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

Launched by GRITGEN THERAPEUTICS CO., LTD. · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called GS1191-0445 injection for men with hemophilia A, a genetic condition that affects blood clotting. The study will look at how effective and safe this treatment is when given as a single dose. GS1191-0445 works by delivering a gene that helps the body produce a necessary protein for blood clotting, which can help prevent bleeding episodes in patients. This trial will take place in multiple locations and is currently not recruiting participants.

To be eligible for this study, participants must be male, between 18 and 65 years old, and have a confirmed diagnosis of hemophilia A. They should have used factor VII products for at least 150 days before joining the study and must not have any history of developing inhibitors (which can make treatment less effective). Participants will need to agree to use reliable birth control and follow the study’s schedule for visits and treatments. It’s important for potential participants to understand the study’s purpose and potential risks before agreeing to take part.

Gender

MALE

Eligibility criteria

• 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 FVII 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.