A Multi-Modular Trial to Evaluate VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease and Other Bleeding Disorders (VIVID)
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 60
Healthy Volunteers: t
View:
• Subjects, 18 to 60 years of age, inclusive for Parts 1 and 2
• 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.
Locations
United States
California
Orthopedic Institute for Children (UCLA)
RECRUITING
Los Angeles
UC Davis Medical Center
RECRUITING
Sacramento
Colorado
University of Colorado School of Medicine
RECRUITING
Aurora
Georgia
Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory
RECRUITING
Atlanta
North Carolina
Science 37, Inc.
RECRUITING
Morrisville
Pennsylvania
Hemophilia Center of Western PA
RECRUITING
Pittsburgh
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
University of Texas Southwestern
RECRUITING
Dallas
Washington
Washington Center for Bleeding Disorders
RECRUITING
Seattle
Wisconsin
Versiti Comprehensive Center for Bleeding Disorders
RECRUITING
Milwaukee
Other Locations
Australia
Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre
RECRUITING
Herston
Austria
Medical University of Vienna
COMPLETED
Vienna
Brazil
Hemocentro Unicamp
RECRUITING
Campinas
Centro de Hemoterapia e Hematologia do Rio de Janeiro HEMORIO
RECRUITING
Rio De Janeiro
Hospital das Clinicas - USP Endereco
RECRUITING
São Paulo
Canada
Hamilton Health Sciences Corporation
RECRUITING
Hamilton
Queens University
RECRUITING
Kingston
St. Michaels Hospital
RECRUITING
Toronto
India
K J Somaiya Super Speciality Hospital & Research Centre
RECRUITING
Sion
South Africa
Charlotte Maxeke Johannesburg Academic Hospital
RECRUITING
Johannesburg
United Kingdom
Queen Elizabeth Hospital Birmingham
RECRUITING
Birmingham
Imperial College Healthcare NHS Trust- Queen Charlotte's & Chelsea Hospital
RECRUITING
London
Royal Free Hospital
RECRUITING
London
University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
Royal London Hospital, Clinical Haematology Research
RECRUITING
Whitechapel
Contact Information
Primary
Clinical Trials
medinfo@star-therapeutics.com
650-466-8041
Time Frame
Start Date: 2023-03-16
Estimated Completion Date: 2029-12
Participants
Target number of participants: 116
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Vega Therapeutics, Inc