Status:
COMPLETED
Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout
Lead Sponsor:
John Sundy
Collaborating Sponsors:
Savient Pharmaceuticals
Conditions:
Gout
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether PEG-uricase (a chemically modified recombinant mammalian enzyme that degrades uric acid) is effective in controlling hyperuricemia in patients with ch...
Detailed Description
Inflammatory arthritis in patients with gout is caused by crystals of monosodium urate (MSU) that form as a result of chronically elevated levels of uric acid in plasma and extracellular fluids. Recur...
Eligibility Criteria
Inclusion
- Age \>18 years
- Symptomatic gout
- Serum uric acid \>7 mg/dL
- Intolerance of, or inadequate response to, conventional therapy for gout
- Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method
Exclusion
- End stage renal failure that requires dialysis
- Concurrent use of uric-acid lowering agents
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- A history of anaphylactic reaction to a recombinant protein
- Concurrent use of immunosuppressive therapy (except as needed for prevention of rejection of a transplanted organ, or prednisone at 10 mg a day or less for treatment of gout flares)
- A medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00111657
Start Date
December 1 2004
End Date
July 1 2009
Last Update
October 3 2014
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710