80
Participants
Start Date
January 31, 2011
Primary Completion Date
December 31, 2012
Study Completion Date
December 31, 2012
rFVIII (BAY81-8973) on demand
Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
rFVIII (BAY81-8973) prophylaxis low-dose
Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
rFVIII (BAY81-8973) prophylaxis high-dose
Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
Johannesburg
Bangkok
Jakarta
Bangkok
Belgrade
Taipei
Niš
Novi Sad
Kragujevac
Taichung
Guadalajara
Dayton
Houston
Olomouc
San Luis Potosí City
Lviv
Simferopol
Beijing
Saint Petersburg
Shanghai
Suzhou
Timișoara
Tianjin
Baia Mare
Hyderabad
Guangzhou
Yekaterinburg
Barnaul
Khabarovsk
Buenos Aires
Corrientes
Rosario
Bogotá
Bucaramanga
Kiev
Hiroshima
Nishinomiya
Kashihara
Shinjuku-ku
Suginami
Bucharest
Bucharest
Bratislava
Pretoria
Adana
Antalya
Izmir
Lead Sponsor
Bayer
INDUSTRY