drugset / Trial / NCT02598596

Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect

NCT02598596

Phase 2 Completed 132 enrolled Ampel BioSolutions, LLC IND 2 Results LLC · collab
Non-randomizedSingle-groupOpen-labelOther

Summary

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.

Timeline

Start
2015-12
Primary completion
2020-04-13
Completion
2020-04-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegloticase Protein / enzyme biologic 8 mg Intravenous
Background Azathioprine Small molecule 2.5 mg/kg Oral

Indications