Testing VGA039 against a placebo for von willebrand diseases
Official title: Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)
A Multi-Modular Trial to Evaluate VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease and Other Bleeding Disorders (VIVID)
Interventions
VGA039
Single doses of VGA039
Placebo
Single doses of Placebo
VGA039
Multiple doses of VGA039
Canadian Sites (3)
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Queens University
Kingston, Ontario, Canada
St. Michaels Hospital
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- +Additional Key Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → (for Subjects in Part 1 Only) • Body mass index of 18-32 kg/m2
- +(All Subjects)
- +No clinically significant laboratory, ECG, or vital signs results.
- +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 ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +ExclusionExclusion criteriaThe things that would prevent someone from taking part.Read more → Key Criteria (All Subjects)
- +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)
- +BaselineBaselineYour starting measurements, taken before treatment begins.Read more → 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.
- +Use of hormonal contraceptives within 56 days prior to administration of the study drug.
Exclusion
- −(Subjects in Parts 2, 3, 4 and 5 Only)
- −BaselineBaselineYour starting measurements, taken before treatment begins.Read more → FVIII activity \> 50 IU/dL.
- −Any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
What is being given or done in this study: VGA039, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 5 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 12 years to 60 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 116 people.
The study is currently expected to finish around December 2029.
The main measurement is taken over: From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence of Treatment-Emergent Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → [Safety and tolerability] — measured over From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05776069 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About VGA039Drug
Single doses of VGA039
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboOther
Single doses of Placebo
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About VGA039Drug
Multiple doses of VGA039
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 12 years to 60 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 12 years to 60 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively.
The study as a whole is currently expected to finish around 2029-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 116 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Hamilton, Ontario, Canada; Kingston, Ontario, Canada; Toronto, Ontario, Canada; Seattle, Washington, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (1)
Washington Center for Bleeding Disorders
Seattle, Washington, United States
Think this trial might be right for you?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.