Von Willebrand DiseasesPhase 1/2NCT05776069
Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)
A Phase 1/2 study testing VGA039 in people with Von Willebrand Diseases, run by Vega Therapeutics, Inc at 25 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Von Willebrand Diseases
- What is being tested?
- VGA039
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 25 sitesin 8 countries
- Study dates
- 16 Mar 2023to Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
25 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 8 countries
United States10 sites, 10 recruiting
- Recruiting
Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory
Atlanta, Georgia, 30308
- Recruiting
University of Colorado School of Medicine
Aurora, Colorado, 80045
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75235
- Recruiting
Orthopedic Institute for Children (UCLA)
Los Angeles, California, 90007
- Recruiting
Versiti Comprehensive Center for Bleeding Disorders
Milwaukee, Wisconsin, 53233
- Recruiting
Science 37, Inc.
Morrisville, North Carolina, 27560
Science 37 Recruitment Team, 984-377-3737, recruitment@science37.com
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Recruiting
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, 15213
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
- Recruiting
Washington Center for Bleeding Disorders
Seattle, Washington, 98101
United Kingdom5 sites, 5 recruiting
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, Edgbaston, B15 2TT
- Recruiting
Royal Free Hospital
London, London, NW3 2QG
- Recruiting
Imperial College Healthcare NHS Trust- Queen Charlotte's & Chelsea Hospital
London
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD.
- Recruiting
Royal London Hospital, Clinical Haematology Research
Whitechapel, London, E12ES
Brazil3 sites, 3 recruiting
- Recruiting
Hemocentro Unicamp
Campinas, São Paulo, 13083-878
- Recruiting
Centro de Hemoterapia e Hematologia do Rio de Janeiro HEMORIO
Rio de Janeiro, Rio de Janeiro, 20211-030
- Recruiting
Hospital das Clinicas - USP Endereco
São Paulo, São Paulo, 05403-010
Canada3 sites, 3 recruiting
- Recruiting
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8N 3Z5
- Recruiting
Queens University
Kingston, Ontario, K7L 3N6
- Recruiting
St. Michaels Hospital
Toronto, Ontario, M5B 1W8
Australia1 site, 1 recruiting
- Recruiting
Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre
Herston, Queenland, 4029
India1 site, 1 recruiting
- Recruiting
K J Somaiya Super Speciality Hospital & Research Centre
Sion, Mumbai, 400022
South Africa1 site, 1 recruiting
- Recruiting
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg
About this study
Official title: A Multi-Modular Trial to Evaluate VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease and Other Bleeding Disorders (VIVID)
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.
Read the detailed description
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.
- Conditions
- Von Willebrand Diseases
- Being tested
- VGA039, Placebo
- Keywords
- Von Willebrand Disorder, VWD, Star Therapeutics, Vega Therapeutics, VIVID, VIVID-1, VIVID-2, VIVID-3, VIVID-5, Bleeding disorders, VGA039, Blood coagulation disorders
- Medical subject headings
- von Willebrand Diseases, Hemostatic Disorders, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VGA039Drug
Single doses of VGA039
PlaceboOther
Single doses of Placebo
VGA039Drug
Multiple doses of VGA039
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Placebo comparator | Cohorts 1-8 IV or SC VGA039 or Placebo dose to be determined Receives: Drug: VGA039; Other: Placebo |
| Part 2 | Experimental | Cohorts A-H IV or SC VGA039 dose to be determined Receives: Drug: VGA039 |
| Part 3 | Experimental | Cohorts MD-1 to MD-4, SC VGA039 multiple doses, dose to be determined Receives: Drug: VGA039 |
| Part 4 | Experimental | Cohorts of VGA039 single dose for surgical prophylaxis Receives: Drug: VGA039 |
| Part 5 | Experimental | Multiple doses of VGA039 in open label extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), including dose-limiting toxicities (DLTs).
Measured: From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively
Secondary outcomes (3)
Plasma Concentrations of single IV and SC doses of VGA039
Measured: From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
Pharmacodynamics of single IV and SC doses of VGA039
Measured: From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
Incidence of Anti-drug antibodies to VGA039
Measured: From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start16 Mar 2023
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vega Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776069
- Sponsor's protocol ID
- VGA039-CP001
- Status last verified
- Aug 2025
- First submitted
- 8 Mar 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Modular Trial to Evaluate VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease and Other Bleeding Disorders (VIVID)
- ClinicalTrials.gov ID
- NCT05776069
- Acronym / sponsor ID
- VGA039-CP001
- Conditions
- Von Willebrand Diseases
- Keywords
- Von Willebrand Disorder, VWD, Star Therapeutics, Vega Therapeutics, VIVID, VIVID-1, VIVID-2, VIVID-3
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Vega Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Placebo comparator | Drug: VGA039, Other: PlaceboCohorts 1-8 IV or SC VGA039 or Placebo dose to be determined |
| Part 2 | Experimental | Drug: VGA039Cohorts A-H IV or SC VGA039 dose to be determined |
| Part 3 | Experimental | Drug: VGA039Cohorts MD-1 to MD-4, SC VGA039 multiple doses, dose to be determined |
| Part 4 | Experimental | Drug: VGA039Cohorts of VGA039 single dose for surgical prophylaxis |
| Part 5 | Experimental | –Multiple doses of VGA039 in open label extension |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VGA039Single doses of VGA039 | Drug | Part 1, Part 2, Part 4 |
| PlaceboSingle doses of Placebo | Other | Part 1 |
| VGA039Multiple doses of VGA039 | Drug | Part 3 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Time frame: From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively
Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), including dose-limiting toxicities (DLTs).
3 secondary outcomes
Plasma Concentrations of single IV and SC doses of VGA039
Time frame: From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
Pharmacodynamics of single IV and SC doses of VGA039
Time frame: From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
Incidence of Anti-drug antibodies to VGA039
Time frame: From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Von Willebrand Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingObservational study
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Heavy Menstrual Bleeding, Bleeding Disorder
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
RecruitingObservational study
Blood Clotting Markers and Heart Ultrasound in People With Device-Detected Atrial Fibrillation
Device-detected Atrial Fibrillation, Subclinical Atrial Fibrillation
RecruitingPhase 3
A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients With VWD
Von Willebrand Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
25 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VGA039 in people with Von Willebrand Diseases, run by Vega Therapeutics, Inc at 25 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, United Kingdom, Brazil, Canada, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials (650-466-8041, medinfo@star-therapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability] (time frame: From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.