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

Plain-language summary

This study evaluates the injection GS1191-0445 in patients with hemophilia A. It enrolls male patients aged 18-65 with confirmed hemophilia A who have used FVIII products for at least 150 exposure days and have no history of FVIII inhibitors. The study is Phase 3 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Recruiting

Sponsor

Gritgen Therapeutics Co., Ltd.

Intervention

GS1191-0445 injection

Start date

3/31/2025

Estimated completion

11/30/2030

Countries

China

Related genes

Locations

• Hefei, China
• Beijing, China
• Lanzhou, China
• Guangzhou, China
• Tangshan, China
• Zhengzhou, China
• Wuhan, China
• Changsha, China
• Nanjing, China
• Nanchang, China
• Jinan, China
• Tianjin, China
• Kunming, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.