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 location...
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
North Carolina
Science 37, Inc. (Virtual Clinical MetaSite)
RECRUITING
Morrisville
Contact Information
Primary
Clinical Trials- Vega Therapeutics
medinfo@star-therapeutics.com
650-466-8041
Time Frame
Start Date: 2025-09-01
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