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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT01034904
Eligibility Criteria:
Inclusion Criteria:
* Moderate or severe Hemophilia A (factor level ≤5%)
* Receiving Helixate FS as on-demand treatment or prophylaxis therapy at time of informed consent
* Patient age 14 to 29 years at the time of recruitment
* Complete informed consent process and documentation; (Patients under age 18 must assent in addition to consent of legal guardian)
* Willing/able to follow study protocol, including keeping a bleeding and treatment diary
* Able to communicate clearly in either English or French - both written and verbal communication is essential.
Exclusion Criteria:
* Known inhibitor at time of recruitment (\> 0,5 Bethesda units) or immune tolerance therapy at time of recruitment
* HIV positive
* Symptomatic Hepatitis B or C infection or active treatment for hepatitis B or C
* Inability to comply with study protocol
* Hypersensitivity to Helixate FS or to any ingredients in the formulation or component of the container
* Hypersensitivity to mouse or hamster protein
* Unsuitable to participate in study for any other reason as assessed by investigator
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
14 Years
Maximum Age:
30 Years
Study:
NCT01034904
Study Brief:
Protocol Section:
NCT01034904