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Clinical Trials in the UK / NCT07115004
Recruiting Phase 3

Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)

NCT07115004 · tracked via the Priya Life Science UK tracker
Sponsor
Vega Therapeutics, Inc
Phase
Phase 3
Started
2025-10-15
Last updated
2026-09-14

Condition(s) studied

Von Willebrand Disease (VWD)

Investigational drug(s) / intervention(s)

VGA039

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

Sex
ALL
Min age
12 Years
Max age
75 Years
Healthy volunteers
No
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)

Trial sites (32)

FacilityCityRegionStatus
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
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 the UK