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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT01386268
Eligibility Criteria:
Inclusion Criteria:
* Patients with diagnosis of hemophilia A
* Treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS
* Signed the informed consent form to participate in this study.
* For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available
* For pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available
* For patients with no available inhibitor status, it should be checked as per the recommendation of KFDA
* Patients are defined as included in the study if there is a documented prescription of KOGENATE FS by the physician.
Exclusion Criteria:
* Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01386268
Study Brief:
Protocol Section:
NCT01386268