Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT00866606
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT00866606
Study Brief:
Protocol Section:
NCT00866606