Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc;
to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of
prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding
episodes between participants receiving rFIXFc on each prevention (prophylaxis) regimen and
participants receiving rFIXFc on an episodic regimen. The secondary objectives of the study
were: to evaluate and assess the pharmacokinetic (PK) parameter estimates of rFIXFc and rFIX
(BeneFIX®) at baseline in the Sequential PK subgroup as well as rFIXFc at Week 26 (±1 week);
to evaluate participants' response to treatment; to evaluate rFIXFc consumption.