Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)
Start Date
3/16/2023
Completion Date
12/1/2029
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.
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.
Eligibility Criteria
Age Range: 12 years to 60 years
Interventions
VGA039
Placebo
VGA039
Conditions
Locations
Orthopedic Institute for Children (UCLA)
Los Angeles, California 90007
United States
UC Davis Medical Center
Sacramento, California 95817
United States
University of Colorado School of Medicine
Aurora, Colorado 80045
United States
Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory
Atlanta, Georgia 30308
United States
Science 37, Inc.
Morrisville, North Carolina 27560
United States
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania 15213
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
University of Texas Southwestern
Dallas, Texas 75235
United States
Washington Center for Bleeding Disorders
Seattle, Washington 98101
United States
Versiti Comprehensive Center for Bleeding Disorders
Milwaukee, Wisconsin 53233
United States
Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre
Herston, Queenland 4029
Australia
Medical University of Vienna
Vienna, State of Vienna
Austria
Centro de Hemoterapia e Hematologia do Rio de Janeiro HEMORIO
Rio de Janeiro, Rio de Janeiro 20211-030
Brazil
Hemocentro Unicamp
Campinas, São Paulo 13083-878
Brazil
Hospital das Clinicas - USP Endereco
São Paulo, São Paulo 05403-010
Brazil
Hamilton Health Sciences Corporation
Hamilton, Ontario L8N 3Z5
Canada
Queens University
Kingston, Ontario K7L 3N6
Canada
St. Michaels Hospital
Toronto, Ontario M5B 1W8
Canada
K J Somaiya Super Speciality Hospital & Research Centre
Sion, Mumbai 400022
India
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg,
South Africa
Queen Elizabeth Hospital Birmingham
Birmingham, Edgbaston B15 2TT
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire SO16 6YD.
United Kingdom
Royal Free Hospital
London, London NW3 2QG
United Kingdom
Royal London Hospital, Clinical Haematology Research
Whitechapel, London E12ES
United Kingdom
Imperial College Healthcare NHS Trust- Queen Charlotte's & Chelsea Hospital
London,
United Kingdom