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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT00323856
Eligibility Criteria:
Inclusion Criteria:
* Male.
* At least 6 years of age and not more than 65 years of age.
* Signed and dated Informed Consent Form and Patient Authorization for Release of Information approved by the appropriate Institutional Review Board (IRB) prior to screening and enrollment. If the subject is a minor (i.e., less than 18 years of age) both he and his parent or legal guardian must sign and date the informed consent.
* Diagnosis of severe hemophilia A.
* Levels of Factor VIII less than 0.01 IU/mL.
* Treatment with cryoprecipitate, Factor VIII concentrates, and/or whole blood, for at least 150 cumulative exposure days (CEDs) prior to enrollment.
* No treatment with cryoprecipitate, Factor VIII concentrate, or any other blood product, for at least 72 hours prior to screening.
* No previous diagnosis with inhibitors to Factor VIII at any detectable titer.
* Subjects must never have been diagnosed with nonspecific inhibitors of coagulation.
* Negative test for the presence of Factor VIII inhibitors at screening and enrollment.
* CD4 counts greater than or equal to 400 cells/µL.
* Vaccination against hepatitis A and hepatitis B, or evidence of antibodies against hepatitis A and hepatitis B. (A subject who has no prior immunity against hepatitis A will be offered a course of vaccination for hepatitis A).
* Karnofsky Performance Score of at least 50.
Exclusion Criteria:
* Any immunosuppressive medications including intravenous immunoglobulins at the time of enrollment.
* Clinical signs or symptoms of an infection, such as fever, chills or nausea during screening or enrollment.
* History of frequent reactions to Factor VIII concentrates (e.g., chills or headaches).
* Prior treatment with Alphanate® (Solvent-Detergent/ Heat-Treated).
* Immunocompromised (including HIV+ status or has an impaired immune system due to disease or treatment).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
6 Years
Maximum Age:
65 Years
Study:
NCT00323856
Study Brief:
Protocol Section:
NCT00323856