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:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-24 @ 11:46 AM
NCT ID:
NCT01335061
Eligibility Criteria:
Inclusion Criteria:
* Documented history of moderately-severe to severe hemophilia B (FIX activity \</=2%).
* Male subjects, aged 12 years to 65 years.
* Subjects with at least 100 exposure days (EDs) to factor IX products.
* Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12-month period before the Screening visit.
Exclusion Criteria:
* Subjects who have received FIX as a primary or secondary prophylaxis regimen within the last 12 months prior to the Screening visit.
* Subjects who have had major surgery or an orthopedic surgical procedure within the past 3 months prior to Screening visit.
* Subjects for which major surgery or orthopedic surgery is planned within the duration of study participation.
* Subjects with a past history of, or current FIX inhibitor, defined as \>ULN (upper limit of normal) of the reporting laboratory.
* Subjects with a known hypersensitivity to any FIX product or hamster protein.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT01335061
Study Brief:
Protocol Section:
NCT01335061