NCT05776069 Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)
| NCT ID | NCT05776069 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Vega Therapeutics, Inc |
| Condition | Von Willebrand Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2023-03-16 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 116 participants in total. It began in 2023-03-16 with a primary completion date of 2029-12.
⚠ 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
The VIVID study is structured in a master protocol format comprised of multiple parts that evaluate intravenous (IV) and subcutaneous (SC) VGA039 in healthy volunteers and subjects with von Willebrand Disease (VWD) and other bleeding disorders.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05776069 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 60 Years, studying Von Willebrand Diseases. 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 NCT05776069 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05776069 currently recruiting?
Yes, NCT05776069 is actively recruiting participants. Contact the research team at medinfo@star-therapeutics.com for enrollment information.
Where is the NCT05776069 trial being conducted?
This trial is being conducted at Los Angeles, United States, Sacramento, United States, Aurora, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT05776069 clinical trial?
NCT05776069 is sponsored by Vega Therapeutics, Inc. The trial plans to enroll 116 participants.