About this trial
This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- VGA039