CompletedPhase 3

Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

United States280 participantsStarted 2004-04

Plain-language summary

This is a randomized, multi-center, open-label, parallel group study with three arms: * Rasburicase alone * Rasburicase followed by Allopurinol * Allopurinol alone The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Meets high risk or at potential risk for tumor lysis syndrome (TLS):
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
✓. Age \>= 18 years
✓. Life expectancy \> 3 months
✓. Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
✓. Signed written informed consent

What they're measuring

Plasma Uric Acid Responder

Timeframe: Day 3 through Day 7

Trial details

NCT IDNCT00230178

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-12

Results submitted2009-07-22

View on ClinicalTrials.gov More Tumor Lysis Syndrome trials