RecruitingPhase 1Phase 2NCT05776069

Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)

A Multi-Modular Trial to Evaluate VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease and Other Bleeding Disorders (VIVID)

Sponsor

Vega Therapeutics, Inc

Enrollment

116 participants

Start Date

Mar 16, 2023

Study Type

INTERVENTIONAL

Conditions

Von Willebrand Diseases

Summary

The VIVID study is structured in a master protocol format comprised of multiple parts that evaluate intravenous (IV) and subcutaneous (SC) VGA039 in healthy volunteers and subjects with von Willebrand Disease (VWD) and other bleeding disorders.

Eligibility

Min Age: 12 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests VGA039, an investigational drug designed to treat Von Willebrand Disease (VWD) — a common inherited bleeding disorder where a key protein (Von Willebrand Factor, or VWF) that helps blood clot is either absent, reduced, or dysfunctional. People with VWD can experience heavy menstrual bleeding, prolonged bleeding from cuts, and surgical complications. VGA039 is designed to increase the level or function of VWF or Factor VIII (which VWF carries) to control bleeding. The trial includes healthy volunteers aged 18–60 (in early parts) and patients with VWD who are symptomatic (history of bleeding or bruising), aged 12–60. Participants must have no significant cardiovascular, liver, kidney, or clotting disorder history, must not have used hormonal contraceptives in the prior 56 days, and must not have known pro-thrombotic (clot-causing) risk factors like Factor V Leiden mutation. Participants receive VGA039 via injection and are closely monitored with blood tests and safety assessments. For VWD patients — particularly those with heavier symptoms for whom current treatments (like desmopressin or clotting factor concentrates) are insufficient — a new, effective therapy could significantly reduce the bleeding burden and improve quality of life.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVGA039

Single doses of VGA039

OTHERPlacebo

Single doses of Placebo

DRUGVGA039

Multiple doses of VGA039

Locations(25)

Orthopedic Institute for Children (UCLA)

Los Angeles, California, United States

UC Davis Medical Center

Sacramento, California, United States

University of Colorado School of Medicine

Aurora, Colorado, United States

Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory

Atlanta, Georgia, United States

Science 37, Inc.

Morrisville, North Carolina, United States

Hemophilia Center of Western PA

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

Washington Center for Bleeding Disorders

Seattle, Washington, United States

Versiti Comprehensive Center for Bleeding Disorders

Milwaukee, Wisconsin, United States

Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre

Herston, Queenland, Australia

Medical University of Vienna

Vienna, State of Vienna, Austria

Centro de Hemoterapia e Hematologia do Rio de Janeiro HEMORIO

Rio de Janeiro, Rio de Janeiro, Brazil

Hemocentro Unicamp

Campinas, São Paulo, Brazil

Hospital das Clinicas - USP Endereco

São Paulo, São Paulo, Brazil

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Queens University

Kingston, Ontario, Canada

St. Michaels Hospital

Toronto, Ontario, Canada

K J Somaiya Super Speciality Hospital & Research Centre

Sion, Mumbai, India

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, South Africa

Queen Elizabeth Hospital Birmingham

Birmingham, Edgbaston, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

Royal Free Hospital

London, London, United Kingdom

Royal London Hospital, Clinical Haematology Research

Whitechapel, London, United Kingdom

Imperial College Healthcare NHS Trust- Queen Charlotte's & Chelsea Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05776069

Related Trials

ATHNdataset Registry

NCT068205151 location

Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions

NCT037731592 locations

ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders

NCT0439862871 locations

Von Willebrand Factor in Pregnancy (VIP) Study

NCT0414637611 locations

Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

NCT059164699 locations