Study of VGA039 in Healthy Volunteers and Patients with Von Willebrand Disease (VIVID)

Launched by VEGA THERAPEUTICS, INC · Mar 8, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Study of VGA039, is looking at a new treatment for Von Willebrand Disease (VWD), which is a bleeding disorder. The researchers want to understand how safe the treatment is and how it works in both healthy volunteers and patients who have VWD. Participants will receive either an intravenous (IV) or a subcutaneous (SC) injection of the study drug, and the trial is taking place at multiple locations.

To be eligible for this study, participants should be between 18 and 60 years old and generally healthy, with no significant medical issues. For patients with Von Willebrand Disease, they must have a history of bleeding or bruising and meet specific blood test results. Participants can expect to be monitored closely throughout the study for their safety and response to the treatment. This trial is currently recruiting, and those interested should check if they meet the criteria before applying.

Gender

ALL

Eligibility criteria

• • Key Inclusion Criteria (All Subjects)
• • Subjects, 18 to 60 years of age, inclusive for Parts 1 and 2
• • Subjects, 12 to 60 years of age, inclusive for Parts 3 and 5
• • No clinically significant laboratory, ECG, or vital signs results.
• • Additional Key Inclusion Criteria (for Subjects in Part 1 Only) • Body mass index of 18-32 kg/m2
• • Additional Key Inclusion Criteria (for Subjects in Part 2 Only)
• • Subjects 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 Subjects)
• • Use of hormonal contraceptives within 56 days prior to administration of the study drug.
• • Subjects with detection of FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening.
• • Subjects 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 (Subjects in Part 1 Only)
• • • Baseline FVIII activity \> 150 IU/dL.
• • Additional Key Exclusion Criteria (Subjects 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.