Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Clinical Trials in China / NCT06833983
Recruiting Phase 3

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

NCT06833983 · tracked via the Priya Life Science China tracker
Sponsor
Gritgen Therapeutics Co., Ltd
Phase
Phase 3
Started
2025-03-31
Last updated
2025-12-09

Condition(s) studied

Hemophilia A

Investigational drug(s) / intervention(s)

GS1191-0445 injection →

GS1191-0445 injection: A single intravenous administration of GS1191-0445 injection at a dose of 3E12 vg/kg

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

Sex
MALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Annualized Bleeding Rate (ABR) — Weeks 3 to 52 after infusion
    To evaluate the efficacy of a single intravenous administration of GS1191-0445 in subjects with hemophilia A

Trial sites (13)

FacilityCityRegionStatus
Anhui Provincial Hospital Hefei Anhui Not Yet Recruiting
Peking Union Medical College Hospital Beijing Beijing Municipality Not Yet Recruiting
First Hospital of Lanzhou University Lanzhou Gansu Not Yet Recruiting
Nanfang Hospital Southern Medical University Guangzhou Guangdong Not Yet Recruiting
North China University of Science and Technology Affiliated Hospital Tangshan Hebei Not Yet Recruiting
Henan Cancer Hospital Zhengzhou Henan Not Yet Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Not Yet Recruiting
Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu Not Yet Recruiting
Jiangxi Provincial People's Hospital Nanchang Jiangxi Not Yet Recruiting
Central Hospital Affiliated to Shandong First Medical University Jinan Shandong Recruiting
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin Tianjin Municipality Recruiting
The second Affiliated Hospital of Kunming Medical University Kunming Yunnan Not Yet Recruiting

More Gritgen Therapeutics Co., Ltd. trials in China

To Evaluate the Safety and Efficacy of GS1168 Injection in Adult Phenylketonuria Starting soon
To Evaluate the Safety and Efficacy of GS1191-0445 Injection in the Treatment of Severe Hemophilia A Active, not recruiting

Other trials for the same condition

Lentiviral FVIII Gene Therapy Starting soon
Safety and Efficacy Study of NGGT003 in Hemophilia A Patients Recruiting
Gene Therapy for Chinese Hemophilia A Recruiting
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors Recruiting
Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06833983 on ClinicalTrials.gov ↗ ← All trials in China