clinical trial · NCT06081062
Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease
ISU Abxis Co., Ltd.·phase3·recruiting·n = 24
Fabry DiseaseFabagal® (Agalsidase beta)Active comparator (Agalsidase beta)
brief summary
Evaluate the safety and efficacy of Fabagal® developed by ISU ABXIS Co., Ltd., which has similar efficacy to active comparator (Agalsidase beta).
started
Apr 14, 2023
primary completion
Jun 1, 2025
completion
Dec 1, 2025
last updated
Jul 29, 2024
detailed description
The primary objective is to evaluate the efficacy of Fabagal compared to active comparator (Agalsidase beta). The secondary objectives will evaluate the safety, pharmacokinetics, and immunogenicity of Fabagal compared to active comparator (Agalsidase beta).
official title
A Phase 3 Randomized, Double-blinded, Active-controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol