Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06081062
PHASE3

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

Sponsor: ISU Abxis Co., Ltd.

View on ClinicalTrials.gov

Summary

Evaluate the safety and efficacy of Fabagal® developed by ISU ABXIS Co., Ltd., which has similar efficacy 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

Key Details

Gender

All

Age Range

8 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-04-14

Completion Date

2025-12

Last Updated

2024-07-29

Healthy Volunteers

No

Conditions

Interventions

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

Locations (3)

Philippine General Hospital

Manila, Philippines

St.Luke's Medical Center

Manila, Philippines

Seoul Asan Center

Seoul, Songpa-gu, South Korea