NCT06833983RecruitingPhase 3
To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A
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
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 28 Jan 2025
- Start date
- 31 Mar 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Gritgen Therapeutics Co., Ltd.
- Diseases
- Haemophilia
- NCT number
- NCT06833983
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 50
- From 31 Mar 2025 to the primary completion date, 30 Nov 2026
- 13 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, 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.
Age in the registry: 18 years to 65 years · Sex: Male · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Central Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| The Second Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Not yet recruiting |
| First Hospital of Lanzhou University Coordinator of this site? Confirm its status | Lanzhou | China | Not yet recruiting |
| Jiangxi Provincial People's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Not yet recruiting |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| North China University of Science and Technology Affiliated Hospital Coordinator of this site? Confirm its status | Tangshan | China | Not yet recruiting |
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.