Phase 4 study of Voncento in Subjects with Von Willebrand Disease
Research type
Research Study
Full title
An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease
IRAS ID
182620
Contact name
Pratima Chowdary
Contact email
Sponsor organisation
CSL Behring GmbH
Eudract number
2013-003305-25
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
This is a post-marketing study to further investigate the effectiveness and safety of Voncento in patients with Von Willebrand Disease (VWD) in whom treatment with a von Willebrand factor (VWF) product is required as on-demand therapy or during surgery. People with VWD have a deficiency of a factor in the blood which means that their blood cannot clot properly and they are prone to prolonged or excessive bleeding. The aim of therapy for the treatment of VWD is to reduce bleeding times. At least 20 participants over 12 years old will receive Voncento as required to manage their VWD over a treatment period of 12 months after the investigational product is initially dispensed to patients. Patients will be irregularly treated with Voncento when they need in case of non-surgical, spontaneous, or traumatic bleeding events or as a prevention treatment. Voncento will also be given to prevent and treat any surgical bleeding events. Voncento is expected to be a valuable addition to the current range of plasma derived replacement products.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/1087
Date of REC Opinion
7 Jul 2015
REC opinion
Favourable Opinion