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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: VGA039 (drug), Placebo (other), VGA039 (drug)
How long the study runs: Study runs about 81 months (dates as stated)
About the drug or intervention: VGA039 — drug: Single doses of VGA039 · Placebo — other: Single doses of Placebo · VGA039 — drug: Multiple doses of VGA039
Patient visit burden: Not specified by the sponsor

In plain English

This study, called VIVID, is testing a medicine called VGA039 in healthy volunteers and in people with Von Willebrand Disease, a condition that affects blood clotting. It is run by Vega Therapeutics, Inc. The aim of the different study parts is not fully described in the registry data.

Who can take part

Aged 18 to 60 for Parts 1 and 2, or 12 to 60 for Parts 3 and 5
No clinically significant results on laboratory tests, heart tracing (electrocardiogram, or ECG), or vital signs
For Part 1 only: body mass index between 18 and 32
For Part 2 only: symptomatic Von Willebrand Disease, meaning a history of bleeding or bruising, plus haemoglobin level of 8 g/dL or more and platelet count of at least 150 × 10⁹/L at screening

Who may not be able to

Use of hormonal contraceptives within 56 days before receiving the study medicine
Certain blood-clotting risk factors found at screening, such as Factor V Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome
Other known conditions that raise the risk of blood clots, or abnormal results from earlier blood-clotting tests
Past history of blood clots in arteries or veins, including superficial thrombophlebitis, or embolism
Evidence of kidney, liver, nervous system, breathing, heart, brain blood vessel, limb blood vessel, or metabolic problems
For Part 1 only: baseline factor VIII activity above 150 IU/dL
For Parts 2, 3, 4 and 5 only: baseline factor VIII activity above 50 IU/dL, or a serious bleeding event needing surgery or a procedure within 7 days before receiving the study medicine

What taking part involves

• Not stated — ask the trial team

Time commitment: Number of visits, study duration, and what taking part involves: not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 12 Years to 60 Years
Who: All
Number of participants: 116
Started: 2023-03-16
Last checked: 2025-08

Plain English Summary

What is this study?

• Testing a new treatment for von willebrand diseases
• Phase1/Phase2 - 116 participants
• 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

Who can take part?

• Ages 12 Years to 60 Years
• Diagnosed with von willebrand diseases

Where?

• Birmingham - Queen Elizabeth Hospital Birmingham
• Southampton - University Hospital Southampton NHS Foundation Trust
• London - Royal Free Hospital
• Whitechapel - Royal London Hospital, Clinical Haematology Research
• +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This first-in-human study consists of 5 parts based on the subject population. Part 1 is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) evaluation of IV or SC VGA039 or placebo in up to 8 cohorts in healthy volunteers. Part 2 is an open-label, SAD of SC or IV VGA039 in up to 8 cohorts in subjects diagnosed with VWD. All participants will be enrolled, treated, and followed up for 15 weeks (IV SAD) or 8 weeks(SC SAD). Part 3 is an open-label, Phase 1b study of SC multiple doses (MD) of VGA039 in up to 4 cohorts. Part 4 is an open-label, Phase 2 study of SC single, surgical prophylaxis (SP) doses of VGA039 administered prior to a minor surgical procedure in subjects diagnosed with VWD in up to 2 cohorts. Part 5 is an open-label extension (OLE) study of SC MD of VGA039 in eligible subjects diagnosed with VWD who have previously participated in a VGA039 interventional trial.

Von Willebrand Diseases

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 12 Years - 60 Years
Who can join: All genders

What the study is looking for

✓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

See the full 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.