Phase
Condition
Hemophilia
Treatment
GS1191-0445 injection
Clinical Study ID
Ages 18-65 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Understand the purpose and risks of the study and provide informed consent inaccordance with national and local privacy laws:
Subject must be male, aged >18 years old at the time of signing informed consent,and ≤65 years old:
Participants with confirmed hemophilia A in their pre-admission history and based onclinical laboratory examination ;
Subjects had used FVII products for at least 150 exposure days (ED) beforeenrollment;
Subject has no prior history of FVIII inhibitors;
Subjects agree to use a reliable barrier contraceptive method from the date ofsigning the informed consent
Subject is willing and able to follow planned visits, treatment plans, and otherstudy procedures.
Exclusion
Exclusion Criteria:
The subject has any hemorrhagic disorder not related to hemophilia A,
Abnormal liver function test results of subjects during screening.
Abnormal laboratory examination of subjects during screening
The subject has acute or chronic hepatitis B virus (HBV) infection or chronichepatitis C virus (HCV) infection; Or are receiving antiviral treatment forhepatitis B and C;
Active systemic immune disease.
Study Design
Connect with a study center
Anhui Provincial Hospital
Hefei, Anhui 230001
ChinaSite Not Available
First Hospital of Lanzhou University
Lanzhou, Gansu 730099
ChinaSite Not Available
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong 510515
ChinaSite Not Available
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei 063000
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan 450003
ChinaSite Not Available
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei 430022
ChinaSite Not Available
Xiangya Hospital of Central South University
Changsha, Hunan 410028
ChinaSite Not Available
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210000
ChinaSite Not Available
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi 344001
ChinaSite Not Available
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong 250013
ChinaActive - Recruiting
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin 300020
ChinaActive - Recruiting
The second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan 650101
ChinaSite Not Available
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