CompletedPhase 2

Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout

United States30 participantsStarted 2004-12

Plain-language 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 chronic gout, who cannot tolerate, or have not responded adequately, to conventional therapy for gout. Funding Source - FDA OOPD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Reduction in Plasma Uric Acid to Less Than 6 mg/dL.

Timeframe: Baseline to Day 105

Trial details

NCT IDNCT00111657

SponsorJohn Sundy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-07

Results submitted2012-12-12

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