The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).

Condition	Treatment or Intervention	Phase
Hemophilia B	Drug: rFIX	Phase III

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Hemophilia B (FIX:C ≤2%)
• Previous treatment of at least 150 exposure days using any FIX product
• ≥12 years of age
• If female and of childbearing age, willing to use appropriate birth control measures
• In the investigator’s judgment, the patient and/or parent/legal guardian will be compliant and ensure adequate follow-up
• The patient and/or parent/legal guardian has voluntarily signed and dated informed consent document and provided assent, if applicable, prior to any screening procedures.

Exclusion Criteria:

• The patient has a currently detectable factor IX inhibitor (≥ 0.6 BU) or a history of inhibitors. A family history of inhibitors will not exclude the patient.
• Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins
• Patient has a genetic coagulation disorder other than hemophilia B
• Patient has received an investigational drug within 30 days of entering the study
• Patient has any condition (medical or social) that, in the investigator's judgment, makes participation in the study not advisable, including history of substance abuse

California
      Children's Hospital of Los Angeles, Los Angeles,  California,  90027,  United States; Recruiting
Colorado
      University of Colorado Health and Science Center, Aurora,  Colorado,  80262,  United States; Recruiting
Michigan
      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States; Recruiting
New Jersey
      Robert Wood Johnson Medical School, New Brunswick,  New Jersey,  08903,  United States; Recruiting
North Carolina
      Comprehensive Hemophilia Center, Chapel Hill,  North Carolina,  27599-7016,  United States; Recruiting
Ohio
      Children's Medical Center, Dayton,  Ohio,  45404,  United States; Recruiting
Texas
      University of Texas Houston Medical School, Houston,  Texas,  77030,  United States; Recruiting

Study ID Numbers:  3090A1-302-WW
Record last reviewed:  January 2005
Last Updated:  January 27, 2005
Record first received:  October 4, 2004
ClinicalTrials.gov Identifier:  NCT00093171
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08