At a glance
ClinicalIndex Comparison Record- ✓Male aged >18 and ≤65 years old
- ✓Confirmed hemophilia A diagnosis
- ✓At least 150 exposure days to FVIII products
- ✓No prior history of FVIII inhibitors
- ✕Any hemorrhagic disorder not related to hemophilia A
- ✕Abnormal liver function tests
- ✕Abnormal laboratory examination
- ✕Acute or chronic hepatitis B or C infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating GS1191-0445 injection for Hemophilia A. Currently recruiting, targeting 50 participants across 13 sites.
Detailed 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.
Study Details
Timeline
Interventions
A single intravenous administration of GS1191-0445 injection at a dose of 3E12 vg/kg