To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01 and PB-102-F02.
An open-label study to evaluate the ongoing safety, tolerability and efficacy parameters of PRX-102 in adult Fabry patients (≥18 years of age). Patients enrolled received 1.0 mg/kg of PRX-102 as an intravenous infusion every 2 weeks (+/- 3 days) for up to 60 months and no less than 36 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
PRX-102 1 mg/kg every 2 weeks
University of Florida
Gainesville, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Institute of Metabolic Disease
Dallas, Texas, United States
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Results represent the number of treatment-emergent adverse events (TEAE) that were considered definitely, probably or possibly related to study treatment.
Time frame: Every two weeks up to 60 months
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O & O Alpan
Fairfax, Virginia, United States
Instituto Privado de Hematologia E Investigacion Clinica (I.P.H.I.C)
Asunción, Paraguay
Hospital de Dia Quiron Zaragoza
Zaragoza, Spain
The Royal Free Hospital
London, United Kingdom