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Fitusiran

DRUG7 trials

Sponsors

Genzyme, a Sanofi Company, Sanofi

Conditions

HemophiliaHemophilia AHemophilia B

Phase 3

A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors
CompletedNCT03417102
Genzyme, a Sanofi CompanyHemophilia A, Hemophilia B
Start: 2018-02-14End: 2021-06-23Updated: 2022-03-28
A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors
CompletedNCT03417245
Genzyme, a Sanofi CompanyHemophilia A, Hemophilia B
Start: 2018-03-01End: 2021-07-14Updated: 2022-03-28
A Study of Fitusiran in Severe Hemophilia A and B Patients Previously Receiving Factor or Bypassing Agent Prophylaxis
CompletedNCT03549871
Genzyme, a Sanofi CompanyHemophilia
Start: 2018-07-25End: 2022-03-25Updated: 2023-02-06
Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX
Active, not recruitingNCT03754790
Genzyme, a Sanofi CompanyHemophilia
Start: 2019-01-09End: 2026-11-05Updated: 2025-12-17
Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B
CompletedNCT03974113
Genzyme, a Sanofi CompanyHemophilia
Start: 2020-01-28End: 2026-08-04Updated: 2026-09-08
A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
Active, not recruitingNCT05662319
SanofiHemophilia
Start: 2023-02-01End: 2029-01-25Updated: 2026-02-04
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
RecruitingNCT07285460
SanofiHemophilia
Start: 2025-12-18End: 2031-12-30Target: 85Updated: 2026-08-17

Related Papers

New fitusiran 10 mg dose increases proportion of people with hemophilia within target antithrombin range of 15–35%
Blood2025-11-03
Experience with minor surgeries in people with hemophilia A or B with and without inhibitors receiving fitusiran
Blood2025-11-03
High treatment compliance and tolerability with fitusiran antithrombin-based dose regimen in people with hemophilia A or B, with or without inhibitors: ATLAS-OLE study
Blood2025-11-03
Safety and efficacy of a fitusiran antithrombin-based dose regimen in people with hemophilia A or B: the ATLAS-OLE study
Blood2025-03-0720 citations
Mechanistic Modeling to Support Hemostatic Equivalency of Antithrombin Lowering in People with Hemophilia A or B
Blood2024-11-05
Reduced Doses of Factor Concentrates and Bypassing Agents to Treat Breakthrough Bleeds in Patients with Hemophilia A and B on Fitusiran Antithrombin-Based Dosing Regimen: ATLAS-OLE
Blood2024-11-05
Strategies for Increasing Racial and Ethnic Diversity in Hemophilia Clinical Trials and Their Outcomes
Blood2024-11-05
Fitusiran prophylaxis in people with hemophilia A or B who switched from prior BPA/CFC prophylaxis: the ATLAS-PPX trial
Blood2024-03-0733 citations
Fitusiran Population Pharmacokinetic and Pharmacodynamic Modeling Utilizing Phase 3 Clinical Trial Data to Confirm Doses Tested in Phase 3 Trials to Support an Antithrombin-Based Dose Regimen
Blood2023-11-02
S303: A PHASE 3 STUDY (ATLAS-PPX) TO EVALUATE EFFICACY AND SAFETY OF FITUSIRAN IN PEOPLE WITH HAEMOPHILIA A OR B WHO HAVE SWITCHED FROM PRIOR CLOTTING FACTOR CONCENTRATE OR BYPASSING AGENT PROPHYLAXIS
HemaSphere2023-08-012 citations
S301: CONSUMPTION OF FACTOR CONCENTRATES AND BYPASSING AGENTS FOR MANAGEMENT OF BREAKTHROUGH BLEEDS WITH FITUSIRAN PROPHYLAXIS IN PEOPLE WITH HAEMOPHILIA A OR B: ANALYSIS OF ATLAS-PPX
HemaSphere2023-08-01
Efficacy and safety of fitusiran prophylaxis in people with haemophilia A or haemophilia B with inhibitors (ATLAS-INH): a multicentre, open-label, randomised phase 3 trial.
2023-03-2977 citations
Fitusiran prophylaxis in people with severe haemophilia A or haemophilia B without inhibitors (ATLAS-A/B): a multicentre, open-label, randomised, phase 3 trial.
2023-03-2960 citations
Fitusiran Prophylaxis Improves Health-Related Quality of Life in People with Hemophilia a or B, with or without Inhibitors: Results of ATLAS-PPX Study
Blood2022-11-153 citations
Fitusiran, an Investigational siRNA Therapeutic Targeting Antithrombin for the Treatment of Hemophilia: First Results from a Phase 3 Study to Evaluate Efficacy and Safety in People with Hemophilia a or B <i>without</i> Inhibitors (ATLAS-A/B)
Blood2021-12-0215 citations
Efficacy and Safety of Fitusiran Prophylaxis, an siRNA Therapeutic, in a Multicenter Phase 3 Study (ATLAS-INH) in People with Hemophilia A or B, with Inhibitors (PwHI)
Blood2021-11-0515 citations
Sustained Improvement in Health-Related Quality of Life in Patients with Hemophilia A with or without Inhibitors Treated with Fitusiran Prophylaxis
Blood2021-11-051 citations