NCT06833983 To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A
| NCT ID | NCT06833983 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Gritgen Therapeutics Co., Ltd. |
| Condition | Hemophilia A |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 50 participants in total. It began in 2025-03-31 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06833983 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 65 Years, studying Hemophilia A. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06833983 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 50 participants.
Is NCT06833983 currently recruiting?
Yes, NCT06833983 is actively recruiting participants. Contact the research team at yanfang.li@gritgen.com for enrollment information.
Where is the NCT06833983 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Lanzhou, China, Guangzhou, China and 9 additional locations.
Who is sponsoring the NCT06833983 clinical trial?
NCT06833983 is sponsored by Gritgen Therapeutics Co., Ltd.. The trial plans to enroll 50 participants.