Study of Biostate® in Children With Von Willebrand Disease

Status Completed

Clinical Trial Summary

This is an open-label study to investigate the pharmacokinetics (PK), efficacy, and safety of a von Willebrand Factor/Factor VIII (VWF/FVIII), Biostate, in children with Von Willebrand disease (VWD) in whom treatment with a VWF product is required for prophylactic therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic bleeding event.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01213446
Study type	Interventional
Source	CSL Behring
Contact
Status	Completed
Phase	Phase 3
Start date	August 2010
Completion date	August 2013

View Details

See also
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Completed	`NCT01224808` - Extension Study of Biostate in Subjects With Von Willebrand Disease	Phase 3
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Completed	`NCT00805051` - Acquired Von Willebrand Syndrome in Severe Aortic Stenosis	N/A
Completed	`NCT00168090` - Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)	Phase 4
Completed	`NCT02246881` - A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.	Phase 3
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Completed	`NCT02973087` - rVWF IN PROPHYLAXIS	Phase 3
Completed	`NCT01410227` - Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)	Phase 3
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Completed	`NCT01589848` - Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador	N/A
Completed	`NCT00941616` - Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease	Phase 2/Phase 3
Completed	`NCT00557908` - The Von Willebrand Disease (VWD) International Prophylaxis Study	N/A