Clinical Trial

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

Recruiting Phase 3
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-02-13; most recent amendment 2025-12-05.
Status change: Not Yet Recruiting → Recruiting 2025-04-20
Trial Details
NCT Number NCT06833983
Lead Sponsor Gritgen Therapeutics Co., Ltd.
Conditions Hemophilia A
Enrollment 50 participants
Start Date 2025-03-31
Primary Completion 2026-11-30 (estimated)
Study Completion 2030-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-09