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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT07088458
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of hemophilia A
* Patients must be 7 to \< 12 years of age at enrollment
* Patients previously treated for hemophilia A ((≥50 exposure days to FVIII)
* No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
* Patients without a previous history of inhibitors or patients with a previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry
* Initiation of prescription or currently prescribed damoctocog alfa pegol for regular continuous prophylaxis (intent to treat for 52 weeks/year)
* Signed informed consent/assent.
Exclusion Criteria:
* Presence of a FVIII inhibitor
* Concurrent participation in an investigational program with interventions outside of routine clinical practice
* Diagnosis of any other bleeding/coagulation disorder other than hemophilia A
* Use of another hemostatic agent as the primary method of bleeding prophylaxis during the observation period
* Contra-indications according to the local marketing authorization
* Current immune tolerance induction (ITI) treatment for a FVIII inhibitor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
12 Years
Study:
NCT07088458
Study Brief:
Protocol Section:
NCT07088458