BAY14-2222 Continuous Infusion in Surgeries

Bayer

Status and phase

Completed

Phase 3

Conditions

Hemophilia

Treatments

Drug: Kogenate (BAY14-2222)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00606060

11486

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

Male

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

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