Tests a single gene therapy dose for hemophilia A in adults
Tests GS1191-0445, a one-time gene therapy, in adults with hemophilia A.
Plain-language title generated from the registry record
Registry title: To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A
Key facts
- Where
- Beijing, Changsha, Guangzhou, Hefei, Jinan, Kunming, Lanzhou, Nanchang, Nanjing, Tangshan, Tianjin, Wuhan, and Zhengzhou, ChinaSee the 13 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06833983, who can take part
Where in China
- Peking Union Medical College HospitalBeijing, ChinaNot yet recruiting
- Xiangya Hospital of Central South UniversityChangsha, ChinaNot yet recruiting
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaNot yet recruiting
- Anhui Provincial HospitalHefei, ChinaNot yet recruiting
- Central Hospital Affiliated to Shandong First Medical UniversityJinan, ChinaTaking people
- The Second Affiliated Hospital of Kunming Medical UniversityKunming, ChinaNot yet recruiting
- First Hospital of Lanzhou UniversityLanzhou, ChinaNot yet recruiting
- Jiangxi Provincial People's HospitalNanchang, ChinaNot yet recruiting
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing, ChinaNot yet recruiting
- North China University of Science and Technology Affiliated HospitalTangshan, ChinaNot yet recruiting
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeTianjin, ChinaTaking people
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaNot yet recruiting
- Henan Cancer HospitalZhengzhou, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gritgen Therapeutics Co., Ltd.
- Trial code
- NCT06833983
- Record updated
- 9 December 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Understand the purpose and risks of the study and provide informed consent in accordance 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 on clinical laboratory examination ; Subjects had used FVIII products for at least 150 exposure days (ED) before enrollment; Subject has no prior history of FVIII inhibitors; Subjects agree to use a reliable barrier contraceptive method from the date of signing the informed consent; Subject is willing and able to follow planned visits, treatment plans, and other study procedures.
Exclusion: The subject has acute or chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection; Or are receiving antiviral treatment for hepatitis B and C; The subject has any hemorrhagic disorder not related to hemophilia A,; Active systemic immune disease; Abnormal laboratory examination of subjects during screening; Abnormal liver function test results of subjects during screening.