drugset / Trial / NCT01213446

Study of Biostate® in Children With Von Willebrand Disease

NCT01213446 ↗

Phase 3 Completed 17 enrolled CSL Behring Parexel · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-08
Primary completion
2013-08
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Biostate Protein / enzyme biologic 80 iu/kg Intravenous