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

Last updated: April 20, 2025
Sponsor: Gritgen Therapeutics Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Hemophilia

Treatment

GS1191-0445 injection

Clinical Study ID

NCT06833983
GS1191-0445-GTHA-CN02
  • Ages 18-65
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Understand the purpose and risks of the study and provide informed consent inaccordance 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 onclinical laboratory examination ;

  4. Subjects had used FVII products for at least 150 exposure days (ED) beforeenrollment;

  5. Subject has no prior history of FVIII inhibitors;

  6. Subjects agree to use a reliable barrier contraceptive method from the date ofsigning the informed consent

  7. Subject is willing and able to follow planned visits, treatment plans, and otherstudy procedures.

Exclusion

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 chronichepatitis C virus (HCV) infection; Or are receiving antiviral treatment forhepatitis B and C;

  5. Active systemic immune disease.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: GS1191-0445 injection
Phase: 3
Study Start date:
March 31, 2025
Estimated Completion Date:
November 30, 2030

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230001
    China

    Site Not Available

  • First Hospital of Lanzhou University

    Lanzhou, Gansu 730099
    China

    Site Not Available

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • North China University of Science and Technology Affiliated Hospital

    Tangshan, Hebei 063000
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410028
    China

    Site Not Available

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi 344001
    China

    Site Not Available

  • Central Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong 250013
    China

    Active - Recruiting

  • Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

  • The second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650101
    China

    Site Not Available

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