- * Male subjects, 12 to 65 years old
- * Severe hemophilia B (FIX activity of ≤ 2%)
- * Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for \> 150 exposure days (EDs)
- * No history of FIX inhibitor formation, no detectable inhibitors at Screening and no family history of inhibitors against FIX
- * Written informed consent for study participation obtained before undergoing any study specific procedures
Hemophilia B
This study will examine the safety and efficacy of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B. The study consists of a screening period, a pharmacokinetic (PK) period, followed by approximately a 5 month treatment period. Subjects will receive weekly routine prophylactic therapy and on-demand treatment for bleeding episodes. In addition, subjects who are not on routine factor replacement therapy prior to the study will receive only on-demand treatment for bleeding episodes.
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Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov