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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT01184820
Eligibility Criteria:
Inclusion Criteria:
* Male subjects with severe hemophilia A (documented plasma baseline Factor VIII level \<1 %)
* \>/= 18 but \</= 65 years of age
* Previously treated with Factor VIII concentrate(s) for a minimum of 150 exposure days (as supported by the subject's medical history)
* Immunocompetent with a CD4+ lymphocyte count \> 400/mm³
* Signed informed consent from subject
Exclusion Criteria:
* Documented history of inhibitor to Factor VIII with a titer \>/= 0.6 BU (Biological Unit), by the Nijmegen modified assay. However, subjects with a maximum historical titer of \</= 1.0 BU with the classical Bethesda assay on a single measurement but with at least 3 subsequent successive negative results (\< 0.6 BU) thereafter are eligible.
* Unable to stop Factor VIII treatment to complete a minimum 72 hour washout
* Current evidence of inhibitor to Factor VIII with a titer \>/= 0.6 BU, measured at the time of screening
* Abnormal renal function (serum creatinine \> 1.5 times the upper limit of the normal range)
* Total bilirubin \> 1.5 times the upper limit of the normal range
* Active hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels \> 2 times the upper limit of the normal range)
* Any concomitant coagulation disorder other than hemophilia A (including lupus anticoagulant)
* Platelet count \< 100,000/mm³
* Within the last 3 months prior to study entry or during the study will be treated with an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a interferon, steroids, rituximab, etc)
* Any subject who requires major surgery during study period. Minor procedures may be approved if discussed in advance with the medical expert.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01184820
Study Brief:
Protocol Section:
NCT01184820