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Study of VGA039 for Von Willebrand Disease (VIVID)

This study, called VIVID, is testing a new medication called VGA039 for people with Von Willebrand Disease (VWD), a bleeding disorder. It's also being tested in healthy volunteers. Researchers want to see if VGA039 is safe and how well your body tolerates it. Some participants will receive VGA039, while others will receive a placebo (an inactive substance). The study is looking for side effects and how often they occur. You might be able to join if you are between 12 and 60 years old, depending on the part of the study. The study aims to enroll 116 people. The current status of the study is unclear.

Study design
This is an interventional study with multiple parts, including randomized, double-blind, placebo-controlled sections and open-label sections. It involves healthy volunteers and individuals with Von Willebrand Disease, with a planned enrollment of 116 participants.
What's involved
Participants will receive single or multiple doses of VGA039 or placebo, given either intravenously (into a vein) or subcutaneously (under the skin). You will be followed up for 15 weeks after intravenous administration or 8 weeks after subcutaneous administration.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up for 15 weeks after intravenous study drug administration or 8 weeks after subcutaneous study drug administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05776069

Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)

Recruiting
PHASE1Ages 12–60InterventionalTreatment
Vega Therapeutics, Inc
~116 participants
Updated 2025-08-26 on ClinicalTrials.gov
What's tested:VGA039Placebo

At a glance

Recruiting sites
24 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Measured over From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively

Conditions

Von Willebrand Diseases

Explore related trials

Bleeding Diathesisvon Willebrand Disease

Where it's being run

25 sites across 20 states
Ontario3
California2
São Paulo2
London2
Colorado1
Georgia1
North Carolina1
Pennsylvania1

Who to contact

Clinical Trials
[email protected]
650-466-8041
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
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.

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively

    Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), including dose-limiting toxicities (DLTs).