A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia

About the trial

Sponsor

Sanofi

Tested

Fitusiran (drug), Clotting factor concentrates (CFC) or bypassing agents (BPA) (drug), Antithrombin concentrate (ATIIIC) (drug)

Dates

Started 2023-02-01; completion 2029-01-25

Results posted

Not yet

This is a multicenter, multinational, open-label, one-way cross-over, Phase 3, single-arm study for treatment of hemophilia. The purpose of this study is to measure the frequency of treated bleeding episodes with fitusiran in male adult and adolescent (≥12 years old) participants with hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX who have switched from their prior standard of care treatment. The total study duration will be up to approximately 50 months (200 weeks, 1 study month is equivalent to 4 weeks) and will include: * A screening period up to approximately 60 days, * A standard of care (SOC) period of approximately 6 study months (24 weeks), * A fitus…

From ClinicalTrials.gov, last updated 2026-02-04. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Genzyme Corporation reported $236,111 in research payments for this study in 2025 (75 payments).

Products named: Qfitlia

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.