subjects in Part 1 Only)
• Baseline FVIII activity > 150 IU/dL.
EXCLUSION CRITERIA
Additional Key Exclusion Criteria (Subjects in Parts 2, 3, 4 and 5 Only)
- Baseline FVIII activity > 50 IU/dL.
- Any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.

Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Von Willebrand Diseases
Age
12 - 60
Phase
PHASE1/PHASE2
Participants Needed
116
Est. Completion Date
Dec 31, 2029
Treatment Type
INTERVENTIONAL
Sponsor
Vega Therapeutics, Inc
ClinicalTrials.gov NCT Identifier
NCT05776069
Study Number
VGA039-CP001
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