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

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)

NCT07115004•Vega Therapeutics, Inc

View on ClinicalTrials.gov

Summary

This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)

Detailed Description

This Phase 3 multicenter, open-label, single-sequence cross-over study will investigate the safety and efficacy of subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD. The study consists of an Observational Period of at least 24 weeks followed by an Active Treatment Period of approximately 49 weeks of VGA039 treatment. Bleeding data and details of treatments used will be collected from each patient during both study periods. The number, duration, location, and types of bleeds experienced, as well as treatments for bleeds, will be recorded in patient diaries. Adverse events will also be monitored and recorded throughout both study periods.

Eligibility

Age

12 - 75 years

Sex

ALL

Healthy Volunteers

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

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)

Locations (4)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Science 37, Inc. (Virtual Clinical MetaSite)

Morrisville, North Carolina, United States

Hemophilia Center of Western PA

Pittsburgh, Pennsylvania, United States

Washington Center for Bleeding Disorders

Seattle, Washington, United States

Key Dates

Start Date

October 15, 2025

Primary Completion Date

October 1, 2028

Completion Date

October 1, 2028

Last Updated

December 4, 2025

Enrollment

ESTIMATED participants

Conditions

Von Willebrand Disease (VWD)

Interventions

VGA039

DRUG

Contacts

Clinical Trials- Vega Therapeutics

CONTACT

650-466-8041 medinfo@star-therapeutics.com

A Study on the Outcomes of Recombinant Von Willebrand Factor on Demand Treatment and Prevention and Treatment of Bleeding During and After Surgery in Adults With Inherited Von Willebrand Disease in the United Kingdom (UK)

NCT06433778

Von Willebrand Disease (VWD)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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