A Study of Bleeding and Treatment in Participants With Von Willebrand Disease
NCT ID: NCT06610201
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-08-30
2026-06-30
Brief Summary
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Detailed Description
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The study includes screening, a baseline evaluation, and an approximately 4 month observation period which will include every other week telemedicine check-ins (to monitor bleed diary entries and bleeding event treatments. There will be an optional extension to the observation period of up to a total of 12 months for participants wishing to continue.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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VWD Type 1 (residual VWF antigen and/or activity less than 30 IU per dL)
Clinical outcomes of patients with VWD, Type 1
Accumulate information regarding bleeding events, quality of life, and the social and clinical impact of bleeding events in participants with VWD, Type 1
VWD Type 2A, Type 2M, Type 2N, or Type 3
Clinical outcomes of patients with VWD, Type 2A, Type 2M, Type 2N, or Type 3
Accumulate information regarding bleeding events, quality of life, and the social and clinical impact of bleeding events in participants with VWD, Type 2A, Type 2M, Type 2N and Type 3.
Interventions
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Clinical outcomes of patients with VWD, Type 1
Accumulate information regarding bleeding events, quality of life, and the social and clinical impact of bleeding events in participants with VWD, Type 1
Clinical outcomes of patients with VWD, Type 2A, Type 2M, Type 2N, or Type 3
Accumulate information regarding bleeding events, quality of life, and the social and clinical impact of bleeding events in participants with VWD, Type 2A, Type 2M, Type 2N and Type 3.
Eligibility Criteria
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Inclusion Criteria
2. Has an understanding, ability, and willingness to comply with Study procedures and restrictions.
3. ≥ 16 years at the time of screening.
5. Has symptomatic disease as defined by a history of bruising or bleeding events, with an expected minimum of 3 bleeding episodes (including heavy menstrual bleeding) per year that require treatment to control bleeding symptoms, and/or has recurrent and ongoing episodes of heavy menstrual bleeding at the time of enrollment.
Exclusion Criteria
2. Has a significant family history of unprovoked thromboembolic events in first degree relatives.
3. Has a congenital or acquired bleeding disorder other than VWD.
4. Has planned major surgery within the next 6 months.
5. Is pregnant or plans to become pregnant within the next 6 months.
6. Has any concurrent disease, treatment (including ongoing anticoagulation, antiplatelet, or non-steroidal anti-inflammatory drugs), condition, medication, or abnormality in clinical laboratory tests which may impact on the participant's bleeding symptoms or affect their ability to complete the study, in the Investigator's opinion.
7. Has received any investigational product within 30 days prior to screening. If the participant was enrolled and dosed in Velora Pioneer (study HMB-002-102; NCT06754852), they must have completed their End of Study Visit.
16 Years
ALL
No
Sponsors
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Hemab ApS
INDUSTRY
Responsible Party
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Principal Investigators
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VP of Clinical Research
Role: STUDY_DIRECTOR
Hemab ApS
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Emory Children's Center
Atlanta, Georgia, United States
Innovative Hematology, Inc./Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
University of Michigan Hospitals, Department of Hemophilia and Coagulation Disorders
Ann Arbor, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Oregon Health & Science University
Portland, Oregon, United States
Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvania, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Washington Institute For Coagulation (WIC)
Seattle, Washington, United States
Fiona Stanley Hospital
Murdoch, Perth, Australia
Royal Prince Alfred Hospital
Camperdown, Sydney, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Richmond Pharmacology
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HMB-002-101_SCR
Identifier Type: -
Identifier Source: org_study_id
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