Actively Recruiting
To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A
Led by Gritgen Therapeutics Co., Ltd. · Updated on 2025-12-09
50
Participants Needed
13
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study purpose and risks and provide informed consent
- Male aged over 18 and up to 65 years at consent
- Confirmed diagnosis of Hemophilia A by history and lab tests
- Used factor VIII products for at least 150 exposure days before enrollment
- No prior history of factor VIII inhibitors
- Agree to use reliable barrier contraception from consent date
- Willing and able to follow planned visits, treatment, and procedures
You will not qualify if you...
- Any bleeding disorder not related to Hemophilia A
- Abnormal liver function test results during screening
- Abnormal laboratory examination results during screening
- Acute or chronic hepatitis B or C infection, or receiving antiviral treatment for these
- Active systemic immune disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Not Yet Recruiting
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Not Yet Recruiting
3
First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730099
Not Yet Recruiting
4
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China, 510515
Not Yet Recruiting
5
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China, 063000
Not Yet Recruiting
6
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
7
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
8
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410028
Not Yet Recruiting
9
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
10
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China, 344001
Not Yet Recruiting
11
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250013
Actively Recruiting
12
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
13
The second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650101
Not Yet Recruiting
Research Team
Y
Yanfang Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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