Screening Study of Bleeding & Treatment in Participants with VWD
Research type
Research Study
Full title
A Prospective, Screening Study of Bleeding and Treatment in Participants with Von Willebrand Disease
IRAS ID
346002
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Hemab ApS
Duration of Study in the UK
1 years, 6 months, 16 days
Research summary
Von Willebrand disease (VWD) is an inherited bleeding disorder, characterised by bleeding events that range from frequent, low-volume bleeding events, that impact quality of life to large-volume bleeding events that are life-threatening.
A screening study is being conducted to gather information on bleeding events, quality of life and the social and clinical impact of bleeds in participants with Von Willebrand disease (VWD) to provide a comparison for future clinical studies. The study will also inform the choice of study assessments to be used in future treatment studies and identify potential study participants.
The study includes screening, a baseline evaluation on Day 1, an observational period of 4-6 months and an optional extension to the observational period of up to 12 months. The study will take approximately 4.5 to 12.5 months to complete (including an optional extension to the observational period) for each participant. The observational period will include phone calls or messages with the study staff to support and monitor the bleed diary and bleeding event treatment record. Participants will be required to have in-person clinic visits every 12 weeks for blood samples to be taken.
REC name
London - Riverside Research Ethics Committee
REC reference
24/LO/0613
Date of REC Opinion
22 Aug 2024
REC opinion
Further Information Favourable Opinion