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Clinical Trials in the USA / NCT05776069
Recruiting Phase 1/2

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

NCT05776069 · tracked via the Priya Life Science USA tracker
Sponsor
Vega Therapeutics, Inc
Phase
Phase 1/2
Started
2023-03-16
Last updated
2025-08-26

Condition(s) studied

Von Willebrand Diseases

Investigational drug(s) / intervention(s)

VGA039PlaceboVGA039

VGA039: Single doses of VGA039

Placebo: Single doses of Placebo

VGA039: Multiple doses of VGA039

Study 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

Sex
ALL
Min age
12 Years
Max age
60 Years
Healthy volunteers
Accepted
Key Inclusion Criteria (All Subjects) * Subjects, 18 to 60 years of age, inclusive for Parts 1 and 2 * Subjects, 12 to 60 years of age, inclusive for Parts 3 and 5 * No clinically significant laboratory, ECG, or vital signs results. Additional Key Inclusion Criteria (for Subjects in Part 1 Only) • Body mass index of 18-32 kg/m2 Additional Key Inclusion Criteria (for Subjects in Part 2 Only) * Subjects with VWD who are symptomatic, defined as having a history of bleeding or bruising. * Hemoglobin level ≥ 8 g/dL and platelet count ≥ 150 × 109/L at Screening. Exclusion Key Criteria (All Subjects) * Use of hormonal contraceptives within 56 days prior to administration of the study drug. * Subjects with detection of FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening. * Subjects with other known pro-thrombotic disorders or abnormal findings in any prior laboratory thrombophilia evaluation. * 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. Additional Key Exclusion Criterion (Subjects in Part 1 Only) • Baseline FVIII activity \> 150 IU/dL. Additional Key Exclusion Criteria (Subjects in Parts 2, 3, 4 and 5 Only) * Baseline FVIII activity \> 50 IU/dL. * Any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
Orthopedic Institute for Children (UCLA) Los Angeles California Recruiting
UC Davis Medical Center Sacramento California Recruiting
University of Colorado School of Medicine Aurora Colorado Recruiting
Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory Atlanta Georgia Recruiting
Science 37, Inc. Morrisville North Carolina Recruiting
Hemophilia Center of Western PA Pittsburgh Pennsylvania Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
University of Texas Southwestern Dallas Texas Recruiting
Washington Center for Bleeding Disorders Seattle Washington Recruiting
Versiti Comprehensive Center for Bleeding Disorders Milwaukee Wisconsin Recruiting
Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre Herston Queenland Recruiting
Medical University of Vienna Vienna State of Vienna Completed
Centro de Hemoterapia e Hematologia do Rio de Janeiro HEMORIO Rio de Janeiro Rio de Janeiro Recruiting
Hemocentro Unicamp Campinas São Paulo Recruiting
Hospital das Clinicas - USP Endereco São Paulo São Paulo Recruiting
Hamilton Health Sciences Corporation Hamilton Ontario Recruiting
Queens University Kingston Ontario Recruiting
St. Michaels Hospital Toronto Ontario Recruiting
K J Somaiya Super Speciality Hospital & Research Centre Sion Mumbai Recruiting
Charlotte Maxeke Johannesburg Academic Hospital Johannesburg South Africa Recruiting
Queen Elizabeth Hospital Birmingham Birmingham Edgbaston Recruiting
University Hospital Southampton NHS Foundation Trust Southampton Hampshire Recruiting
Royal Free Hospital London London Recruiting
Royal London Hospital, Clinical Haematology Research Whitechapel London Recruiting
Imperial College Healthcare NHS Trust- Queen Charlotte's & Chelsea Hospital London United Kingdom Recruiting

More Vega Therapeutics, Inc trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05776069 on ClinicalTrials.gov ↗ ← All trials in the USA