6 completed, 1 terminated. 3 Phase 2, 3 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 3 | Completed 2, Terminated 1 |
| Phase 3 | 3 | Completed 3 |
| Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis Pegloticase - Chronic Kidney Disease Stage 5 | Phase 1 | Completed | Savient Pharmaceuticals | 12 | 2012-12-01 | 2013-10-25 |
| Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients pegloticase 8 mg i.v. - Chronic Gout Refractory to Conventional Therapy | Phase 3 | Completed | Savient Pharmaceuticals | 7 | 2008-05-01 | 2011-06-28 |
| Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout pegloticase - Gout | Phase 3 | Completed | Savient Pharmaceuticals | 151 | 2006-12-01 | 2011-12-02 |
| Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout placebo, pegloticase - Gout | Phase 3 | Completed | Savient Pharmaceuticals | 225 | 2006-05-01 | 2011-02-28 |
| Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout Pegloticase - Gout | Phase 2 | Completed | John Sundy | 30 | 2004-12-01 | 2014-10-03 |
| A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy Puricase - Gout | Phase 2 | Completed | Savient Pharmaceuticals | 40 | 2004-03-01 | 2013-06-03 |
| Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients prosaptide - HIV, Peripheral Nervous System Disorders | Phase 2 | Terminated | Savient Pharmaceuticals | 350 | 2003-09-01 | 2006-02-03 |
Gout (5) · Arthritis, Gouty (1) · Peripheral Nervous System Diseases (1) · Renal Insufficiency, Chronic (1)
Pegloticase (6) · prosaptide (1)
United States (6) · Canada (1) · Mexico (1)
Claudia Rehrig, MS (1) · Harry Alcorn, Pharm D (1) · John S. Sundy, MD, PhD (1)
PMID 24286509, PMID 24588936, PMID 31203212, PMID 17653259, PMID 18759308, PMID 20660758, PMID 21846852, PMID 24447425, PMID 24602182, PMID 31079535