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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00076557
Eligibility Criteria:
* Males with severe hemophilia B with Factor IX activity level \< 1% of normal.
* Life expectancy of \> 1 year.
* Age \> 18 years old.
* Ability to give informed consent.
* Greater than twenty exposure days of treatment with Factor IX protein.
* No history or presence of an inhibitor to Factor IX protein.
* Subjects must be able to receive Factor IX protein on a home infusion protocol.
* Subjects must have a normal protime (PT).
* Hepatitis C infected subjects will be evaluated for liver fibrosis based on liver biopsy data graded on a scale of 0-4 (Poynard et. al., 1997). Subjects who are Hepatitis C antibody and RNA positive and have not had a liver biopsy within the last 36 months will be required to have one.
* Subjects must have low AAV titer.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00076557
Study Brief:
Protocol Section:
NCT00076557