Actively Recruiting
Velora Discover: A Prospective, Screening 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people with Von Willebrand Disease (VWD), focusing on how often bleeding events happen, their impact on quality of life, and the social and clinical effects of bleeds. This screening study gathers baseline data on bleeding and treatment rates in participants with VWD, mainly Type 1, but may include Types 2 and 3 with sponsor approval. The findings will help compare outcomes in future clinical studies like Velora Pioneer. The study involves screening and a baseline check, followed by an observation period of about 4 months during which participants will have telemedicine check-ins every two weeks. These check-ins monitor bleeding events and treatment use through a bleed diary. Participants can opt to extend this observation period up to 12 months if they wish. Participants will provide information about their bleeding events and treatments during the study. Researchers will assess bleeding rates, hospital stays, and quality of life using questionnaires and clinical evaluations. Outcomes measured include annual bleeding rates, treatment use, iron status, and bleeding severity scores. The study concludes with data collection over the observation period, helping to understand the experience of people with VWD over time.
CONDITIONS
Brief 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 comply with study procedures
- Age between 16 and under 70 years at screening
- Weight between 50 and 120 kg (±10%) and BMI less than 38.5 kg/m²
- Diagnosed with Type 1 (including Type 1C) or Type 2A Von Willebrand Disease confirmed by lab results
- History of bleeding symptoms with at least 3 bleeding episodes per year requiring treatment or ongoing heavy menstrual bleeding at enrollment
You will not qualify if you...
- History of significant allergic reactions to monoclonal antibody therapies
- Personal history of venous or arterial thrombosis except certain superficial vein thrombosis
- High-risk thrombophilia conditions such as homozygous Factor V Leiden or congenital protein deficiencies
- Need for ongoing bleed-prevention treatment
- Other severe bleeding disorders besides Von Willebrand Disease
- Planned major surgery during the study period
- Conditions increasing thrombosis risk including obesity, reduced mobility, active cancer, recent surgery or childbirth
- Pregnancy or plans to become pregnant within 6 months after consent
- Significant cardiovascular diseases including heart failure, coronary artery disease, arrhythmias, and stroke
- Other risk factors increasing cardiovascular event risk like smoking or uncontrolled hypertension
- Concurrent diseases, treatments, or medications affecting bleeding or study completion
- Participation in investigational product studies within 30 days prior to screening or recent participation in related Velora Pioneer study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants undergo baseline evaluation including confirmation of Von Willebrand Disease type and bleeding history.
1 baseline visit (in-person)
Duration - Approximately 4 months with optional extension up to 12 months
Participants are observed approximately 4 months with regular telemedicine check-ins to monitor bleeding events and treatments. An optional extension up to 12 months is available for those wishing to continue.
Biweekly telemedicine check-ins
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)
C
Clinical Trials (Australia)
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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