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 FVIII 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
Anhui Provincial Hospital
Hefei 1808722, Anhui 1818058 230001
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing 1816670, Beijing Municipality 2038349 100005
ChinaSite Not Available
First Hospital of Lanzhou University
Lanzhou, Gansu 730099
ChinaSite Not Available
First Hospital of Lanzhou University
Lanzhou 1804430, Gansu 1810676 730099
ChinaSite Not Available
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong 510515
ChinaSite Not Available
Nanfang Hospital Southern Medical University
Guangzhou 1809858, Guangdong 1809935 510515
ChinaSite Not Available
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei 063000
ChinaSite Not Available
North China University of Science and Technology Affiliated Hospital
Tangshan 1793346, Hebei 1808773 063000
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan 450003
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou 1784658, Henan 1808520 450003
ChinaSite Not Available
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei 430022
ChinaSite Not Available
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan 1791247, Hubei 1806949 430022
ChinaSite Not Available
Xiangya Hospital of Central South University
Changsha, Hunan 410028
ChinaSite Not Available
Xiangya Hospital of Central South University
Changsha 1815577, Hunan 1806691 410028
ChinaSite Not Available
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210000
ChinaSite Not Available
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing 1799962, Jiangsu 1806260 210000
ChinaSite Not Available
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi 344001
ChinaSite Not Available
Jiangxi Provincial People's Hospital
Nanchang 1800163, Jiangxi 1806222 344001
ChinaSite Not Available
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong 250013
ChinaSite Not Available
Central Hospital Affiliated to Shandong First Medical University
Jinan 1805753, Shandong 1796328 250013
ChinaActive - Recruiting
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin 300020
ChinaSite Not Available
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin 1792947, Tianjin Municipality 1792943 300020
ChinaActive - Recruiting
The second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan 650101
ChinaSite Not Available
The second Affiliated Hospital of Kunming Medical University
Kunming 1804651, Yunnan 1785694 650101
ChinaSite Not Available

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