BAY14-2222 Continuous Infusion in Surgeries
- Registration Number
- NCT00606060
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Kogenate (BAY14-2222) -
- Primary Outcome Measures
Name Time Method efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A 28 days
- Secondary Outcome Measures
Name Time Method Evaluate the safety of rFVIII-FS. 28 days