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New treatment option for Von Willebrand Disease (VWD)
Official title Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)
ClinicalTrials.gov ID: NCT07115004
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 disease (vwd).
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
- This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)
- Phase 3: a large, late-stage study
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 75
You may be able to join if
- Key 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
You likely can't join if
- Use of routine prophylaxis of VWF-containing concentrates defined as at least 1 VWF-containing concentrate infusion to prevent or reduce bleeding per...
- 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...
- Baseline FVIII activity \> lower limit of normal (LLN)
See the full eligibility criteria
- Key 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Atlanta, Georgia, United States
- Minneapolis, Minnesota, United States
- Morrisville, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
- Tbilisi, Georgia
- Frankfurt, Germany
- Johannesburg, South Africa
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Los Angeles, California, United States; Sacramento, California, United States; San Francisco, California, United States; Atlanta, Georgia, United States; Minneapolis, Minnesota, United States and 7 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.