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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT02213250
Eligibility Criteria:
Inclusion Criteria:
* Male Chinese subjects 6 years or older (weight ≥20kg) with moderate to severe hemophilia B (Factor IX activity ≤2%).
* Subjects should not have received an infusion of any Factor IX products for at least 4 days before the administration of BeneFIX on Day 1.
* Subjects must be in a non-bleeding state before the administration of BeneFIX on Day 1.
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Diagnosed with any other bleeding disorder in addition to hemophilia B.
* Current FIX inhibitor or history of FIX inhibitor (defined as \> Upper Limit of Normal (ULN) of the reporting lab).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
6 Years
Study:
NCT02213250
Study Brief:
Protocol Section:
NCT02213250