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

RecruitingPhase 3

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)

Who can join

Ages 12 to 75 · All sexes

Full eligibility criteria
Key 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

Key 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)

About the study

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

What is being tested

Sponsor: Vega Therapeutics, Inc · Participants: 60 · Started: Oct 15, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07115004

Locations in the U.S.

ArkansasArkansas Children's Hospital, Little Rock
CaliforniaLuskin Orthopaedic Institute For Children, Los Angeles
Stanford University, Palo Alto
UC Davis Medical Center, Sacramento
University of California San Francisco, San Francisco
ConnecticutYale University School of Medicine, New Haven
GeorgiaChildren's Healthcare of Atlanta, Atlanta
Emory University Hospital, Atlanta
MichiganUniversity of Michigan Health, Ann Arbor
MinnesotaUniversity of Minnesota, Minneapolis
North CarolinaScience 37, Inc. (Virtual Clinical MetaSite), Morrisville
PennsylvaniaHemophilia Center of Western PA, Pittsburgh
TexasUT Southwestern Children's Hospital, Dallas
WashingtonWashington Center for Bleeding Disorders, Seattle

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.