NCT00302653

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Last Updated

September 25, 2009

Status Verified

September 1, 2009

Enrollment Period

9 months

First QC Date

March 10, 2006

Last Update Submit

September 24, 2009

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (3)

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

    24-48 hours after last dose of rasburicase

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

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

  • Adverse events occurrence

    During the study

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Rasburicase

Interventions

RasburicaseDRUG

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

1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis administrative office

São Paulo, Brazil

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

rasburicase

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jaderson Lima

    Sanofi-aventis administrative office Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 10, 2006

First Posted

March 14, 2006

Study Start

February 1, 2006

Primary Completion

November 1, 2006

Last Updated

September 25, 2009

Record last verified: 2009-09

Locations

BR(1)