NCT07548411Active, not recruitingPhase 1/2
To Evaluate the Safety and Efficacy of GS1191-0445 Injection in the Treatment of Severe Hemophilia A
A Single-arm, Open-label Study Evaluating the Safety and Efficacy of a Single Dose of GS1191-0445 Injection in Chinese Subjects With Severe Hemophilia A
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
This study is a single-arm, open-label study evaluating the safety and efficacy of GS1191-0445 injection as a single dose in Chinese subjects with severe hemophilia A. GS1191-0445 is an adeno-associated virus 8 (AAV8)-delivered gene therapy 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 gene expression cassette, which transfects hepatocytes and facilitates the specific expression and secretion of FVIII into the blood.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 26 Jan 2026
- Start date
- 10 Jul 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Gritgen Therapeutics Co., Ltd.
- Diseases
- Haemophilia
- NCT number
- NCT07548411
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 7
- From 10 Jul 2023 to the primary completion date, 31 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- The subject has any hemorrhagic disorder not related to hemophilia A,
- Active systemic immune disease.
Lab values
- Abnormal laboratory examination of subjects during screening
Other
- Abnormal liver function test results of subjects during screening.
Who the study is looking for
- 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:
- Participants with confirmed severe 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 received continuous prophylactic treatment with exogenous FVIII for one year prior to enrollment or has been treated with exogenous FVIII on demand;
- Subject has no history of hypersensitivity or allergic reactions related to the administration of FVIII agents;
- Subject has no 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.
Age in the registry: 18 years to 65 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.