A Phase 3 Study to Evaluate the Safety and Effectiveness of Subcutaneous VGA039 as Preventive Treatment for Bleeding in Adolescents and Adults with Von Willebrand Disease (VIVID-6)

What this Trial Is About

Researchers are evaluating subcutaneous VGA039 as a preventive treatment for bleeding in patients with all types of von Willebrand Disease (VWD) in this Phase 3, open-label, multicenter study. The study aims to assess the safety and effectiveness of VGA039 administered under the skin for reducing bleeding episodes in adolescents and adults aged 12 to 75 years who have a history of frequent bleeds. This research is sponsored by Vega Therapeutics, Inc. The study includes two main periods. First, there is an observational phase lasting at least 24 weeks during which bleeding events and treatments are recorded without intervention. After this, eligible patients receive VGA039 subcutaneously for about 49 weeks. During the treatment phase, participants continue to track bleeding episodes, their duration, location, and treatments used in diaries. Researchers monitor adverse events throughout both study periods. Participants will be involved in regular monitoring and will keep detailed records of bleeding episodes and treatments throughout the study. Safety assessments include tracking any side effects or adverse reactions during the entire duration. The primary outcome measured is the frequency of bleeding events from one week after consent through 49 weeks of treatment. Secondary outcomes include treated bleeding events, safety assessments for adverse events, drug levels in the blood, and immune responses to VGA039. Total participation spans approximately 73 weeks including observation and treatment.

Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)