Trial Profile

Multi-centre, Open-label Trial to Assess the saFety, Pharmacodynamics, Efficacy and Pharmacokinetics of pegunigaLsidase Alfa in Patients From 2 Years to Less Than 18 Years of Age With Confirmed FabrY Disease

Status: Recruiting

Phase of Trial: Phase II/III

Latest Information Update: 02 Apr 2026

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At a glance

Drugs Pegunigalsidase alfa (Primary)
Indications Fabry's disease
Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational; Therapeutic Use
Acronyms FLY
Sponsors Chiesi Farmaceutici SpA

19 Sep 2025 Planned primary completion date changed from 1 Dec 2027 to 1 Oct 2028.
18 Dec 2024 Planned initiation date (estimated date of first participant enrollment) changed from 1 Oct 2024 to 1 Feb 2025.
18 Dec 2024 Status changed from not yet recruiting to recruiting.

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