VGA039 for Von Willebrand Disease
(VIVID-6 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of a new treatment called VGA039, an experimental therapy for individuals with von Willebrand Disease (VWD), a condition that affects blood clotting and causes frequent bleeding episodes. Participants will undergo a 24-week observation period before receiving VGA039 injections for about 49 weeks. The trial seeks individuals with a documented diagnosis of VWD who experience frequent bleeding episodes (12 or more per year, excluding menstrual and under-the-skin bleeds). As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that VGA039 is likely to be safe for humans?
Research has shown that VGA039 is generally safe. In earlier studies, healthy volunteers tolerated VGA039 well, experiencing no major side effects. Reports also indicate that an injection of VGA039 under the skin reduced bleeding episodes in patients with von Willebrand Disease (VWD).
Although past studies haven't reported any serious side effects, staying informed and discussing any concerns with a doctor is always important.12345Why do researchers think this study treatment might be promising?
Unlike the standard of care for Von Willebrand Disease, which often includes replacement therapies or desmopressin, VGA039 is a novel treatment administered subcutaneously. Researchers are excited about VGA039 because it offers a more convenient delivery method compared to traditional intravenous infusions. Additionally, VGA039 may provide a new mechanism of action, potentially targeting the disease more effectively and improving patient outcomes over a longer period. This makes VGA039 a promising advance in the treatment of Von Willebrand Disease.
What evidence suggests that VGA039 might be an effective treatment for Von Willebrand Disease?
Research shows that VGA039 might help people with von Willebrand Disease (VWD) by reducing bleeding. In earlier studies, patients who received VGA039 experienced 75% to 88% fewer bleeding episodes annually, meaning they bled less often over a year. In this trial, participants who meet eligibility criteria and complete a 24-week observational phase will receive VGA039 as a simple shot under the skin for approximately 49 weeks. Early results suggest that VGA039 could be a promising way to manage VWD symptoms.12367
Are You a Good Fit for This Trial?
This trial is for people aged 12-75 with Von Willebrand Disease who have a history of frequent bleeding episodes (excluding menstrual and skin bleeds) and are not already on weekly preventive treatments. Participants must have stable vital signs, normal hemoglobin levels, and platelet counts. Those with clotting disorders, past thrombosis, or significant organ disease cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observational Period
Participants are observed for bleeding events and treatments are recorded
Active Treatment
Participants receive VGA039 SC for prophylaxis of bleeding
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VGA039
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vega Therapeutics, Inc
Lead Sponsor