drugset / Trial / NCT01224808

Extension Study of Biostate in Subjects With Von Willebrand Disease

NCT01224808 ↗

Phase 3 Completed 20 enrolled CSL Behring
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-10
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Biostate Protein / enzyme biologic — Intravenous