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Von Willebrand Disease

Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease
NCT00941616 | PHASE 2 | INTERVENTIONAL

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 o

Trial Information
5 Sites
22 Participants
Recruiting
12 Years to 48 Months

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Study Site
Sofia,Bulgaria
Study Site
Warsaw,Poland
Study Site
Wroclaw,Poland
Study Site
Barnaul,Russian Federation
Study Site
Lviv,Ukraine,79044

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov