Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)
NCT ID: NCT05776069
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
116 participants
INTERVENTIONAL
2023-03-16
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Part 1
Cohorts 1-8 IV or SC VGA039 or Placebo dose to be determined
VGA039
Single doses of VGA039
Placebo
Single doses of Placebo
Part 2
Cohorts A-H IV or SC VGA039 dose to be determined
VGA039
Single doses of VGA039
Part 3
Cohorts MD-1 to MD-4, SC VGA039 multiple doses, dose to be determined
VGA039
Multiple doses of VGA039
Part 4
Cohorts of VGA039 single dose for surgical prophylaxis
VGA039
Single doses of VGA039
Part 5
Multiple doses of VGA039 in open label extension
No interventions assigned to this group
Interventions
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VGA039
Single doses of VGA039
Placebo
Single doses of Placebo
VGA039
Multiple doses of VGA039
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.
12 Years
60 Years
ALL
Yes
Sponsors
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Vega Therapeutics, Inc
INDUSTRY
Responsible Party
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Locations
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Orthopedic Institute for Children (UCLA)
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
University of Colorado School of Medicine
Aurora, Colorado, United States
Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory
Atlanta, Georgia, United States
Science 37, Inc.
Morrisville, North Carolina, United States
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Washington Center for Bleeding Disorders
Seattle, Washington, United States
Versiti Comprehensive Center for Bleeding Disorders
Milwaukee, Wisconsin, United States
Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre
Herston, Queenland, Australia
Medical University of Vienna
Vienna, Vienna, Austria
Centro de Hemoterapia e Hematologia do Rio de Janeiro HEMORIO
Rio de Janeiro, Rio de Janeiro, Brazil
Hemocentro Unicamp
Campinas, São Paulo, Brazil
Hospital das Clinicas - USP Endereco
São Paulo, São Paulo, Brazil
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Queens University
Kingston, Ontario, Canada
St. Michaels Hospital
Toronto, Ontario, Canada
K J Somaiya Super Speciality Hospital & Research Centre
Sion, Mumbai, India
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, , South Africa
Queen Elizabeth Hospital Birmingham
Birmingham, Edgbaston, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Royal Free Hospital
London, London, United Kingdom
Royal London Hospital, Clinical Haematology Research
Whitechapel, London, United Kingdom
Imperial College Healthcare NHS Trust- Queen Charlotte's & Chelsea Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VGA039-CP001
Identifier Type: -
Identifier Source: org_study_id
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