CLINICAL TRIALS PROFILE FOR PEGLOTICASE
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All Clinical Trials for pegloticase
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00675103 ↗ | 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. |
| NCT01739660 ↗ | 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. |
| NCT02598596 ↗ | 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. |
| NCT02598596 ↗ | 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. |
| NCT03303989 ↗ | REduCing Immunogenicity to PegloticasE (RECIPE) Study | Completed | University of Michigan | Phase 2 | 2018-06-14 | Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to investigate the question of whether a short course of immune modulating therapy with mycophenolate mofetil can significantly and safely attenuate immunogenicity to pegloticase and ensure patients afflicted with chronic refractory gout have better treatment outcomes and improved quality of life. |
| NCT03303989 ↗ | REduCing Immunogenicity to PegloticasE (RECIPE) Study | Completed | University of Alabama at Birmingham | Phase 2 | 2018-06-14 | Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to investigate the question of whether a short course of immune modulating therapy with mycophenolate mofetil can significantly and safely attenuate immunogenicity to pegloticase and ensure patients afflicted with chronic refractory gout have better treatment outcomes and improved quality of life. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for pegloticase
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Clinical Trial Progress for pegloticase
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Clinical Trial Sponsors for pegloticase
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