Trials / Completed
CompletedNCT01229007
Study of Biostate® in Children With Hemophilia A
A Phase III, Open-Label, Multicentre Study to Evaluate Efficacy, Pharmacokinetics, and Safety of Biostate® in Paediatric Subjects With Haemophilia A
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- Male
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the efficacy and safety of a Von Willebrand Factor/Factor VIII (VWF/FVIII), Biostate, and to investigate the pharmacokinetics of Biostate in children with haemophilia A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Biostate | 1 dose of 50 IU FVIII/kg body weight of Biostate administered intravenously on Day 1 in the PK component, followed by the Efficacy component for continuation of Biostate therapy, as required for a minimum of 50 exposure days. |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2014-07-01
- Completion
- 2014-07-01
- First posted
- 2010-10-27
- Last updated
- 2017-08-24
Locations
8 sites across 6 countries: Belarus, Georgia, Guatemala, Lebanon, Mexico, Ukraine
Source: ClinicalTrials.gov record NCT01229007. Inclusion in this directory is not an endorsement.