NCT00563771

Brief Summary

To provide treatment opportunity to children and adolescent patients with hematologic malignancies by supplying the delayed marketed product and also to observe the efficacy and safety of rasburicase used in the treatment of hyperuricemia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2003

Shorter than 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

March 1, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

January 28, 2008

Status Verified

January 1, 2008

First QC Date

November 21, 2007

Last Update Submit

January 24, 2008

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (1)

  • Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL)

Interventions

RasburicaseDRUG

Eligibility Criteria

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

You may qualify if:

  • Acute hyperuricemia patients before / during chemotherapy for hematologic malignancies ( uric acid greater than 7.5 mg/dL )
  • With a minimum life expectancy of 3 months
  • Having previously signed a written informed consent.

You may not qualify if:

  • Hypersensitivity to uricase or any of the excipients.
  • Known history of G6PD deficiency.
  • Previous treatment with Rasburicase or Uricozyme.
  • Treatment with any investigational drug within 30 days before planned first Rasburicase administration.
  • 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

Seoul, South Korea

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

rasburicase

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Choe Seong Choon

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

March 1, 2003

Study Completion

January 1, 2004

Last Updated

January 28, 2008

Record last verified: 2008-01

Locations

KR(1)