Brief Title
Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
Official Title
An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B
Brief Summary
This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion
Secondary Outcome
Number of Infusions Required to Treat Each Bleed
Condition
Hemophilia B
Intervention
Benefix
Study Arms / Comparison Groups
Benefix
Description: Subjects received on-demand treatments with BeneFIX over a 6-month (calendar day) period.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
35
Start Date
February 2009
Completion Date
December 2009
Primary Completion Date
December 2009
Eligibility Criteria
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
Gender
All
Ages
6 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT00866606
Organization ID
3090A1-3305
Secondary IDs
B1821004
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
April 2011