Recruiting

VIVID-6VGA039 Prophylaxis for Von Willebrand Disease in Adolescents and Adults

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What is being tested

VGA039

Drug
Who is being recruted

Blood Coagulation Disorders+7

+ Blood Platelet Disorders

+ Hematologic Diseases

From 12 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorVega Therapeutics, Inc
Study ContactClinical Trials- Vega Therapeutics
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 15, 2025

Actual date on which the first participant was enrolled.

This clinical study is designed to assess how well a new treatment, VGA039, works in preventing bleeding episodes in adolescents and adults who have Von Willebrand Disease (VWD), a genetic disorder that affects the blood's ability to clot. The study aims to see if VGA039, given as a subcutaneous injection, can reduce the frequency and severity of bleeding. This research is important because VWD can lead to frequent and serious bleeding problems, and finding effective treatments can significantly improve the quality of life for those affected. Participants in the study will first go through an observational period of at least 24 weeks, where their bleeding patterns and treatments are documented. This is followed by about 49 weeks where they will receive regular injections of VGA039. Throughout the study, participants will keep diaries to record details about any bleeding events, such as how often they occur, how long they last, and where they happen. The study will also monitor any side effects experienced during both the observation and treatment periods to ensure the safety of the participants.

Official TitleA 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
Principal SponsorVega Therapeutics, Inc
Study ContactClinical Trials- Vega Therapeutics
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Coagulation DisordersBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersCongenital, Hereditary, and Neonatal Diseases and Abnormalitiesvon Willebrand DiseasesCoagulation Protein DisordersBlood Coagulation Disorders, InheritedGenetic Diseases, Inborn

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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants who meet eligibility criteria and complete a 24-week observational phase will receive VGA039 SC for approximately 49 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

Arkansas Children's Hospital

Little Rock, United StatesOpen Arkansas Children's Hospital in Google Maps
Recruiting

Science 37, Inc. (Virtual Clinical MetaSite)

Morrisville, United States
Recruiting

Hemophilia Center of Western PA

Pittsburgh, United States
Recruiting

Washington Center for Bleeding Disorders

Seattle, United States
Recruiting
4 Study Centers