Switch Over Study of Biosimilar Agalsidase Beta for Fabry Disease (NCT05843916) | Clinical Trial Compass
CompletedPhase 3
Switch Over Study of Biosimilar Agalsidase Beta for Fabry Disease
Argentina20 participantsStarted 2022-12-13
Plain-language summary
BIO-AGA-Fase III-001 is a Phase III, prospective, multicenter, open-label, single-group, baseline-controlled, switch over clinical trial to evaluate the efficacy and safety of AGA BETA BS in patients with FD already treated and previously stabilized with Fabrazyme®.
Who can participate
Age range16 Years – 60 Years
SexALL
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Inclusion criteria
✓. Male or female participant with ≥16 and ≤60 years of age at the time of signing the informed consent form (ICF).
✓. Female participants who are not pregnant, breastfeeding, donating eggs (ova, oocytes), or considering becoming pregnant during the study and for 3 months after the last dose of study treatment.
✓. All women of childbearing potential (WOCBP) must have a negative urine pregnancy test at the Screening visit and at Baseline visit (prior to the first dose of experimental intervention).
✓. WOCBP must use one highly effective form of birth control contraception through the study and for 3 months after the last dose of study treatment.
✓. Male participants who are not considering fathering a child during the study and for 3 months after the last dose of study treatment.
✓. Male sexually active participant with female partner(s) of childbearing potential must agree to use male condoms during the study and for 3 months after the last dose of study treatment or have documented successful surgical sterilization.
✓. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
✓. Confirmed previous diagnosis of FD.
Exclusion criteria
✕. Chronic kidney disease in stage 3b, 4, or 5.
✕. History of dialysis, kidney transplant or participants who are on the waiting list for a kidney transplant.
What they're measuring
1
Change From Baseline in Lyso Gb3 Serum Levels
Timeframe: Baseline (after 5 week lead-in period on Fabrazyme®) and 26 weeks (after the switch to AGA BETA BS)
✕. Participants who have suffered a clinical cardiovascular event (such as but not limited to myocardial infarction, transient ischemic attack) within 6 months prior to
✕. Participants who have clinically significant unstable cardiac disease (such as but not limited to uncontrolled symptomatic arrhythmia, unstable angina, congestive heart failure New York Heart Association class III or IV).
✕. Participants who have suffered a clinical cerebrovascular event (such as but not limited to stroke, transient ischemic attack) within 6 months prior to Screening visit.
✕. History of anaphylaxis or other type I hypersensitivity reactions to agalsidase beta.
✕. History of acute kidney injury in the 12 months prior to Screening visit (such as but not limited to acute interstitial nephritis, acute renal failure of glomerular origin or caused by vasculitis).