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CompletedNCT00302653Updated Sep 25, 2009

Rasburicase in Tumor Lysis Syndrome

A Phase 4 interventional study of Rasburicase in Hyperuricemia, sponsored by Sanofi. Completed at 1 site in Brazil. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2009-09-25.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
33
Allocation
Non-randomized
Ages
Up to 18 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether rasburicase is effective and safety in correcting hyperuricemia.

02

Conditions studied

  • Hyperuricemia

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03

In context

Hyperuricemia

215 studies on the registry are indexed under Hyperuricemia; 40 are open to participants now.

This study's enrollment of 33 is below the median of 64 across 172 interventional studies indexed under Hyperuricemia.

Browse Hyperuricemia studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

List of inclusion Criteria:

  • Acute hyperuricemia patients(uric acid>8.0 mg/dl) before/during chemotherapy for hematologic malignancies.

List of exclusion Criteria:

  • Hypersensitivity to uricases or any of the excipients.
  • Known history of hemolytic anemia (G6PD deficiency).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    1

    Rasburicase 0,20mg/Kg/Day once a day 3-7 days

    Drug: Rasburicase

Interventions

  • DrugRasburicase

    Rasburicase 0,20mg/Kg/Day once a day 3-7 days

06

What researchers measure

Primary outcomes

  1. Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)

    Time frame: 24-48 hours after last dose of rasburicase

  2. Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)

    Time frame: 28 (+- 3) days after the last dose of rasburicase

  3. Adverse events occurrence

    Time frame: During the study

07

Study locations

1 site
  • Sanofi-aventis administrative office
    São Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00302653
Lead sponsor
Sanofi
First posted
Mar 14, 2006
Start date
Feb 2006
Primary completion
Nov 2006
Last update
Sep 25, 2009

Study contacts

Jaderson Lima
study director · Sanofi-aventis administrative office Brazil
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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