To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A

Recruiting now · Phase 3

Conditions studied: Hemophilia A

In brief

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.

Key facts

Study ID

NCT06833983

Run by

Gritgen Therapeutics Co., Ltd.

People needed

50

Starts

2025-03-31

Expected to finish

2030-11-30

Last updated by the study team

2025-12-09

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 chronic hepatitis C virus (HCV) infection; Or are receiving antiviral treatment for hepatitis B and C;
• Active systemic immune disease.

Where it is running

• Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College — Tianjin, Tianjin Municipality, China (enrolling)
• Central Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (enrolling)
• 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
• Anhui Provincial Hospital — Hefei, Anhui, China
• The second Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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