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To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A
Sponsor: Gritgen Therapeutics Co., Ltd.
Summary
This study is a single-arm, open-label, multicenter study evaluating the efficacy and safety of GS1191-0445 injection as a single dose in Chinese subjects with hemophilia A. GS1191-0445 is an AAV8-based gene therapy vector designed to express B-domain deleted human factor VIII (FVIII) under the regulation of a human liver-specific promoter. Following a single intravenous administration, AAV8 targets hepatocytes and facilitates the specific expression and secretion of FVIII into the bloodstream.
Official title: A Single-arm, Open-label, Multicenter Study Evaluating the Efficacy and Safety of GS1191-0445 Injection as a Single Dose in Chinese Subjects With Hemophilia A
Key Details
Gender
MALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-03-31
Completion Date
2030-11-30
Last Updated
2025-12-09
Healthy Volunteers
No
Conditions
Interventions
GS1191-0445 injection
A single intravenous administration of GS1191-0445 injection at a dose of 3E12 vg/kg
Locations (13)
Anhui Provincial Hospital
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
First Hospital of Lanzhou University
Lanzhou, Gansu, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China
The second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China