32
Participants
Start Date
June 30, 2007
Primary Completion Date
September 30, 2009
Study Completion Date
September 30, 2009
rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week
rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg)
rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection twice per week (30 IU/kg \[day 1\] + 40 IU/kg \[day 4\]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)
rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 75 IU/kg, dosing by injection three times per week (3 x 25 IU/kg \[day 1, 3, 5\]) for 9 months. No escalation opportunity for patients in this group
Moscow
Saint Petersburg
Yekaterinburg
Kirov
Lead Sponsor
Bayer
INDUSTRY