A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
← catalyst calendarNCT05662319 · readout in 218 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
91actual
Sites
50
Countries
Canada, China, France +14
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 | 2023-02-01 | actual | When the study began enrolling |
| Primary completion | 2027-03-25 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-01-25 | estimated | The whole study's end, after follow-up |
| First posted | 2022-12-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-04 | 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
- Drug: Clotting factor concentrates (CFC) or bypassing agents (BPA)
- Drug: Antithrombin concentrate (ATIIIC)
Primary outcome
what the primary-completion date above is the date OFAnnualized bleeding rate (ABR) in the fitusiran primary efficacy period
measured Day 169 to Day 505 (since the first dose of fitusiran)
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