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)
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
North Carolina
Science 37, Inc. (Virtual Clinical MetaSite)
RECRUITING
Morrisville
Pennsylvania
Hemophilia Center of Western PA
RECRUITING
Pittsburgh
Washington
Washington Center for Bleeding Disorders
RECRUITING
Seattle
Contact Information
Primary
Clinical Trials- Vega Therapeutics
medinfo@star-therapeutics.com
650-466-8041
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2028-10
Participants
Target number of participants: 60
Treatments
Experimental: Multiple Doses of VGA039 after observational run-in
Participants who meet eligibility criteria and complete a 24-week observational phase will receive VGA039 SC for approximately 49 weeks.
Related Therapeutic Areas
Sponsors
Leads: Vega Therapeutics, Inc