An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
NCT ID: NCT06883240
Last Updated: 2025-12-23
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
40 participants
OBSERVATIONAL
2025-04-29
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with Type 3 VWD Treated with Prophylactic SOC
Participants with Type 3 VWD, aged 2 years and above, who are currently on standard of care (SOC) prophylactic therapy are anticipated to remain on the chosen SOC regimen during the study. Dosing and treatment duration of any studied medicinal products collected as part of this study are at the discretion of the treating physician in accordance with local labeling or local treatment guidelines.
Von Willebrand Factor Concentrates
Used according to local labeling or local treatment guidelines.
Von Willebrand Factor Concentrates and Factor VIII Concentrates
Used according to local labeling or local treatment guidelines.
Factor VIII Concentrates
Used according to local labeling or local treatment guidelines.
Recombinant Activated Factor VII
Used according to local labeling or local treatment guidelines.
Activated Prothrombin Complex Concentrate
Used according to local labeling or local treatment guidelines.
Interventions
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Von Willebrand Factor Concentrates
Used according to local labeling or local treatment guidelines.
Von Willebrand Factor Concentrates and Factor VIII Concentrates
Used according to local labeling or local treatment guidelines.
Factor VIII Concentrates
Used according to local labeling or local treatment guidelines.
Recombinant Activated Factor VII
Used according to local labeling or local treatment guidelines.
Activated Prothrombin Complex Concentrate
Used according to local labeling or local treatment guidelines.
Eligibility Criteria
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Inclusion Criteria
* Adequate hematologic, hepatic, and renal function
* Documented and confirmed previous use of SOC prophylactic therapy for VWD (1-3 times weekly, as per prescribed dose) and anticipation to remain on the same regimen during the study
* For participants of childbearing potential: agreement to remain abstinent or adhere to the contraception requirements
Exclusion Criteria
* History of gastrointestinal bleeding within 18 months prior to enrollment, or any previous diagnosis of angiodysplasia
* History of intracranial hemorrhage
* Previous or current treatment for thromboembolic disease or signs of thromboembolic disease
* Other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis
* History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
* Use of systemic immunomodulators (e.g., interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy
2 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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UC Davis
Sacramento, California, United States
University of Florida
Gainesville, Florida, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
UZ Leuven Gasthuisberg
Leuven, , Belgium
The Hospital for Sick Children
Toronto, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
IPS SURA Industriales Medellín
Medellín, , Colombia
Hopital Claude Huriez - CHU Lille
Lille, , France
Groupe Hospitalier Necker Enfants Malades
Paris, , France
Universitätsklinikum Bonn
Bonn, , Germany
Gerinnungszentrum Rhein-Ruhr;Gerinnungsambulanz
Duisburg, , Germany
Hämophiliezentrum Med. Klinik III/Institut für Transfusionsmedizin
Frankfurt/M., , Germany
Universita' Degli Studi La Sapienza-Ist.Di Ematologia
Rome, Lazio, Italy
IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
AOU Careggi
Florence, Tuscany, Italy
Kurume University Hospital
Fukuoka, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Erasmus MC
Rotterdam, , Netherlands
Instytut Hematologii i Transfuzjologii
Warsaw, , Poland
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, , South Africa
Hospital Universitario la Paz
Madrid, , Spain
Hospital Universtiario Virgen del Rocio
Seville, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
St Thomas' Hospital
London, , United Kingdom
Great Ormond Street Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: WP45335 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. Only)
Email: [email protected]
Other Identifiers
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WP45335
Identifier Type: -
Identifier Source: org_study_id