RecruitingPhase 1Phase 2NCT05776069
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)
Sponsor
Vega Therapeutics, Inc
Enrollment
116 participants
Start Date
Mar 16, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 12 YearsMax Age: 60 Years
Inclusion Criteria13
- 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.
- 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 Criteria2
- 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.
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Interventions
DRUGVGA039
Single doses of VGA039
OTHERPlacebo
Single doses of Placebo
DRUGVGA039
Multiple doses of VGA039
Locations(25)
View Full Details on ClinicalTrials.gov
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NCT05776069
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