Von Willebrand Disease Clinical Trial
Official title:
An Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy and Safety of Biostate® in Subjects With Von Willebrand Disease.
The aim of this study is to assess the pharmacokinetics (PK), efficacy, and safety of
Biostate® in subjects with Von Willebrand Disease (VWD).
Pharmacokinetic Component:
PK parameters will be determined from a subgroup of subjects. Subjects who complete the PK
component will subsequently continue in the efficacy component of the study, either
continuing on a previously established prophylaxis regimen or continuing to receive on-demand
treatment with the occurrence of non-surgical bleeding (NSB) events.
Efficacy Component:
Three treatment arms are defined for the efficacy component of the study. (1) Subjects who
are currently being treated on a set prophylaxis regimen with a VWF product at the time of
study entry will be enrolled in the "Prophylaxis" arm. (2) Subjects not being treated on a
set prophylaxis regimen at the time of study entry who require a VWF product for the
treatment of NSB events will be enrolled in the "On-demand" arm and commence using Biostate
in the treatment of NSB events. (3) Subjects enrolled in the "On-demand" arm have the
possibility to enter the "Cross-over to Prophylaxis" arm to receive an additional 12 months
of prophylactic treatment.
n/a
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