At a glance
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A Randomized, Double Blind, Active Control Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function in Patients With Fabry Disease Previously Treated With Agalsidase Beta
In Brief
A Phase 3 clinical trial evaluating PRX-102 (pegunigalsidase alfa) and agalsidase beta for Fabry Disease. Completed, enrolled 78 participants across 29 sites in 12 countries.
Detailed Summary
This was a randomized, double-blind, active control study of the enzyme replacement therapy (ERT) drug PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients who had been treated for approximately 1 year with agalsidase beta and who had been on a stable dose of that product for at least 6 months were randomized in a 2:1 ratio to either switch to PRX-102 or to continue treatment with agalsidase beta. Both treatments were delivered by intravenous infusions every two weeks, at a dosage of 1 mg/kg.
Study Details
Timeline
Interventions
PRX-102 1 mg/kg every 2 weeks
agalsidase beta 1 mg/kg every 2 weeks