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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | November 4, 2009 | ||||
| Start Date ICMJE | March 2005 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of grade 3 or 4 allergic reactions [ Time Frame: Within 30 days of last treatment administration ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Incidence of grade 3 or 4 allergic reactions | ||||
| Change History | Complete list of historical versions of study NCT00186940 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE |
Reduction in uric acid levels, renal failure | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients | ||||
| Official Title ICMJE | A Study of Rasburicase Treatment for Chemotherapy of Malignancy-Induced Hyperuricemia in Patients With a History of Asthma Allergies | ||||
| Brief Summary | This is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome who have a history of asthma/atopy. The main purpose of this study is to establish the safety of this drug in patients with a history of asthma or severe allergies. |
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| Detailed Description | Because they were excluded from most of the clinical trials of non-recombinant urate oxidase and rasburicase, the safety of rasburicase in this population is not known, though preliminary data indicates that the drug is safe. The primary objective of this study is to estimate the proportion of grade 3 or 4 allergic reactions to rasburicase in patients with a history of asthma or severe allergy (to antigens other than rasburicase or other urate oxidases) treated with rasburicase for the prevention or treatment of malignancy or chemotherapy-induced hyperuricemia. Patients at risk of tumor lysis syndrome with a history of asthma/atopy will be treated with rasburicase according to standard practice and observed for allergic reactions. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Other, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Rasburicase | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 72 | ||||
| Estimated Completion Date | December 2009 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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| 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 | NCT00186940 | ||||
| Responsible Party | Raul C. Ribeiro, Principal Investigator, St. Jude Children's Research Hospital | ||||
| Study ID Numbers ICMJE | RASALL | ||||
| Study Sponsor ICMJE | St. Jude Children's Research Hospital | ||||
| Collaborators ICMJE | Sanofi-Aventis | ||||
| Investigators ICMJE |
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| Information Provided By | St. Jude Children's Research Hospital | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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