45
Participants
Start Date
September 22, 2020
Primary Completion Date
March 15, 2024
Study Completion Date
March 15, 2024
Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 1
"25 to 50 IU of Kovaltry per kg body weight given via intravenous (IV) infusion twice weekly, three times weekly, or every other day according to individual requirements for 6 months.~The dose decisions are at the discretion of the investigator."
Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 2
"12 year-old: 25 to 50 IU of Kovaltry per kg body weight given via intravenous (IV) infusion twice weekly, three times weekly, or every other day for 6 months.~\>12 year-old: 20 to 40 IU of Kovaltry per kg of body weight given via intravenous (IV) infusion two or three times per week for 6 months.~The dose decisions are at the discretion of the investigator."
Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 3
"15 to 50 IU of Kovaltry per kg body weight (minimum dose: 250 IU) given via intravenous (IV) infusions at least once a week.~The dose decisions are at the discretion of the investigator."
Children's Hospital of Shanxi, Taiyuan
Shijiazhuang General Hospital, Shijiazhuang
Beijing Children's Hospital, Capital Medical University, Beijing
Peking Union Medical College Hospital CAMS, Beijing
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School, Nanjing
1st Affiliated hospital of Soochow University, Suzhou
The Children's Hospital Zhejiang University School of Med, Hangzhou
Jiangxi Provincial People's Hospital, Nanchang
Chengdu Women & Children's Central Hospital, Chengdu
Childrens Hospital of Shanghai, Shanghai
Lead Sponsor
Bayer
INDUSTRY