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A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab

StatusRecruiting
PhasePhase 4
SponsorSanofi
Started2024-03-01
View on ClinicalTrials.gov ↗
This is an exploratory, single group, Phase 4, study to assess treatment with fitusiran prophylaxis after switching from emicizumab prophylaxis. This study aims to evaluate the safety and tolerability of switching to fitusiran after a transition period from the last dose of emicizumab. The study will be conducted in male participants with severe hemophilia A, with or without inhibitors, aged ≥12 years, who were previously receiving emicizumab prophylaxis. Study details include: * The study duration will be up to approximately 28 months: * There will be an approximately 2-month screening period. * There will be an approximately 2-month period before fitusiran treatment starts (pre-fitusiran treatment period) * The fitusiran treatment duration will be up to 18-months (fitusiran treatment period) * The antithrombin (AT) follow-up (FU) period will be approximately 6 months after the last dose of fitusiran (during which the AT activity level will be monitored at approximately monthly intervals following the final fitusiran dose until AT activity levels return to at least 60%). * The study site visits are scheduled at monthly/ every 2 months intervals of 28 days (4 weeks) / 56 days (8 weeks), respectively, during the fitusiran treatment period.

Amendment record

Amended 4 times since 2023-11-17; most recent filed 2026-06-01. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-06-01
Amendment Study Status, Contacts/Locations v4
2025-09-24
Amendment Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
2024-03-06
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v2
2024-01-04
Amendment Study Status, Eligibility v1
2023-11-17
Original filing
Trial Details
NCT Number NCT06145373
Lead Sponsor Sanofi
Conditions Hemophilia A
Enrollment 20 participants
Start Date 2024-03-01
Primary Completion 2028-05-28 (estimated)
Study Completion 2030-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-02