Actively Recruiting
A Multi-Modular Trial to Evaluate VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease and Other Bleeding Disorders (VIVID)
Led by Vega Therapeutics, Inc · Updated on 2025-08-26
116
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating VGA039 in a study called VIVID, which involves healthy volunteers and people with von Willebrand Disease (VWD) and other bleeding disorders. This study is designed in multiple parts to assess the safety, tolerability, and effects of intravenous (IV) and subcutaneous (SC) forms of VGA039. The study includes both single and multiple-dose evaluations and covers early phase 1 and phase 2 research. The study has five parts: Part 1 tests single ascending doses of IV or SC VGA039 or placebo in healthy volunteers with random assignment and masking. Part 2 involves open-label single ascending doses in people diagnosed with VWD. Part 3 studies multiple doses of SC VGA039 in VWD patients. Part 4 evaluates single doses given before minor surgery in VWD subjects. Part 5 is an open-label extension of multiple doses in eligible VWD patients who previously participated in VGA039 trials. Participants receive doses and are followed for 8 to 15 weeks depending on the administration route. Participants attend study visits for treatment, monitoring, and follow-up over several weeks. Researchers will assess safety by tracking treatment-emergent adverse events and measure drug levels in the blood and immune responses. Laboratory tests, vital signs, and ECGs are conducted to monitor health. The total duration of follow-up ranges from 8 weeks for SC dosing to 15 weeks for IV dosing. This study aims to provide important information on how VGA039 behaves in the body and its safety profile in both healthy and affected individuals.
CONDITIONS
Brief Title
Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 18 to 60 years for Parts 1 and 2
- Subjects aged 12 to 60 years for Parts 3 and 5
- No clinically significant laboratory, ECG, or vital signs abnormalities
- Body mass index of 18-32 kg/m2 for Part 1 subjects
- Subjects with symptomatic von Willebrand Disease for Part 2
- Hemoglobin level ≥ 8 g/dL and platelet count ≥ 150 × 10^9/L at screening for Part 2
You will not qualify if you...
- Use of hormonal contraceptives within 56 days prior to study drug administration
- Detection of blood clotting disorders such as FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at screening
- Other known pro-thrombotic disorders or abnormal previous laboratory thrombophilia results
- History of arterial or venous thrombosis, including superficial thrombophlebitis or embolism
- Evidence of renal, liver, nervous system, respiratory, cardiovascular, cerebrovascular, peripheral vascular, or metabolic diseases
- Baseline FVIII activity > 150 IU/dL for Part 1 subjects
- Baseline FVIII activity > 50 IU/dL for Parts 2, 3, 4, and 5 subjects
- Acute significant bleeding events requiring surgical or procedural intervention within 7 days before study drug administration for Parts 2, 3, 4, and 5 subjects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 weeks for IV single doses or 8 weeks for SC single doses; multiple dosing duration varies by cohort
Participants receive single or multiple doses of VGA039 or placebo depending on study part and cohort assignment.
1 to 8 dosing visits depending on cohort and part
Duration - Up to 15 weeks after IV dosing or 8 weeks after SC dosing
Participants are monitored for safety, tolerability, and pharmacodynamics after study drug administration.
Regular visits during follow-up period as per study schedule
Trial Site Locations
Total: 25 locations
1
Orthopedic Institute for Children (UCLA)
Los Angeles, California, United States, 90007
Actively Recruiting
2
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
3
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory
Atlanta, Georgia, United States, 30308
Actively Recruiting
5
Science 37, Inc.
Morrisville, North Carolina, United States, 27560
Actively Recruiting
6
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
7
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
8
University of Texas Southwestern
Dallas, Texas, United States, 75235
Actively Recruiting
9
Washington Center for Bleeding Disorders
Seattle, Washington, United States, 98101
Actively Recruiting
10
Versiti Comprehensive Center for Bleeding Disorders
Milwaukee, Wisconsin, United States, 53233
Actively Recruiting
11
Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre
Herston, Queenland, Australia, 4029
Actively Recruiting
12
Medical University of Vienna
Vienna, State of Vienna, Austria
Completed
13
Centro de Hemoterapia e Hematologia do Rio de Janeiro HEMORIO
Rio de Janeiro, Rio de Janeiro, Brazil, 20211-030
Actively Recruiting
14
Hemocentro Unicamp
Campinas, São Paulo, Brazil, 13083-878
Actively Recruiting
15
Hospital das Clinicas - USP Endereco
São Paulo, São Paulo, Brazil, 05403-010
Actively Recruiting
16
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
17
Queens University
Kingston, Ontario, Canada, K7L 3N6
Actively Recruiting
18
St. Michaels Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
19
K J Somaiya Super Speciality Hospital & Research Centre
Sion, Mumbai, India, 400022
Actively Recruiting
20
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, South Africa
Actively Recruiting
21
Queen Elizabeth Hospital Birmingham
Birmingham, Edgbaston, United Kingdom, B15 2TT
Actively Recruiting
22
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD.
Actively Recruiting
23
Royal Free Hospital
London, London, United Kingdom, NW3 2QG
Actively Recruiting
24
Royal London Hospital, Clinical Haematology Research
Whitechapel, London, United Kingdom, E12ES
Actively Recruiting
25
Imperial College Healthcare NHS Trust- Queen Charlotte's & Chelsea Hospital
London, United Kingdom
Actively Recruiting
Research Team
C
Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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