Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects With Hemophilia B

Inclusion Criteria

• •1. Subject's parent or legal guardian must give written Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent and be willing to make the required study visits and follow instructions while enrolled in the study. For subjects ≥7 years of age, assent will be obtained if required by the institution. For subjects \< 7 years of age, legal assent is not reasonable to obtain.
• •2. Severe (factor IX activity ≤2 IU/dL) hemophilia B subjects currently on-demand therapy with a minimum of 2 bleeding episodes requiring factor IX therapy over the preceding 6 months or 4 bleeding episodes over the preceding 12 months; subjects on prophylaxis with a bleeding pattern similar to that above demonstrated prior to starting prophylaxis
• •3. Immunocompetent (CD4 count \>400/mm3) and not receiving immune modulating or chemotherapeutic agents
• •4. Previously treated patients with a minimum of 50 exposure days to a factor IX preparation
• •5. Platelet count at least 150,000/mm3
• •6. Liver function: alanine transaminase \[ALT\] and aspartate transaminase \[AST\] ≤2 times the upper limit of the normal range
• •7. Total bilirubin ≤1.5 times the upper limit of the normal range
• •8. Renal function: serum creatinine ≤1.25 times the upper limit of the normal range
• •9. Willingness to participate in the trial for approximately 6 months (50 exposures)
• •10. Age ≤12 years
• •11. Hemoglobin ≥7 g/dL at the time of the blood draw