|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 28, 2005 | ||||
| Last Updated Date | March 27, 2009 | ||||
| Start Date ICMJE | March 2004 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Positive response based on plasma uric acid levels. [ Time Frame: up to 48 hours after last administration. ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00230217 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
safety assessment | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy | ||||
| Official Title ICMJE | Evaluation of Single Agent Rasburicase in Treatment/Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Adult and Pediatric Patients With Lymphoma/Leukemia/Solid Tumor Malignancies at Their First Relapse or Refractory Disease | ||||
| Brief Summary | This is an open-label, multi-center study with 2 arms. The primary objective is to assess the response to treatment with rasburicase in 2 populations of adult and pediatric patients with lymphoma/leukemia/solid tumor malignancies, those previously treated with a uricolytic agent, and those not previously treated with a uricolytic agent at their first relapse or refractory disease. |
||||
| Detailed Description | This is a multi-center, 2 arm, open-label study;
Patients receive rasburicase for 5 days and begin chemotherapy 4-24 hours after the first dose of rasburicase. Patients are followed at 14 and 35 days, at 3 and 6 months and every 6 months thereafter. |
||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Drug: Rasburicase (SR29142) | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 94 | ||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00230217 | ||||
| Responsible Party | ICD Study Director, sanofi-aventis | ||||
| Study ID Numbers ICMJE | EFC5339 | ||||
| Study Sponsor ICMJE | Sanofi-Aventis | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Sanofi-Aventis | ||||
| Verification Date | March 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||