BridgeMD
New treatment option for Von Willebrand Diseases
Official title Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)
ClinicalTrials.gov ID: NCT05776069
What this study is testing
What is VGA039?
VGA039 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for von willebrand diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Key (All people)
- people, 18 to 60 years of age, inclusive for Parts 1 and 2
- people, 12 to 60 years of age, inclusive for Parts 3 and 5
- No clinically significant laboratory, ECG, or vital signs results. Additional Key (for people in Part 1 Only) Body mass index of 18-32 kg/m2...
- people with VWD who are symptomatic, defined as having a history of bleeding or bruising.
You likely can't join if
- (people 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.
See the full eligibility criteria
- Key (All people)
- people, 18 to 60 years of age, inclusive for Parts 1 and 2
- people, 12 to 60 years of age, inclusive for Parts 3 and 5
- No clinically significant laboratory, ECG, or vital signs results. Additional Key (for people in Part 1 Only) Body mass index of 18-32 kg/m2 Additional Key (for people in Part 2 Only)
- people 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 people)
- Use of hormonal contraceptives within 56 days prior to administration of the study drug.
- people with detection of FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening.
- people 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 (people in Part...
- Baseline FVIII activity \> 150 IU/dL. Additional Key
- (people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Sacramento, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Morrisville, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Herston, Queenland, Australia
- Vienna, State of Vienna, Austria
- Rio de Janeiro, Rio de Janeiro, Brazil
- Campinas, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- Toronto, Ontario, Canada
- Sion, Mumbai, India
- Johannesburg, South Africa
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Sacramento, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; Morrisville, North Carolina, United States; Pittsburgh, Pennsylvania, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.