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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT02582060
Eligibility Criteria:
Inclusion Criteria:
* Males, 5-70 years, inclusive
* Plasma FVIII activity \<1% documented (Laboratory result or MD documentation of Severe Hemophilia A diagnosis)
* Currently prescribed prophylaxis treatment regimen infusing ≥3 times a week
* Willing to alter their prophylaxis treatment regimen per study protocol
Exclusion Criteria:
* Bleeding disorder(s) other than Hemophilia A
* Current inhibitor (\>0.6BU)
* Thrombocytopenia (platelet count \<100,000K/µL since it can alter TEG®/ROTEM® results)
* Creatinine \>2x the upper limit of normal (indicating potential platelet dysfunction)
* Prothrombin time \>3 seconds above the upper limit of normal (indicating potential liver dysfunction)
* Any concurrent clinically significant major disease, frequent bleeding pattern or history of non-compliance that, in the opinion of the investigator, would make the subject unsuitable for enrollment
* Participation within the past 30 days in any other clinical study involving investigational drugs
* Planned major surgery within 30 days prior to screening or during the study period
* Current use of any medication known to have effects on the coagulation system
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
5 Years
Maximum Age:
70 Years
Study:
NCT02582060
Study Brief:
Protocol Section:
NCT02582060