drugset / Trial / NCT01213446
Study of Biostate® in Children With Von Willebrand Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Biostate | Protein / enzyme biologic | 80 iu/kg | Intravenous |