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    Observational Study in Type 3 VWD (WILL-EMI NIS)

    Clinical Trial Overview

    An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment (WILL-EMI NIS)

    Objective

    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.

    VWD = von Willebrand disease; HRQoL = Health-related quality of life; SOC = standard of care; NIS = non-interventional study

    Primary Endpoints

    • Annualized Bleed Rate (ABR) for Treated Bleeds [Time Frame: From Baseline to at least 24 weeks]

    Secondary Endpoints

    • ABR for All Bleeds [Time Frame: From Baseline to at least 24 weeks]
    • ABR for Treated Spontaneous Bleeds [Time Frame: From Baseline to at least 24 weeks]
    • ABR for Treated Joint Bleeds [Time Frame: From Baseline to at least 24 weeks]
    • Incidence and Severity of Adverse Events, with Severity Determined According to the World Health Organization (WHO) Toxicity Grading Scale [Time Frame: From Baseline until study completion (at least 24 weeks)]

    VWD = von Willebrand disease
    ABR = Annualized Bleed Rate
    WHO = World Health Organization

    WP45335

    Modality: Non-interventional study

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    View on ClinicalTrials.gov

    Inclusion and Exclusion Criteria

    Key Inclusion Criteria Key Exclusion Criteria
    • Male and female participants Age >/= 2 years of age
    • 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
    • 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

    VWD = von Willebrand disease; SOC = Standard of care

    Enrollment & Resources

    Enrollment

    For more information on eligibility criteria, view the study or reach out to our team.

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    Web

    ClinicalTrials.gov
    Identifier: NCT06883240

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    Phone

    1-888-662-6728
    (US and Canada)

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    Email

    [email protected]

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    Clinical Trial Site Locations

    Clinical Trial Site Locations

    For more information on recruitment status, or where the study is being conducted

    Visit ClinicalTrials.gov

    Information is consistent with ClinicalTrials.gov as of December 12, 2025. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

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    TOP

    • ABR
      Annualized Bleed Rate

    • HRQoL
      Health-related quality of life

    • NIS
      non-interventional study

    • SOC
      Standard of care

    • VWD
      von Willebrand disease

    • WHO
      World Health Organization

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