NCT02461992

Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A

An Open-label, Single Dose Pharmacokinetic Study Of Xyntha (Moroctocog Alfa (Af-cc), Recombinant Factor Viii) In Male Chinese Subjects With Hemophilia A

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 6 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hemophilia A

Interventions

Type	Name	Description
DRUG	Intravenous infusions of Xyntha	A single dose 50IU/kg dose of Xyntha administered by intravenous infusion within 10 minutes on Day 1

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-06-03
• Last updated: 2016-09-07
• Results posted: 2016-06-15

Locations

2 sites across 1 country: China