Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout

Exclusion Criteria

• •1. The patient has unstable angina.
• •2. The patient has uncontrolled arrhythmia.
• •3. The patient has non-compensated congestive heart failure.
• •4. The patient has uncontrolled hypertension (above 150/95).
• •5. The patient has a history of end stage renal disease requiring dialysis.
• •6. The patient has hemoglobin \< 8 g/dL (males) or \< 7 g/dL (females).
• •7. The patient is an organ transplant recipient
• •8. The patient has had prior treatment with PEG-uricase, or other recombinant uricase, or any concomitant therapy with a PEG-conjugated drug.
• •9. The patient has had a gout flare at screening that is resolved for less than one week prior to first treatment with study drug (exclusive of chronic synovitis/ arthritis).
• •10. The patient has glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• •11. The patient has a history of anaphylactic reaction to a recombinant protein or porcine product, or hypersensitivity to PEG.
• •12. The patient is pregnant or breast feeding.
• •13. The patient has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study.
• •14. The patient has a known allergy to urate oxidase or PEGylated products.
• •15. The patient has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.