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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT05643560
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis hemophilia A with FVIII:C ≤2%.
* Patients ≥ 18 years of age.
* Previously treated for hemophilia A (PTPs).
* Patients who had initiated damoctocog alfa pegol maximum 12 months prior to enrollment into the study or who initiate damoctocog alfa pegol treatment at the enrollment , where the decision to initiate damoctocog alfa pegol has been made before the decision for study participation.
* Patients having a HEAD-US measurement available in the 2 months prior to damoctocog alfa pegol treatment initiation.
* Patients without previous history of FVIII inhibitors or patients with previous history of FVIII inhibitors on standard prophylaxis therapy for at least 1 year prior to baseline (damoctocog alfa pegol treatment initiation).
* No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor.
* Signed informed consent/assent.
Exclusion Criteria:
* Concurrent participation in an investigational program with interventions outside of routine clinical practice.
* Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.
* Patient on immune tolerance induction (ITI) treatment at the time of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05643560
Study Brief:
Protocol Section:
NCT05643560