Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B
This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.
Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion
Number of Infusions Required to Treat Each Bleed
Study Arms / Comparison Groups
Description: Subjects received on-demand treatments with BeneFIX over a 6-month (calendar day) period.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria: - Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B (FIX activity: more than 5%, 1-5%, or less than 1%, respectively) - Subjects with previous exposure to FIX replacement therapy - If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry Exclusion Criteria: - Diagnosed with any bleeding disorder in addition to hemophilia B - Current FIX inhibitor or history of FIX inhibitor (defined as >ULN of the reporting laboratory) - Subject has no history of exposure to FIX products (previously untreated patient [PUP]) - Subject is currently utilizing primary FIX prophylaxis - Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry - Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation - Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation - Subjects with a known hypersensitivity to hamster protein - Significant hepatic or renal impairment (ALT and AST >5 x ULN, bilirubin >2 mg/dL or serum creatinine >1.25 x ULN) - Prothrombin Time >1.5 x ULN - Platelet count <80,000/µL - Pregnant or breastfeeding women - Unwilling or unable to follow the terms of the protocol - Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor
6 Years - N/A
Accepts Healthy Volunteers
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