Evaluating GS1191-0445 Injection for Hemophilia A Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a single-arm, open-label, multicenter evaluation of GS1191-0445 injection, a gene therapy designed to treat hemophilia A in male subjects aged 18 to 65. The study aims to assess the efficacy and safety of a single intravenous dose of GS1191-0445, which utilizes an AAV8-based vector to express human factor VIII in the liver. Participants will be monitored for their response to the treatment and any potential side effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Central Hospital Affiliated to Shandong First Medical University
  Jinan, Shandong, China Recruiting
• Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
  Tianjin, Tianjin Municipality, China Recruiting
• Anhui Provincial Hospital
  Hefei, Anhui, China Not yet recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• First Hospital of Lanzhou University
  Lanzhou, Gansu, China Not yet recruiting
• Nanfang Hospital Southern Medical University
  Guangzhou, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: Yanfang Li
• Email: yanfang.li@gritgen.com
• Phone: +8613817454595

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• NXT007 versus emicizumab to prevent bleeds in people with Hemophilia A

  This will test whether NXT007 prevents bleeding better than emicizumab in people aged 12 and older with Hemophilia A, including those with or without factor VIII inhibitors.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.