Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)
Start Date
10/15/2025
Completion Date
10/1/2028
Summary
This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)
Detailed Description
This Phase 3 multicenter, open-label, single-sequence cross-over study will investigate the safety and efficacy of subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD. The study consists of an Observational Period of at least 24 weeks followed by an Active Treatment Period of approximately 49 weeks of VGA039 treatment. Bleeding data and details of treatments used will be collected from each patient during both study periods. The number, duration, location, and types of bleeds experienced, as well as treatments for bleeds, will be recorded in patient diaries. Adverse events will also be monitored and recorded throughout both study periods.
Eligibility Criteria
Age Range: 12 years to 75 years
Interventions
VGA039
Conditions
Locations
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United States
Luskin Orthopaedic Institute For Children
Los Angeles, California 90007
United States
Stanford University
Palo Alto, California 94304
United States
UC Davis Medical Center
Sacramento, California 95817
United States
University of California San Francisco
San Francisco, California 94143
United States
Yale University School of Medicine
New Haven, Connecticut 06510
United States
Emory University Hospital
Atlanta, Georgia 30308
United States
Children's Healthcare of Atlanta
Atlanta, Georgia 30329
United States
University of Michigan Health
Ann Arbor, Michigan 48109
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Science 37, Inc. (Virtual Clinical MetaSite)
Morrisville, North Carolina 27560
United States
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania 15213
United States
UT Southwestern Children's Hospital
Dallas, Texas 75235
United States
Washington Center for Bleeding Disorders
Seattle, Washington 98101
United States
Royal Prince Alfred Hospital, Institute of Haematology
Sydney, New South Wales (nsw) 2050
Australia
Royal Brisbane & Women's Hospital (RBWH), Queensland Haemophilia Centre
Brisbane, Queensland 4029
Australia
The Alfred Hospital (Alfred Health),Monash University
Melbourne, Victoria 3004
Australia
Medical University of Vienna
Vienna, 1090
Austria
Multihemo - Oncoclínicas
Recife, Pernambuco
Brazil
Centro de Hemoterapia e Hematologia do Rio de Janeiro (HEMORIO)
Rio de Janeiro, Rio de Janeiro 20211-030
Brazil
emocentro UNICAMP (Centro de Hematologia e Hemoterapia da UNICAMP), University of Campinas (UNICAMP)
Campinas, São Paulo 13083-878
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP)
São Paulo, São Paulo 05403
Brazil
K Eristavi National Center of Experimental and Clinical Surgery (ქირურგიის ეროვნული ცენტრი)
Tbilisi, 0159
Georgia
Vivantes Klinikum im Friedrichshain
Berlin, 10249
Germany
Frankfurt University Hospital (Universitätsmedizin Frankfurt)
Frankfurt, 60596
Germany
St. James's Hospital, National Coagulation Centre
Dublin, Dublin D08 NHY1
Ireland
University of Milan
Milan, Milan 20122
Italy
Azienda Ospedaliero-Universitaria Careggi (Careggi University Hospital)
Florence, 50134
Italy
Worthwhile Clinical Trials Lakeview Hospital
Benoni, Gauteng 1501
South Africa
Charlotte Maxeke Johannesburg Academic Hospital School of Pathology Clinical Haematologist
Johannesburg, 2194
South Africa
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London, Greater London W12 0HS
United Kingdom
Royal Free London NHS Foundation Trust,
London, London NW3 2QG
United Kingdom