RECRUITING

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

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Conditions

Von Willebrand Disease, Type 3

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-04-29
Study Completion:2026-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06883240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of Type 3 von Willebrand disease (VWD), based on medical records
  2. * Adequate hematologic, hepatic, and renal function
  3. * 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
  4. * For participants of childbearing potential: agreement to remain abstinent or adhere to the contraception requirements
  1. * Inherited or acquired bleeding disorder other than Congenital Type 3 VWD
  2. * History of gastrointestinal bleeding within 18 months prior to enrollment, or any previous diagnosis of angiodysplasia
  3. * History of intracranial hemorrhage
  4. * Previous or current treatment for thromboembolic disease or signs of thromboembolic disease
  5. * Other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis
  6. * History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
  7. * Use of systemic immunomodulators (e.g., interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy

Contacts and Locations

Study Contact

Reference Study ID Number: WP45335 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

UC Davis
Sacramento, California, 95817
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-29
Study Completion Date2026-11-01

Study Record Updates

Study Start Date2025-04-29
Study Completion Date2026-11-01

Terms related to this study

Additional Relevant MeSH Terms

  • Von Willebrand Disease, Type 3