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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT02581969
Eligibility Criteria:
Inclusion Criteria:
* Completion of follow-up in the original Potter study without having being excluded from the Intention To Treat efficacy analysis of the primary endpoint;
* Written informed consent specifically issued for the 5-year extension.
Exclusion Criteria:
* Switching of treatment to a Factor VIII concentrate different from Kogenate Bayer/Helixate NexGen after the end of the previous follow-up period.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
17 Years
Maximum Age:
60 Years
Study:
NCT02581969
Study Brief:
Protocol Section:
NCT02581969