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

Savient Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Chronic Gout Refractory to Conventional Therapy

Treatments: Drug: pegloticase 8 mg i.v.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00675103

C0409

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

pegloticase

Experimental group

Treatment:

Drug: pegloticase 8 mg i.v.