Trial Profile

ATLAS-PEDS: An Open-label, Multinational Study of Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 01 Apr 2025

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At a glance

Drugs Fitusiran (Primary)
Indications Haemophilia A; Haemophilia B
Focus Therapeutic Use
Acronyms ATLAS-PEDS
Sponsors Sanofi; Sanofi Genzyme

Most Recent Events

28 Mar 2025 According to Sanofi Media Release, the US FDA approved Qfitlia (fitusiran), as the first therapy in the US to treat hemophilia A or B with or without inhibitors based on the data from this trail along with other ATLAS trials.
01 Feb 2024 phase 2\3 changed to phase 3.
01 Feb 2024 Planned End Date changed from 27 Dec 2024 to 1 Aug 2028.

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