TAK-577-3001
Research type
Research Study
Full title
A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis with Vonicog Alfa (rVWF) in Children Diagnosed With Severe von Willebrand Disease
IRAS ID
1012981
Contact name
John Vaughan
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc
Clinicaltrials.gov Identifier
Research summary
The study is for children with severe von Willebrand disease (VWD), who have had treatment for this disease. These children have bleeding that happens suddenly and has no known cause, such as a nosebleed. They can also have bleeding that may happen because of a trauma, such as an accident. Most treatments for these children involve treating and slowing down bleeds that already happened. This is known as “on-demand” treatment.
For this study, the study drug is used to stop a bleed before it happens (to prevent a bleed or the medical term is known as “prophylactic”). Instead of treating a bleed that happened, it is hoped that the study drug will help prevent bleeding before it starts.
This study is going to look at how well the study drug (recombinant von Willebrand factor (rVWF), works to prevent and control bleeding.REC name
East of Scotland Research Ethics Service REC 2
REC reference
25/ES/0115
Date of REC Opinion
6 Feb 2026
REC opinion
Further Information Favourable Opinion