071101: rVWF in Subjects with Severe VWD Undergoing Surgery
Research type
Research Study
Full title
A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE
IRAS ID
166262
Contact name
Thynn Thynn Yee
Contact email
Sponsor organisation
Baxter Innovations GmbH
Eudract number
2014-003575-38
Duration of Study in the UK
1 years, 7 months, 26 days
Research summary
This study is for a new drug called rVWF in participants with hereditary severe Von Willebrand Disease (VWD) undergoing major and minor elective surgical procedures. People with VWD have a deficiency of a blood protein called Von Willebrand factor, or it doesn't work properly. This means that their blood doesn’t clot properly and they are prone to prolonged or excessive bleeding. In addition to the study drug rVWF, participants may also receive rFVIII which is a licensed medication called ADVATE®. This is an open-label study which means that participants and the study doctor will know what treatment the participant is receiving. The dose of rVWF and ADVATE participants receive and how often treatment is administered will depend on the type of VWD they have, the level of the clotting factors detected in their blood and the type of surgery they are due to undergo.
The main goals of the study are:
1) to find out if receiving rVWF by itself or in combination with ADVATE improves the ability of the blood to clot.
2) to look at how safe it is to receive rVWF by itself or in combination with ADVATE and what symptoms and side effects participants have while taking it.
3) to examine the levels of rVWF and ADVATE in the blood over time and see what happens to the drug once it is in the blood stream.
4) to examine the impact of taking rVWF by itself or in combination with ADVATE on participants’ quality of life.
Around 15 people with VWD will participate in this study. The study will be done worldwide including, Australia, Europe, Latin America, Russia, Turkey and the US. Participants will be in this study for about 8-15 weeks.REC name
London - Hampstead Research Ethics Committee
REC reference
14/LO/2179
Date of REC Opinion
15 Jan 2015
REC opinion
Further Information Favourable Opinion