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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT00914459
Eligibility Criteria:
Inclusion Criteria:
* Male subjects less than 12 years of age with a documented history of severe hemophilia A (FVIII:C less than 1%).
* Subjects who are less than 6 years of age must have had at least 50 Exposure Days (EDs) to prior FVIII products (including blood products).
* Subjects who are equal to or greater than 6 years of age must have had greater than 150 EDs to prior FVIII products (including blood products).
Exclusion Criteria:
* For laboratory assessments, any measured Bethesda inhibitor titer equal to or greater than 0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor titer greater than ULN for the testing laboratory at the time of screening.
* Any other bleeding disorder in addition to hemophilia A.
* Treatment with any investigational drug or device within 30 days before the time of signing the parental informed consent/assent form.
* Major surgery planned to occur during the course of the study.
* Regular (e.g., daily; every other day) use of agents or medications known to influence platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs (NSAIDS).
* Regular, concomitant therapy with immunomodulating drugs (e.g., intravenous immunoglobulin \[IVIG\], routine systemic corticosteroids), or currently receiving immune tolerance induction (ITI) for inhibitor treatment.
* The subject is receiving treatment for HIV or hepatitis infection (unless the subject is on a stable antiviral regimen \[i.e., consistent treatment regimen for at least 3 months before the parental informed consent/assent form is signed\]).
* Platelet count less than 100,000/µL.
* Prothrombin time (PT) equal to or greater than 1.25 x ULN, or international normalized ratio (INR) equal to or greater than 1.5.
* Known hypersensitivity to hamster protein.
Healthy Volunteers:
False
Sex:
MALE
Maximum Age:
11 Years
Study:
NCT00914459
Study Brief:
Protocol Section:
NCT00914459