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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT00357656
Eligibility Criteria:
Inclusion Criteria:
* The subject or the subject's legally authorized representative has provided signed informed consent.
* The subject is within 18 to 70 years of age.
* The subject has severe or moderately severe hemophilia A, defined by a baseline factor VIII level \<= 2% of normal, as tested at screening. A subset of 15 subjects per group must have baseline factor VIII levels \< 1% of normal.
* The aPTT must be within the range of normal after administration of FVIII concentrate, as determined in the preoperative pharmacokinetic evaluation, or as documented in the medical history, if available.
* The subject is scheduled to undergo an elective unilateral major orthopedic surgery that requires drain placement.
* The subject was previously treated with factor VIII concentrate(s) for a minimum of at least 150 exposure days (as estimated by the investigator) prior to study entry.
* Human immunodeficiency virus (HIV) positive subjects must be immunocompetent as determined with a CD4 count \>= 200 cells/mm³ (CD4 count at screening), but HIV negative subjects with a CD4 count \< 200 cells/mm³ qualify, if immunocompetency is documented.
* The subject has a life expectancy of at least 28 days from the day of surgery.
Exclusion Criteria:
* The subject has a detectable factor VIII inhibitor at screening, with a titer \>= 0.4 BU (Nijmegen modification of the Bethesda assay) in the central laboratory.
* The subject has a history of factor VIII inhibitors with a titer \>= 0.4 BU (by Nijmegen assay) or \>= 0.5 BU (by Bethesda assay) at any time prior to screening.
* The subject is scheduled to undergo any other concurrent minor or major surgery during the course of the study. The placement of central venous lines and the performance of fine needle aspiration biopsies are permitted.
* Excluding hemophilia-related physical impairments, the subject is assigned to NYHA class \>= III according to the New York Heart Association (NYHA).
* The subject has an abnormal renal function (serum creatinine \> 1.5 mg/dL).
* The subject has active hepatic disease (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] levels \> 5 times the upper limit of normal).
* The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) \> 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
* The subject has clinical and/or laboratory evidence of abnormal hemostasis from causes other than hemophilia A (e.g., late-stage chronic liver disease, immune thrombocytopenia purpura).
* The subject is currently receiving, or is scheduled to receive during the course of the study, an immunomodulating drug other than anti-retroviral chemotherapy (e.g., alpha-interferon, corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day).
* The subject has a known hypersensitivity to mouse or hamster proteins.
* The subject has received another investigational drug study within 30 days prior to screening and/or is scheduled to receive additional investigational drug during the course of the trial in the context of another investigational study.
* The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00357656
Study Brief:
Protocol Section:
NCT00357656