Actively Recruiting
Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease
Led by ISU Abxis Co., Ltd. · Updated on 2024-07-29
24
Participants Needed
3
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the safety and efficacy of Fabagal® developed by ISU ABXIS Co., Ltd., which has similar efficacy to active comparator (Agalsidase beta).
CONDITIONS
Official Title
Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Fabry disease confirmed by genetic testing and alpha-galactosidase A enzyme tests
- Males with confirmed GLA mutation and alpha-galactosidase A activity 5% or less of normal
- Females with confirmed GLA mutation and normal or deficient alpha-galactosidase A
- Aged 8 years or older
- Have at least one symptom such as decreased glomerular filtration rate, proteinuria, abnormal left ventricular function, clinically significant arrhythmias, or history of stroke or transient ischemic attack
- No prior enzyme replacement therapy or Chaperone therapy for Fabry disease
- Voluntarily consented and signed informed consent
- Agree to use medically appropriate contraception during the study if of childbearing potential
You will not qualify if you...
- Participated in another investigational study within 30 days before screening
- Have chronic kidney disease stage 4 or 5
- Currently on dialysis, have had a kidney transplant, or are scheduled for dialysis or transplant
- Started or changed dose of ACE inhibitor or angiotensin receptor blocker treatment within 4 weeks before screening
- Pregnant, breastfeeding, or planning pregnancy during the study
- History of HIV, hepatitis B or C infections
- Medical, emotional, behavioral, or psychological conditions interfering with study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Philippine General Hospital
Manila, Philippines
Actively Recruiting
2
St.Luke's Medical Center
Manila, Philippines
Actively Recruiting
3
Seoul Asan Center
Seoul, Songpa-gu, South Korea, 05505
Actively Recruiting
Research Team
B
Beomhee Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here