Last updated on March 2019

Safety and Efficacy of PRX 102 in Patients With Fabry Disease Currently Treated With REPLAGAL (Agalsidase Alfa)


Brief description of study

This is an open label switch over study to assess the safety and efficacy of PRX-102 (pegunigalsidase alfa). Patients treated with agalsidase alfa for at least 2 years and on a stable dose (>80% labelled dose/kg) for at least 6 months. Patients will be screened and evaluated over 3 months while continuing on agalsidase alfa. Following the screening period, the patient will be enrolled and switched from their agalsidase alfa treatment to receive intravenous (IV) infusions of PRX-102 1 mg/kg every two weeks for 12 months. No more than 25% of treated patients will be female.

Clinical Study Identifier: NCT03018730

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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