Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Savient Pharmaceuticals

Criteria

Inclusion Criteria:

• Previous treatment in studies of pegloticase i.v.

• Last exposure to pegloticase i.v. greater than one year prior to study entry

• Symptomatic gout

• Documented hyperuricemic (SUA ≥ 7 mg/dL)

Exclusion Criteria:

• Prior exposure to Elitek® (rasburicase)

• Unstable angina

• Uncontrolled arrhythmia or hypertension

• Non-compensated congestive heart failure

• End stage renal disease requiring dialysis

• Concomitant use of SUA lowering agents and use of other investigational drugs