CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 151 enrolled
Drug / intervention
pegloticasebiological
Likely dose
pegloticase 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01356498
NCT01356498Phase 3Completed
CompareCT.gov

Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout

Savient Pharmaceuticals·interventional·Posted May 19, 2011·Updated Dec 2, 2011

In Brief

A Phase 3 clinical trial evaluating pegloticase for Gout. Completed, enrolled 151 participants across 22 sites.

Detailed Summary

This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 19, 2011
Enrollment StartDec 1, 2006
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.1 years ago

Interventions

pegloticasebiological

8 mg intravenous infusion