Conditions: Hemophilia A
Keywords: FVIII activity
Enrollment: 13
Healthy volunteers: no

Brief summary:
An open-label, single dose pharmacokinetic study of Xyntha (Moroctocog Alfa (AF-CC), Recombinant Factor VIII) in male Chinese subjects with hemophilia A

Detailed description:
The purpose of this study is to obtain pharmacokinetic profiles of FVIII:C after Xyntha administration in Chinese patients with severe hemophilia A, which is in support of the continued registration of Xyntha in China

Arms:
arm 1: observation arm

Interventions: intervention 1: Intravenous infusions of Xyntha
Intervention descriptions: intervention 1: A single dose 50IU/kg dose of Xyntha administered by intravenous infusion within 10 minutes on Day 1

Protocol document: