Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Dise
Evaluate the safety and efficacy of Fabagal® developed by ISU ABXIS Co., Ltd., which has similar efficacy to active comparator (Agalsidase beta).
| Condition(s) | Fabry Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Evaluate the safety and efficacy of Fabagal® developed by ISU ABXIS Co., Ltd., which has similar efficacy to active comparator (Agalsidase beta). |
| Who can participate | 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 screen |
| Ages | 8 Years |
| Sex | All |
| Lead sponsor | ISU Abxis Co., Ltd. |
| Locations | Manila, Philippines; Manila, Philippines; Seoul, Songpa-gu, South Korea |
| Start date | 2023-04-14 |
| NCT ID | NCT06081062 |
| Official listing | https://clinicaltrials.gov/study/NCT06081062 |