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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT05395858
Eligibility Criteria:
Inclusion Criteria:
* Male or female with a diagnosis of hemophilia A
* Previously or currently treated with damoctocog alfa pegol for at least 6 months.
* Treated with damoctocog alfa pegol per the US approved label to include:
* Aged ≥12 years at the time of damoctocog alfa pegol treatment initiation
* Previously treated for hemophilia A with an FVIII replacement therapy other than damoctocog alfa pegol
* Treatment modality of on-demand, prophylactic, intermittent prophylaxis or a combination thereof
* Have data in the medical record at the participating site as follows:
* For a minimum of 6 months prior to the damoctocog alfa pegol initiation date
* For a minimum of 6 months post-damoctocog alfa pegol initiation date AND the patient was receiving treatment with damoctocog alfa pegol during this 6-month follow-up period AND this data is dated prior to the central institutional review board (IRB) approval date for the study
* To include the FVIII replacement therapy most recently received prior to the initiation of damoctocog alfa pegol
* For patients in the prospective cohort
* Signed informed consent
* Current treatment with damoctocog alfa pegol or discontinued use of damoctocog alfa pegol within 3 months prior to the date of enrollment into the retrospective cohort.
Exclusion Criteria:
* Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.
* Participation in any past or current damoctocog alfa pegol interventional trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05395858
Study Brief:
Protocol Section:
NCT05395858