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

RecruitingPhase 3Ages 18 Years - 65 YearsMaleGritgen Therapeutics Co., Ltd.
NCT06833983 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Understand the purpose and risks of the study and provide informed consent in accordance with national and local privacy laws: 2. Subject must be male, aged \>18 years old at the time of signing informed consent, and ≤65 years old: 3. Participants with confirmed hemophilia A in their pre-admission history and based on clinical laboratory examination ; 4. Subjects had used FVIII products for at least 150 exposure days (ED) before enrollment; 5. Subject has no prior history of FVIII inhibitors; 6. Subjects agree to use a reliable barrier contraceptive method from the date of signing the informed consent 7. Subject is willing and able to follow planned visits, treatment plans, and other study procedures. Exclusion Criteria: 1. The subject has any hemorrhagic disorder not related to hemophilia A, 2. Abnormal liver function test results of subjects during screening. 3. Abnormal laboratory examination of subjects during screening 4. 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; 5. Active systemic immune disease.
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What it tests

  • GS1191-0445 injection
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Where

13 sites
Anhui Provincial Hospital
Hefei, China
Peking Union Medical College Hospital
Beijing, China
First Hospital of Lanzhou University
Lanzhou, China
Nanfang Hospital Southern Medical University
Guangzhou, China
North China University of Science and Technology Affiliated Hospital
Tangshan, China
Henan Cancer Hospital
Zhengzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Xiangya Hospital of Central South University
Changsha, China

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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