Clinical Trials in Italy / NCT07115004
Recruiting
Phase 3
Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)
NCT07115004 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Von Willebrand Disease (VWD)
Investigational drug(s) / intervention(s)
VGA039: VGA039 SC administered for 49-weeks during the interventional phase following a 24-week observational period.
Study summary
This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)
Eligibility
Key Inclusion Criteria
* 12 to 75 years of age, inclusive
* No clinically significant laboratory, ECG, or vital signs results
* Documented diagnosis consistent with VWD of any type
* Historical annualized bleeding rate (ABR; excluding menstrual bleeds and bleeds under the skin) of both untreated and treated bleeds ≥12 per year
* Patients with VWD who are judged by the investigator to be suitable candidates for routine prophylaxis to reduce the frequency of bleeding episodes
* Hemoglobin level ≥ 8 g/dL and platelet count ≥ 100 x 109/L at Screening
Key Exclusion Criteria
* Use of routine prophylaxis of VWF-containing concentrates defined as at least 1 VWF-containing concentrate infusion to prevent or reduce bleeding per week during the previous 6 months prior to screening
* Planning to initiate routine prophylaxis with VWF-containing concentrates or any other hemostatic treatment during the study
* Patients with pro-thrombotic disorders or abnormal findings on laboratory thrombophilia evaluation performed at screening or previously documented
* 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
* Baseline FVIII activity \> lower limit of normal (LLN)
Primary outcome measure(s)
- Incidence of bleeding events [Efficacy] — Time Frame: From 7 days after informed consent until 49 weeks after SC study drug initiation
Trial sites (32)
| Facility | City | Region | Status |
|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | Recruiting |
| Luskin Orthopaedic Institute For Children | Los Angeles | California | Recruiting |
| Stanford University | Palo Alto | California | Recruiting |
| UC Davis Medical Center | Sacramento | California | Recruiting |
| University of California San Francisco | San Francisco | California | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | Recruiting |
| Emory University Hospital | Atlanta | Georgia | Recruiting |
| Children's Healthcare of Atlanta | Atlanta | Georgia | Recruiting |
| University of Michigan Health | Ann Arbor | Michigan | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | Recruiting |
| Science 37, Inc. (Virtual Clinical MetaSite) | Morrisville | North Carolina | Recruiting |
| Hemophilia Center of Western PA | Pittsburgh | Pennsylvania | Recruiting |
| UT Southwestern Children's Hospital | Dallas | Texas | Recruiting |
| Washington Center for Bleeding Disorders | Seattle | Washington | Recruiting |
| Royal Prince Alfred Hospital, Institute of Haematology | Sydney | New South Wales (nsw) | Recruiting |
| Royal Brisbane & Women's Hospital (RBWH), Queensland Haemophilia Centre | Brisbane | Queensland | Recruiting |
| The Alfred Hospital (Alfred Health),Monash University | Melbourne | Victoria | Recruiting |
| Medical University of Vienna | Vienna | Austria | Recruiting |
| Multihemo - Oncoclínicas | Recife | Pernambuco | Recruiting |
| Centro de Hemoterapia e Hematologia do Rio de Janeiro (HEMORIO) | Rio de Janeiro | Rio de Janeiro | Recruiting |
| emocentro UNICAMP (Centro de Hematologia e Hemoterapia da UNICAMP), University of Campinas (UNICAMP) | Campinas | São Paulo | Recruiting |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP) | São Paulo | São Paulo | Recruiting |
| K Eristavi National Center of Experimental and Clinical Surgery (ქირურგიის ეროვნული ცენტრი) | Tbilisi | Georgia | Recruiting |
| Vivantes Klinikum im Friedrichshain | Berlin | Germany | Recruiting |
| Frankfurt University Hospital (Universitätsmedizin Frankfurt) | Frankfurt | Germany | Recruiting |
| St. James's Hospital, National Coagulation Centre | Dublin | Dublin | Recruiting |
| University of Milan | Milan | Milan | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi (Careggi University Hospital) | Florence | Italy | Recruiting |
| Worthwhile Clinical Trials Lakeview Hospital | Benoni | Gauteng | Recruiting |
| Charlotte Maxeke Johannesburg Academic Hospital School of Pathology Clinical Haematologist | Johannesburg | South Africa | Recruiting |
| Imperial College Healthcare NHS Trust, Hammersmith Hospital | London | Greater London | Recruiting |
| Royal Free London NHS Foundation Trust, | London | London | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07115004 on ClinicalTrials.gov ↗ ← All trials in Italy