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 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT02634918
Eligibility Criteria:
Inclusion Criteria:
1. All children ages 6 months - 18 years with hemophilia A or B
2. Hemophilia subjects with and without a history of hemarthroses including target joints ( joint of interest) and joints without documented bleeds( control joints)
3. Hemophilia subjects with a history of inhibitor to FVIII or FIX and documented hemarthroses
4. History of hemarthroses more than 4 weeks prior to study enrolment to allow for resolution of hemarthroses which could affect detection of synovial and cartilage changes
Exclusion Criteria:
1. Bleeding disorder subjects without a diagnosis of hemophilia
2. Hemophilia subjects with any underlying illness such as liver or renal disease or any systemic illness such as diabetes or any other chronic illness apart from the hemophilia
3. Hemophilia subjects on medications which could increase bleeding risk such as non steroidal anti inflammatory agents, anti seizure medications apart from factor concentrates
4. History of hemarthroses within the 4 weeks prior to study enrolment
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
6 Months
Maximum Age:
18 Years
Study:
NCT02634918
Study Brief:
Protocol Section:
NCT02634918