NCT01213446

Study of Biostate® in Children With Von Willebrand Disease

A Phase III Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy, and Safety of Biostate® in Paediatric Subjects With Von Willebrand Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Von Willebrand Disease

Interventions

Type	Name	Description
BIOLOGICAL	Biostate	PK component: Single bolus infusion of 80 IU VWF:RCo/kg administered intravenously on Day 1, and approximately Day 180 in Type 3 VWD subjects only. Efficacy component: Repeated bolus doses over 12 months as required to manage VWD condition.

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-10-04
• Last updated: 2017-10-03

Locations

7 sites across 6 countries: Belarus, Georgia, Germany, Guatemala, Lebanon, Ukraine