Evaluating VGA039 in Healthy Volunteers and Patients with Von Willebrand Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The VIVID study is a multi-part clinical trial assessing the safety and efficacy of VGA039, administered both intravenously and subcutaneously, in healthy volunteers and patients with von Willebrand Disease (VWD). It includes a randomized, double-blind, placebo-controlled phase for healthy participants, followed by open-label phases for VWD patients. Participants will be monitored for 15 weeks for intravenous dosing and 8 weeks for subcutaneous dosing. The study aims to explore both single and multiple doses, as well as surgical prophylaxis applications of VGA039.

Why it matters

Who can join: the full rules

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.

Where it's running

• Orthopedic Institute for Children (UCLA)
  Los Angeles, California, United States Recruiting
• UC Davis Medical Center
  Sacramento, California, United States Recruiting
• University of Colorado School of Medicine
  Aurora, Colorado, United States Recruiting
• Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory
  Atlanta, Georgia, United States Recruiting
• Science 37, Inc.
  Morrisville, North Carolina, United States Recruiting
• Hemophilia Center of Western PA
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials
• Email: medinfo@star-therapeutics.com
• Phone: 650-466-8041

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.