NCT00675103

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

Multicenter, Open-Label, 24 Week Regimen of 8 mg Pegloticase i.v. in Symptomatic Gout Subjects Who Participated in Previous Studies of Pegloticase i.v.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Savient Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Gout Refractory to Conventional Therapy

Interventions

Type	Name	Description
DRUG	pegloticase 8 mg i.v.	pegloticase 8 mg i.v. every 2 weeks for 24 weeks

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-01-01
• Completion: 2009-04-01
• First posted: 2008-05-08
• Last updated: 2011-06-28
• Results posted: 2011-06-28

Locations

4 sites across 1 country: United States