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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00606060
Eligibility Criteria:
Inclusion Criteria:
* Severe hemophilia A (FVIII:C \</=1%)
* No history of FVIII inhibitor formation and no current evidence of inhibitor antibody (Bethesda Assay \< 0.6 BU)
* Elective major surgery requiring at least 6 days of rFVIII-FS therapy
* Subjects should have been previously treated with FVIII concentrates for at least 150 exposure days. Previous treatment could have been with any type of rFVIII or with plasma-derived FVIII concentrate or cryoprecipitate
Exclusion Criteria:
* Abnormal renal function (serum creatinine \>1.3 mg/dL)
* Any treatments, which may change the clearance of FVIII (dialysis, plasma exchange)
* Anemia (hemoglobin \<11 g/dL)
* Known AIDS (HIV seropositive patients may be enrolled)
* Active liver disease (transaminases \> 5 times the upper limit of normal)
* History of severe reaction to FVIII concentrates
* Interferon treatment within the last 3 months
* Thrombocytopenia (\< 100,000 platelets/mm3) or other known hematological/bleeding problems other than hemophilia A
* Intake of other investigational drugs within 1 month prior to study entry
* Need for pre-medication for FVIII infusions (e.g. antihistamines)
* Diastolic blood pressure \>100 mm/Hg, which could not be controlled with antihypertensive medications
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT00606060
Study Brief:
Protocol Section:
NCT00606060