A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
← catalyst calendarNCT07285460 · readout in 1,081 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
85estimated
Sites
30
Countries
Belgium, Brazil, Canada +10
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-18 | actual | When the study began enrolling |
| Primary completion | 2029-08-04 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-12-30 | estimated | The whole study's end, after follow-up |
| First posted | 2025-12-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hemophilia
Interventions
- Drug: Fitusiran — also filed as SAR439774, Qfitlia™
- Biological: Clotting factor concentrates (CFC) or bypassing agents (BPA)
- Biological: Antithrombin concentrate (ATIIIC)
Primary outcome
what the primary-completion date above is the date OFAnnualized treated bleeding rate (ABR) in the fitusiran primary efficacy period and in the SOC period
measured Day 85 to Day 421 (fitusiran primary efficacy period); Day -168 to Day -1 (SOC period)
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