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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT00623727
Eligibility Criteria:
Inclusion Criteria:
* Males aged 12 to 70 years
* Subjects with severe hemophilia A (\< 1% factor VIII \[FVIII\]:C)
* Subjects with equal or greater than 150 exposure days (EDs) with any FVIII in total
* Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule
* Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records
* Subjects with no measurable inhibitor activity
* Subjects with no history of FVIII inhibitor antibody formation
* Written informed consent by subject and parent / legal representative, if \< 18 years
Exclusion Criteria:
* Subjects who are receiving primary prophylaxis
* Subjects on prophylaxis with documented requirements of \> 75 IU/kg/week
* Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
* Subjects with abnormal renal function
* Subjects with elevated hepatic transaminases
* Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study
* Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG)
* Subjects who require any pre-medication for FVIII injections
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
12 Years
Maximum Age:
70 Years
Study:
NCT00623727
Study Brief:
Protocol Section:
NCT00623727