The primary objective of the study is to evaluate the safety of rFIXFc (recombinant coagulation factor IX Fc fusion protein, BIIB029) in previously untreated participants with severe hemophilia B. Secondary objectives are to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes in previously untreated participants (PUPs), and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in previously untreated participants.
An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc; BIIB029) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia B
Weight>=3.5 kilogram at the time of informed consent
Severe hemophilia B defined as <=2 IU/dl (<=2%) endogenous factor IX documented in the medical record or as tested during the Screening Period.
Key Exclusion Criteria:
History of positive inhibitor testing. A prior history of inhibitors is defined based on a patient's historical positive inhibitor test using the local laboratory Bethesda value for a positive inhibitor test (that is equal to or above lower limit of detection)
History of hypersensitivity reactions associated with any Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc) administration
Exposure to blood components or injection with a coagulation factor IX (FIX)concentrate (including plasma derived) other than rFIXFc
Injection with commercially available rFIXFc more than 28 days prior to Screening
More than 3 injections of commercially available rFIXFc prior to confirmation of eligibility
Other coagulation disorders in addition to hemophilia B
Any concurrent clinically significant major disease that, in the opinion of the Investigator, would make the subject unsuitable for enrollment (example HIV infection with CD4 lymphocyte count less than (<)200 cells/microliter (mcL) or a viral load greater than (>)200 particles/mcL, or any other known congenital or acquired immunodeficiency)
Current systemic treatment with chemotherapy and/or other immunosuppressant drugs.Use of steroids for treatment of asthma or management of acute allergic episodes or otherwise life-threatening episodes is allowed. Treatment in these circumstances should not exceed a 14-day duration
Participation within the past 30 days in any other clinical study involving investigational treatment
Current enrollment in any other clinical study involving investigational treatment
Inability to comply with study requirements
Other unspecified reasons that, in the opinion of the Investigator or Bioverativ,make the subject unsuitable for enrollment
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Research Sitenot yet accepting patients San Francisco, California, 94143, United States
Research Sitenot yet accepting patients Sacramento, California, 95817, United States
Research Siteaccepting new patients Torrance, California, 90502, United States