An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment

  • Blood Disorder
  • Blood platelet disorder
  • Von Willebrand disease (VWD)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Not yet recruiting

This study runs in
N/A
Study Identifier:

NCT06883240 WP45335

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study 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.

      Hoffmann-La Roche Sponsor
      N/A Phase
      NCT06883240, WP45335 Study Identifier
      Von Willebrand Factor Concentrates, Von Willebrand Factor Concentrates and Factor VIII Concentrates, Factor VIII Concentrates, Recombinant Activated Factor VII, Activated Prothrombin Complex Concentrate Treatments
      Von Willebrand Disease, Type 3 Condition
      Official Title

      A Multicenter Non-Interventional Study Evaluating Bleeds and Health-Related Quality Of Life in Patients With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment

      Eligibility Criteria

      All Gender
      ≥2 Years Age
      No Healthy Volunteers
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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