NCT01224808

Extension Study of Biostate in Subjects With Von Willebrand Disease

An Open-Label, Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate® in Paediatric, Adolescent, and Adult Subjects With Von Willebrand Disease Who Completed Clinical Studies CSLCT-BIO-08-52 or CSLCTBIO-08-54

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The aim of the Von Willebrand Disease (VWD) therapy is to treat and prevent bleeding episodes due to abnormal platelet adhesion and abnormal blood coagulation as a result of low or abnormal Von Willebrand Factor (VWF) and/or Factor VIII (FVIII) levels. The long-term efficacy and safety of a VWF/FVIII concentrate, Biostate, will be investigated in children, adolescents, and adults with 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	Single bolus doses, administered intravenously. Frequency and dose will be determined by the Investigator based on the subjects clinical condition, previous VWF concentrate requirements, response to therapy, weight and reason for usage.

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2010-10-20
• Last updated: 2017-10-03

Locations

6 sites across 5 countries: Bulgaria, Germany, Poland, Russia, Ukraine