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

August 19, 2025 updated by: Vega Therapeutics, Inc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Queenland
      • Herston, Queenland, Australia, 4029
        • Recruiting
        • Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre
  • Austria
    • Vienna
      • Vienna, Vienna, Austria
        • Completed
        • Medical University of Vienna
  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20211-030
        • Recruiting
        • Centro de Hemoterapia e Hematologia do Rio de Janeiro HEMORIO
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-878
        • Recruiting
        • Hemocentro UNICAMP
      • São Paulo, São Paulo, Brazil, 05403-010
        • Recruiting
        • Hospital das Clinicas - USP Endereco
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Recruiting
        • Hamilton Health Sciences Corporation
      • Kingston, Ontario, Canada, K7L 3N6
        • Recruiting
        • Queens University
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michaels Hospital
  • India
    • Mumbai
      • Sion, Mumbai, India, 400022
        • Recruiting
        • K J Somaiya Super Speciality Hospital & Research Centre
  • South Africa
      • Johannesburg, South Africa
        • Recruiting
        • Charlotte Maxeke Johannesburg Academic Hospital
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Imperial College Healthcare NHS Trust- Queen Charlotte's & Chelsea Hospital
    • Edgbaston
      • Birmingham, Edgbaston, United Kingdom, B15 2TT
        • Recruiting
        • Queen Elizabeth Hospital Birmingham
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD.
        • Recruiting
        • University Hospital Southampton NHS Foundation Trust
    • London
      • London, London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
      • Whitechapel, London, United Kingdom, E12ES
        • Recruiting
        • Royal London Hospital, Clinical Haematology Research
  • United States
    • California
      • Los Angeles, California, United States, 90007
        • Recruiting
        • Orthopedic Institute for Children (UCLA)
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory
    • North Carolina
      • Morrisville, North Carolina, United States, 27560
        • Recruiting
        • Science 37, Inc.
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Hemophilia Center of Western PA
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • University of Texas Southwestern
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Washington Center for Bleeding Disorders
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Versiti Comprehensive Center for Bleeding Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Part 1
Cohorts 1-8 IV or SC VGA039 or Placebo dose to be determined
Drug: VGA039
Single doses of VGA039
Other: Placebo
Single doses of Placebo
Drug: VGA039
Multiple doses of VGA039
Experimental: Part 2
Cohorts A-H IV or SC VGA039 dose to be determined
Drug: VGA039
Single doses of VGA039
Drug: VGA039
Multiple doses of VGA039
Experimental: Part 3
Cohorts MD-1 to MD-4, SC VGA039 multiple doses, dose to be determined
Drug: VGA039
Single doses of VGA039
Drug: VGA039
Multiple doses of VGA039
Experimental: Part 4
Cohorts of VGA039 single dose for surgical prophylaxis
Drug: VGA039
Single doses of VGA039
Drug: VGA039
Multiple doses of VGA039
Experimental: Part 5
Multiple doses of VGA039 in open label extension

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vega Therapeutics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VGA039-CP001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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