Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
Completed
Savient Pharmaceuticals
Phase 3
2008-05-01
The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24
week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase
i.v. was at least one year before study entry.
This study is limited to four study centers in the US.
Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
Completed
Savient Pharmaceuticals
Phase 1
2012-12-01
This is a Phase 1 single dose study conducted to evaluate the PK and PD of pegloticase
administered to hemodialysis patients.
A single dose of pegloticase will be administered intravenously to male or female
hemodialysis patients (N = 12) starting 3 hour prior to dialysis.
The study consists of a Screening Period, a Treatment Period, and Follow up Period.
Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect
Completed
IND 2 Results LLC
Phase 2
2015-12-01
The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of
pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in patients
with chronic, refractory gout.
Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect
Completed
Ampel BioSolutions, LLC
Phase 2
2015-12-01
The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of
pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in patients
with chronic, refractory gout.
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