Brief Title
BAY14-2222 Continuous Infusion in Surgeries
Official Title
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.
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A
Secondary Outcome
Evaluate the safety of rFVIII-FS.
Condition
Hemophilia
Intervention
Kogenate (BAY14-2222)
Study Arms / Comparison Groups
Arm 1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
15
Start Date
July 2004
Completion Date
May 2005
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
Gender
Male
Ages
12 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Israel
Location Countries
Israel
Administrative Informations
NCT ID
NCT00606060
Organization ID
11486
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
April 2010