Humacyte ATEV Met Superiority Primary Endpoint Compared to Standard of Care AV Fistula in Interim Analysis of V012 Phase 3 Study in Female Dialysis Access Patients
Humacyte announced positive interim results from its V012 Phase 3 study of ATEV for dialysis access in female patients, meeting the primary endpoint with high statistical significance. Patients receiving ATEV achieved an average of 220 catheter-free days compared to 129 for the standard-of-care AV fistula, a difference of 91 days (p=0.0007). The ATEV also demonstrated a superior safety profile with an infection rate of 6 per 100 patient years versus 23 for AV fistula, and no study access-associated infections were reported in the ATEV group.
Key figures
- Drug Name
- ATEV
- Phase Of Trial
- Phase 3
- P value
- 0.0007
- Infection rate avf
- 23 per 100 patient years
- Infection rate atev
- 6 per 100 patient years
- Catheter free days avf
- 129
- Catheter free days atev
- 220
- Total patients enrolled
- 120
- Patients enrolled interim
- 80
- Catheter free days difference
- 91
AI analysis
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