Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT06883240

Active Not RecruitingN/A

Sponsor: Hoffmann-La Roche

Conditions: Von Willebrand Disease, Type 3

Interventions: Von Willebrand Factor Concentrates, Von Willebrand Factor Concentrates and Factor VIII Concentrates, Factor VIII Concentrates, Recombinant Activated Factor VII, Activated Prothrombin Complex Concentrate

Countries: United States, Belgium, Canada, Colombia, France, Germany, Italy, Japan

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 overview

Sex: ALL

Age: 2 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (26)
  • Sacramento, California, United States
  • Minneapolis, Minnesota, United States
  • St Louis, Missouri, United States
  • Leuven, Belgium
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Medellín, Colombia
  • Lille, France
  • Paris, France
  • Bonn, Germany
  • Duisburg, Germany
  • Frankfurt/M., Germany
  • Rome, Lazio, Italy
  • Milan, Lombardy, Italy
  • Florence, Tuscany, Italy
  • Fukuoka, Japan
  • Tokyo, Japan
  • Rotterdam, Netherlands
  • Warsaw, Poland
  • Johannesburg, South Africa
  • Madrid, Spain
  • Seville, Spain
  • Gothenburg, Sweden
  • London, United Kingdom
  • London, United Kingdom
  • Manchester, United Kingdom