Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-75
SponsorVega Therapeutics, Inc

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

Treatment groups

60 Participants
are divided into 1 treatment group

Locations

14
Georgia
K Eristavi National Center of Experimental and Clinical Surgery (ქირურგიის ეროვნული ცენტრი)0159, Tbilisi Georgia
Germany
Frankfurt University Hospital (Universitätsmedizin Frankfurt)60596, Frankfurt Germany
South Africa
Charlotte Maxeke Johannesburg Academic Hospital School of Pathology Clinical Haematologist2194, Johannesburg South Africa
United States
Arkansas
Arkansas Children's Hospital72202, Little Rock United States

Sponsors and collaborators

Vega Therapeutics, Inc

Lead sponsor