Trial Profile

An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT-EXT)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 02 May 2025

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At a glance

Drugs Odevixibat (Primary)
Indications Alagille syndrome; Biliary atresia
Focus Registrational; Therapeutic Use
Acronyms ASSERT-EXT
Sponsors Albireo AB

Most Recent Events

30 Jan 2025 Planned End Date changed from 16 Apr 2027 to 9 Apr 2026.
30 Jan 2025 Planned primary completion date changed from 9 Oct 2026 to 9 Apr 2026.
18 Nov 2024 According to Ipsen media release, Final data from an open-label, Phase 3 study of odevixibat in patients with Alagille syndrome will be presented at the American Association for the Study of Liver Diseases (AASLD) on Monday 18 November.

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