Actively Recruiting
A Study of Bleeding and Treatment in Participants With Von Willebrand Disease
Led by Hemab ApS · Updated on 2026-04-21
200
Participants Needed
17
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this screening study is to accumulate information regarding bleeding events, quality of life, and the social and clinical impact of bleeds in participants with Von Willebrand Disease (VWD). Data from this study will be used to establish baseline bleeding and treatment rates in a population of participants with VWD and act as comparator data for future clinical study outcomes.(e.g. Velora Pioneer)
CONDITIONS
Official Title
A Study of Bleeding and Treatment in Participants With Von Willebrand Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent according to regulations
- Willingness and ability to follow study procedures and restrictions
- Age between 16 and under 70 years at screening
- Body weight between 50 and 120 kg (±10%) and body mass index (BMI) under 38.5 kg/m2
- Diagnosed with Type 1 VWD (including Type 1C) or Type 2A VWD with documented lab results and VWF Activity ≤30 IU/dL and FVIII activity ≤70 IU/dL at screening
- History of bruising or bleeding with at least 3 bleeding episodes (including heavy menstrual bleeding) per year needing treatment, or ongoing heavy menstrual bleeding at enrollment
You will not qualify if you...
- History of severe allergic reactions to monoclonal antibody therapies
- Personal history of venous or arterial thrombosis or thromboembolic disease, except catheter-associated superficial vein thrombosis
- High-risk thrombophilia such as homozygous Factor V Leiden, compound heterozygous FVL/prothrombin gene mutation, antithrombin <50%, or congenital protein C or S deficiency <50%
- Requires ongoing prophylactic treatment to prevent bleeding
- Presence of other severe bleeding disorders besides VWD
- Planned major surgery during the study period
- Conditions increasing thrombosis risk including significant family history, BMI >30 and ≤38.5 kg/m2, reduced mobility, active cancer, recent major surgery or childbirth
- Pregnancy or plans to become pregnant within 6 months after consent
- Clinically significant cardiovascular disease including severe heart failure, coronary artery disease, uncontrolled arrhythmia, moderate to severe valve disease, peripheral vascular disease, or ischemic stroke
- Other conditions increasing cardiovascular risk such as smoking, uncontrolled high cholesterol, or uncontrolled high blood pressure
- Any other disease, treatment, medication, or lab abnormalities impacting bleeding or study completion as judged by the investigator
- Use of investigational products within 30 days prior to screening or recent participation in a related study without completion of end-of-study visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Actively Recruiting
3
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
4
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
5
Emory Children's Center
Atlanta, Georgia, United States, 30329
Actively Recruiting
6
Innovative Hematology, Inc./Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, United States, 46260
Actively Recruiting
7
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112-2699
Actively Recruiting
8
University of Michigan Hospitals, Department of Hemophilia and Coagulation Disorders
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
10
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Actively Recruiting
11
Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
12
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
13
Washington Institute For Coagulation (WIC)
Seattle, Washington, United States, 98101
Actively Recruiting
14
Fiona Stanley Hospital
Murdoch, Perth, Australia, WA 6150
Actively Recruiting
15
Royal Prince Alfred Hospital
Camperdown, Sydney, Australia, NSW 2050
Actively Recruiting
16
The Alfred Hospital
Melbourne, Victoria, Australia, VIC 3004
Actively Recruiting
17
Richmond Pharmacology
London, United Kingdom, SE1 1YR
Actively Recruiting
Research Team
C
Clinical Trials (USA; UK)
CONTACT
C
Clinical Trials (Australia)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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