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Recruiting
NCT06883240
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Conditions: Von Willebrand Disease, Type 3
Sex: All
Ages: 2 Years – N/A
Healthy volunteers: No
Enrollment: 40
Sponsor: Hoffmann-La Roche
Location: UC Davis Sacramento California
Summary
This non-interventional study (NIS) is designed to collect information on the effectiveness and safety of treatment received in routine clinical care, as well as measure the health-related quality of life (HRQoL) of participants with Type 3 von Willebrand disease (VWD) receiving prophylactic therapy per local standard of care (SOC) over an observation period of at least 24 weeks.
Eligibility Criteria
Inclusion Criteria:
* Confirmed diagnosis of Type 3 von Willebrand disease (VWD), based on medical records
* 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:
* Inherited or acquired bleeding disorder other than Congenital Type 3 VWD
* 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
Source: ClinicalTrials.gov (NCT06883240). StuddyBuddy aggregates publicly available trial information.