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

NCT06081062 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-07-29

No results posted yet for this study

Summary

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

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

Sponsors & Collaborators

  • ISU Abxis Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-14
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • Philippines
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06081062 on ClinicalTrials.gov