CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Pegloticasebiological
Likely dose
Pegloticase 8 mg intravenously every 3 weeks for 5 infusionsAI-extracted
Key inclusion· 4
  • ✓Age >18 years
  • ✓Symptomatic gout
  • ✓Serum uric acid >7 mg/dL
  • ✓Intolerance of or inadequate response to conventional gout therapy
Key exclusion· 5
  • ✕End stage renal failure requiring dialysis
  • ✕Concurrent use of uric-acid lowering agents
  • ✕Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • ✕History of anaphylactic reaction to a recombinant protein

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00111657
NCT00111657Phase 2Completed
CompareCT.gov

A Phase II Multidose Study of Intravenous PEG-uricase in Patients With Refractory Gout

John Sundy·interventional·Posted May 25, 2005·Updated Oct 3, 2014

In Brief

A Phase 2 clinical trial evaluating Pegloticase for Gout. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether PEG-uricase (a chemically modified recombinant mammalian enzyme that degrades uric acid) is effective in controlling hyperuricemia in patients with chronic gout, who cannot tolerate, or have not responded adequately, to conventional therapy for gout. Funding Source - FDA OOPD

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesUnited States
CollaboratorsSavient Pharmaceuticals

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 25, 2005
Enrollment StartDec 1, 2004
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 21.1 years ago

Interventions

Pegloticasebiological

8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5