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:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT04108260
Eligibility Criteria:
Inclusion Criteria:
* Male patients with age ≥ 20 years old
* Endogenous FIX activity ≤1 IU/dL,
* At least 50 exposure days (EDs) with FIX products,
* No detectable inhibitor to FIX or inhibitor history,
* Had a minimum of 2 nontrauma-induced bleeding episodes (any type or location) treated in the 6 months preceding study entry,
* The patient or patient's parents or legal authorized representative, as applicable, are capable to understand the study objectives and procedure, and sign the written consent,
* Accept that the supply of Idelvion might be stopped once the study is completed,
* Able to complete a diary during 12 months or 50 EDs, whichever comes first.
Exclusion Criteria:
* Currently participating in an interventional clinical trial,
* Known hypersensitivity to any FIX product or hamster protein,
* Known inhibitor to FIX or inhibitor history,
* With other comorbidities which are not suitable for this study, at investigator's discretion,
* Not able to compliant with the prophylactic treatment,
* Lacking previous treatment and bleeding records.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT04108260
Study Brief:
Protocol Section:
NCT04108260