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FRSW107 Prophylactic Therapy in Severe Hemophilia A
NCT07684898Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Jun 2026
- Primary completion
- Mar 2027
- Countries
- 1
- Sponsor
- Gensciences
- Conditions
- hemophilia A
01
Overview
Phase 3, open-label, single-arm trial of recombinant human coagulation factor viii-fc fusion protein in hemophilia A, sponsored by Gensciences. Primary endpoint: Annualized Bleeding Rate at 6 months. Started Jun 2026; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
prophylactic treatment
Subjects receive FRSW107 prophylactically. PK subgroup gets 50 IU/kg initially for PK profiling, then individualized 25-50 IU/kg Q3D. Non-PK subgroup gets 25-50 IU/kg Q3D.
03
Who it enrols
Males aged 12-65 with severe hemophilia A (FVIII < 1%) and >=150 exposure days to prior FVIII products, without FVIII inhibitors or recent use of emicizumab, fitusiran, or gene therapy.
04
Endpoints
Primary
Annualized Bleeding Rate
Secondary
Safety Evaluation
Immunogenicity Evaluation
Peak activity
Effective rate of hemostatic treatment
Annualized rate of spontaneous bleeds
Annualized rate of traumatic bleeds
Annualized Joint Bleed Rate
Number of target joints
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