Subcutaneous VGA039 to prevent bleeds in people with von Willebrand disease
A Prospective, Multicenter, Open-label, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Prophylactic VGA039 in Adolescent and Adult Patients With Von Willebrand Disease (VIVID-6)
This study will test whether subcutaneous VGA039 can reduce bleeding in people aged 12–75 with any type of von Willebrand disease who have frequent bleeds.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years to 75 Years |
| Sex | All |
| Sponsor | Vega Therapeutics, Inc Industry-sponsored |
| Locations | 14 sites (Little Rock, Arkansas and 13 other locations) |
| Trial ID | NCT07115004 on ClinicalTrials.gov |
What this trial studies
This is a Phase 3, multicenter, open-label, single-sequence crossover study that gives each participant an observational period followed by active treatment with subcutaneous VGA039. After at least 24 weeks of observational data collection, participants will receive approximately 49 weeks of VGA039 prophylaxis. Patients will keep diaries recording the number, duration, location, and type of bleeds and any treatments used, while investigators monitor adverse events and laboratory findings. The study enrolls people with all types of VWD who have a high historical bleeding rate and are considered candidates for routine prophylaxis.
Who should consider this trial
Good fit: Ideal candidates are people aged 12–75 with a documented diagnosis of any type of VWD, a historical annualized bleeding rate ≥12 (excluding menstrual and subcutaneous bleeds), hemoglobin ≥8 g/dL, platelet count ≥100×10^9/L, and who are judged suitable for routine prophylaxis but are not currently on frequent VWF concentrate prophylaxis.
Not a fit: Patients unlikely to receive benefit include those with low bleeding rates, those already using routine weekly prophylaxis with VWF-containing concentrates, people with pro-thrombotic disorders or abnormal thrombophilia testing, or those planning to start other routine hemostatic prophylaxis during the study.
Why it matters
Potential benefit: If successful, VGA039 could reduce the frequency and severity of bleeds and lessen reliance on intravenous VWF concentrates, making prophylaxis more convenient for patients.
How similar studies have performed: Earlier clinical work of VGA039 and related subcutaneous VWF approaches generated sufficient safety and bleeding-control signals to proceed to Phase 3, but broader confirmation in large trials is still needed.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria * 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 Key Exclusion Criteria * 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)
Where this trial is running
Little Rock, Arkansas and 13 other locations
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (Recruiting)
- Luskin Orthopaedic Institute For Children — Los Angeles, California, United States (Recruiting)
- UC Davis Medical Center — Sacramento, California, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Science 37, Inc. (Virtual Clinical MetaSite) — Morrisville, North Carolina, United States (Recruiting)
- Hemophilia Center of Western PA — Pittsburgh, Pennsylvania, United States (Recruiting)
- UT Southwestern Children's Hospital — Dallas, Texas, United States (Recruiting)
- Washington Center for Bleeding Disorders — Seattle, Washington, United States (Recruiting)
- K Eristavi National Center of Experimental and Clinical Surgery (ქირურგიის ეროვნული ცენტრი) — Tbilisi, Georgia (Recruiting)
- Frankfurt University Hospital (Universitätsmedizin Frankfurt) — Frankfurt, Germany (Recruiting)
- Charlotte Maxeke Johannesburg Academic Hospital School of Pathology Clinical Haematologist — Johannesburg, South Africa (Recruiting)
Study contacts
- Study coordinator: Clinical Trials- Vega Therapeutics
- Email: medinfo@star-therapeutics.com
- Phone: 650-466-8041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.