94
Participants
Start Date
June 9, 2011
Primary Completion Date
September 9, 2019
Study Completion Date
October 27, 2020
Recombinant Factor VIII (Kovaltry, BAY81-8973)
Main study: 25-50 IU/kg at least 2x/week for 6 months and at least 50 EDs, IV infusion; Extension study: 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part A and extension study), IV infusion. Exposure day (ED): An ED is a unit of time (1 day) in which replacement treatment of Hemophilia is given to a patient.
Recombinant Factor VIII (Kovaltry, BAY81-8973)
Main study: 15-50 IU/kg at least 1x/week for at least 50 EDs or until inhibitor development, IV infusion; Extension study: For participants having reached at least 50 EDs in main study - Part B: 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part B and extension study), IV infusion. For participants who developed an inhibitor in main study - Part B: up to 200 IU/kg per day or 100 IU/kg twice a day at the discretion of the investigator and coordinating investigator until successful eradication of the inhibitor, or until failure, for up to18 months (treatment beyond 18 months required an agreement with the sponsor and coordinating investigator), IV infusion
Crumlin
Budapest
Plovdiv
Debrecen
Mohács
Århus N
Esplugues de Llobregat
Varna
Cáceres
A Coruña
Milan
Madrid
Padua
Cleveland
Guadalajara
Cincinnati
Valencia
Oaxaca City
New Orleans
Bari
San Juan del Río
Catania
Kazan'
Timișoara
Volgograd
Cluj-Napoca
Kirov
Ramat Gan
Columbus
Bahía Blanca
Edmonton
Hamilton
Toronto
Rome
Riga
Vilnius
Oslo
Lodz
Warsaw
Wroclaw
Bucharest
Bucharest
Alicante
Lead Sponsor
Bayer
INDUSTRY