RecruitingPhase 3NCT06081062

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


Sponsor

ISU Abxis Co., Ltd.

Enrollment

24 participants

Start Date

Apr 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 8 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Active comparator (Agalsidase beta) and a biological treatment called Fabagal® (Agalsidase beta) for people with fabry disease. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 8 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFabagal® (Agalsidase beta)

1 mg/kg every 2 weeks for 12 months

DRUGActive comparator (Agalsidase beta)

1 mg/kg every 2 weeks for 12 months


Locations(3)

Philippine General Hospital

Manila, Philippines

St.Luke's Medical Center

Manila, Philippines

Seoul Asan Center

Seoul, Songpa-gu, South Korea

View Full Details on ClinicalTrials.gov

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NCT06081062


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