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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Evaluate the safety of rFVIII-FS. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2004|
|Study Completion Date:||May 2005|
|Experimental: Arm 1||
Drug: Kogenate (BAY14-2222)
100 IU/mL (250 IU/vial nominal potency) continuous infusion over 6-11 days in 12 patients. 400 IU/mL (1000 IU/vial nominal potency) continuous infusion over 6-11days in 3 patients.