Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease
Trial Parameters
Brief Summary
Evaluate the safety and efficacy of Fabagal® developed by ISU ABXIS Co., Ltd., which has similar efficacy to active comparator (Agalsidase beta).
Eligibility Criteria
Inclusion Criteria: 1. Those who have been diagnosed with Fabry disease by genetic and alpha-galactosidase A enzyme tests and grouped by sex are as follows: * Male: Those who have confirmed GLA mutation (variation of α-galactosidase A gene) by genetic testing, and whose activity of alpha-galactosidase A in leukocytes is 5% or less than the normal mean value * Female: Those who have confirmed GLA mutation by genetic testing, and whose alpha-galactosidase A is within the normal range or is deficient 2. Age: Those who are aged 8 years or older 3. Those who have at least one of the following symptoms and signs: * Glomerular filtration rate decreased (Inclusion criteria: 2 or more cases of 30 ≦ eGFR \< 90 mL/min/1.73 m2 \[adjusted for age \>40\] \[including results within 6 months of the screening visit, but including results within 12 months for patients with a 60 ≦ eGFR \< 90 mL/min/1.73 m2\]) * Proteinuria that is equivalent to microalbuminuria or worse (Inclusion criteria: 2 or more cas