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A Study to assess safety and effectiveness of Emicizumab in Patients with Type 3 Von Willebrand Disease
EU CTIS ID: 2024-515622-80-00
What this study is testing
To evaluate the efficacy of prophylactic emicizumab (i.e., administered on a scheduled basis with the intent to prevent bleeds) over time compared with on-demand standard of care (SOC) based on the superiority assessment of the following primary endpoint
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 2 years at the time of signing Informed Consent/Assent Form (Arm C)
- Adequate hematological function
- Documented exposure to on-demand and prophylactic SOC
- For patient with childbearing potential; agreement to adhere to the contraception requirements
- Confirmed diagnosis of Type 3 VWD, based on evaluation of VWF and FVIII levels
- Age ≥ 1 month at the time of signing Informed Consent/Assent Form (Arms A and B)
You likely can't join if
- Inherited or acquired bleeding disorder other than Congenital Type 3 VWD
- 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
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- United Kingdom
- United States
- Colombia
- Japan
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa; United Kingdom; United States; Colombia; Japan; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.