- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00563771
Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome
January 24, 2008 updated by: Sanofi
Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of
- Sanofi-Aventis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Choe Seong Choon, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion
December 6, 2022
Study Completion (Actual)
January 1, 2004
Study Registration Dates
First Submitted
November 21, 2007
First Submitted That Met QC Criteria
November 21, 2007
First Posted (Estimate)
November 26, 2007
Study Record Updates
Last Update Posted (Estimate)
January 28, 2008
Last Update Submitted That Met QC Criteria
January 24, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L_8720
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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