NCT06081062

Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: ISU Abxis Co., Ltd. · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and efficacy of Fabagal® developed by ISU ABXIS Co., Ltd., which has similar efficacy to active comparator (Agalsidase beta).

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).

Conditions

• Fabry Disease

Interventions

Type	Name	Description
BIOLOGICAL	Fabagal® (Agalsidase beta)	1 mg/kg every 2 weeks for 12 months
DRUG	Active comparator (Agalsidase beta)	1 mg/kg every 2 weeks for 12 months

Timeline

• Start date: 2023-04-14
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2023-10-12
• Last updated: 2024-07-29

Locations

3 sites across 2 countries: Philippines, South Korea