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 (14) 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
California
Luskin Orthopaedic Institute For Children
RECRUITING
Los Angeles
UC Davis Medical Center
RECRUITING
Sacramento
University of California San Francisco
RECRUITING
San Francisco
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Emory University Hospital
RECRUITING
Atlanta
Minnesota
University of Minnesota
RECRUITING
Minneapolis
North Carolina
Science 37, Inc. (Virtual Clinical MetaSite)
RECRUITING
Morrisville
Pennsylvania
Hemophilia Center of Western PA
RECRUITING
Pittsburgh
Texas
UT Southwestern Children's Hospital
RECRUITING
Dallas
Washington
Washington Center for Bleeding Disorders
RECRUITING
Seattle
Other Locations
Georgia
K Eristavi National Center of Experimental and Clinical Surgery (ქირურგიის ეროვნული ცენტრი)
RECRUITING
Tbilisi
Germany
Frankfurt University Hospital (Universitätsmedizin Frankfurt)
RECRUITING
Frankfurt
South Africa
Charlotte Maxeke Johannesburg Academic Hospital School of Pathology Clinical Haematologist
RECRUITING
Johannesburg
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