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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT05022459
Eligibility Criteria:
Inclusion Criteria:
1. Participant (if 18 years of age or older) or parent/LAR is willing and able to provide written informed consent; minor participant is willing and able to provide assent, if applicable based on site and local regulations
2. Male participants with moderate to severe Hemophilia A ( FVIII activity \</= 5%) between 6 to 19 years of age without inhibitors are eligible for participation in this study
3. Participants must be on Emicizumab or standard FVIII prophylaxis per institutional/primary hematologist recommendations
4. Participants must be engaging in sports activities with moderate to high risk of bleeding as defined by the NHF- Playing it Safe guidelines (numerical rating \>/= 2).
5. Participants must be compliant with completing all standard of care bleed and treatment logs
6. Participant must be willing to keep daily activity logs for the duration of the study.
Exclusion Criteria:
1. Participant/parent/LAR unwilling to provide informed consent/assent
2. Unwilling to log or document bleeds and treatment information as per study guidelines
3. Participants with any other bleeding disorders will be excluded
4. Participants on concomittent FVIII replacement and emicizumab for sports participation
Sex:
MALE
Minimum Age:
6 Years
Maximum Age:
19 Years
Study:
NCT05022459
Study Brief:
Protocol Section:
NCT05022459