This study will investigate the pharmacokinetics (PK), efficacy, and safety of rIX-FP for the routine prophylaxis of bleeding episodes in male Chinese previously treated patients (PTPs) with hemophilia B (FIX activity of ≤ 2%). In addition to the scheduled rIX-FP prophylaxis regimen, subjects may also receive rIX-FP episodic (on-demand) treatment for breakthrough bleeding episodes and rIX-FP for the prophylaxis and treatment of bleeding in emergency surgical procedures.
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Incremental recovery (IR) (plasma FIX activity)
Timeframe: Before, and at 30 minutes after the end of, rIX-FP infusion on Day 1
Maximum plasma concentration (Cmax)
Timeframe: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1
Terminal elimination half-life (t1/2) of rIX-FP
Timeframe: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1
Area under the concentration-time curve (AUC)
Timeframe: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1
Clearance (Cl) of rIX-FP
Timeframe: Before, and up to 336 hours after the end of, rIX-FP infusion on Day 1
Annualized spontaneous bleeding rate (AsBR)
Timeframe: Up to 18 months
Number of subjects who develop an inhibitor to FIX
Timeframe: Up to 18 months after rIX-FP infusion