BAY14-2222 Continuous Infusion in Surgeries
Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in the treatment of patients with hemophilia A undergoing major elective surgery by achieving the required therapeutic concentrations.
- 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
- Abnormal renal function (serum creatinine >1.3 mg/dL) - Any treatments, which may change the clearance of FVIII (dialysis, plasmaexchange) - 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
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
E-mail: [email protected]
Phone: Not Available
Safety and efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (BAY 14 2222) concentrate in patients with hemophilia A undergoing major elective surgery.
Single Group Assignment