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Study of VGA039 for Von Willebrand Disease

This study is testing a new medication called VGA039, given under the skin (subcutaneous or SC), for people with Von Willebrand Disease (VWD). VWD is a bleeding disorder where your blood doesn't clot properly. The study aims to see how safe and effective VGA039 is at preventing bleeding episodes. You might be able to join if you are between 12 and 75 years old, have a confirmed diagnosis of VWD, and have experienced at least 12 bleeding events per year in the past. The main goal is to count how many bleeding events occur during the 49 weeks you receive VGA039. The current recruitment status is unclear.

Study design
This is a Phase 3, open-label study with about 60 participants. It involves an observational period followed by a treatment period.
What's involved
You would first have an observational period of at least 24 weeks, followed by about 49 weeks of receiving VGA039. You would keep a diary to record bleeding events and treatments, and adverse events would be monitored.
Compensation
Not stated in the trial record.
Follow-up
Bleeding events will be measured for 49 weeks after starting VGA039.

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

NCT07115004

Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)

Recruiting
PHASE3Ages 12–75InterventionalTreatment
Vega Therapeutics, Inc
~60 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:VGA039

At a glance

Recruiting sites
32 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of bleeding events [Efficacy]
Measured over Time Frame: From 7 days after informed consent until 49 weeks after SC study drug initiation

Conditions

Von Willebrand Disease (VWD)

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NCT07115004

Where you'd take part

This study runs at 32 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Emory University Hospital

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Science 37, Inc. (Virtual Clinical MetaSite)

    Morrisville, North Carolinastudy coordinator listed

    Recruiting

  • Washington Center for Bleeding Disorders

    Seattle, Washingtonstudy coordinator listed

    Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansasno site contact published

    Recruiting

  • Azienda Ospedaliero-Universitaria Careggi (Careggi University Hospital)

    Florence, Italyno site contact published

    Recruiting

  • Centro de Hemoterapia e Hematologia do Rio de Janeiro (HEMORIO)

    Rio de Janeiro, Rio de Janeiro, Brazilno site contact published

    Recruiting

  • Charlotte Maxeke Johannesburg Academic Hospital School of Pathology Clinical Haematologist

    Johannesburg, South Africano site contact published

    Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

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

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Eligibility criteria

Inclusion

12 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

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)

What this trial measures

  • Incidence of bleeding events [Efficacy]Time Frame: From 7 days after informed consent until 49 weeks after SC study drug initiation