NCT07115004 Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)
| NCT ID | NCT07115004 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vega Therapeutics, Inc |
| Condition | Von Willebrand Disease (VWD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2025-10-15 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)
Eligibility Criteria
Key Inclusion Criteria * 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 Exclusion Criteria * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07115004 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 75 Years, studying Von Willebrand Disease (VWD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07115004 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT07115004 currently recruiting?
Yes, NCT07115004 is actively recruiting participants. Contact the research team at medinfo@star-therapeutics.com for enrollment information.
Where is the NCT07115004 trial being conducted?
This trial is being conducted at Little Rock, United States, Los Angeles, United States, Sacramento, United States, San Francisco, United States and 10 additional locations.
Who is sponsoring the NCT07115004 clinical trial?
NCT07115004 is sponsored by Vega Therapeutics, Inc. The trial plans to enroll 60 participants.