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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Vega Therapeutics, Inc
Study ID
NCT05776069
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Von Willebrand Diseases

Eligibility Criteria

Sex
ALL
Age
12 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • VGA039 — DRUG
    Single doses of VGA039
  • Placebo — OTHER
    Single doses of Placebo
  • VGA039 — DRUG
    Multiple doses of VGA039

Study Details

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.

Key Dates

Start date
Mar 16, 2023
Status verified
Aug 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Part 1
    Cohorts 1-8 IV or SC VGA039 or Placebo dose to be determined
  • Experimental: Part 2
    Cohorts A-H IV or SC VGA039 dose to be determined
  • Experimental: Part 3
    Cohorts MD-1 to MD-4, SC VGA039 multiple doses, dose to be determined
  • Experimental: Part 4
    Cohorts of VGA039 single dose for surgical prophylaxis
  • Experimental: Part 5
    Multiple doses of VGA039 in open label extension

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 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Orthopedic Institute for Children (UCLA)Los AngelesCalifornia90007-
UC Davis Medical CenterSacramentoCalifornia95817-
University of Colorado School of MedicineAuroraColorado80045-
Hemophilia of Georgia Center for Bleeding & Clotting Disorders of EmoryAtlantaGeorgia30308-
Science 37, Inc.MorrisvilleNorth Carolina27560
Science 37 Recruitment Team
[email protected]
984-377-3737
Hemophilia Center of Western PAPittsburghPennsylvania15213-
Vanderbilt University Medical CenterNashvilleTennessee37232-
University of Texas SouthwesternDallasTexas75235-
Washington Center for Bleeding DisordersSeattleWashington98101-
Versiti Comprehensive Center for Bleeding DisordersMilwaukeeWisconsin53233-

Find similar trials in Los Angeles, CA

By research site
Orthopedic Institute for Children (UCLA)· Los Angeles, CAUC Davis Medical Center· Sacramento, CAUniversity of Colorado School of Medicine· Aurora, COHemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory· Atlanta, GAScience 37, Inc.· Morrisville, NCHemophilia Center of Western PA· Pittsburgh, PA

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