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| Tracking Information | |||||
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| First Received Date ICMJE | April 18, 2008 | ||||
| Last Updated Date | March 27, 2009 | ||||
| Start Date ICMJE | July 2002 | ||||
| Primary Completion Date | January 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
responder rate (based on normalization of uric acid levels) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00664144 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma | ||||
| Official Title ICMJE | Study of Efficacy and Safety of Rasburicase for the Treatment/Prevention of Hyperuricemia Related to Tumor Lysis Syndrome in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma, Previously Treated or Not With Urate Oxidase Presenting With Hyperuricemia and/or Bulky Disease | ||||
| Brief Summary | The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult patients, previously treated or not with urate oxidase, with relapsing aggressive non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky disease at diagnostic of relapse. The secondary objectives were to :
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Efficacy Study | ||||
| Condition ICMJE | Hyperuricemia | ||||
| Intervention ICMJE | Drug: Rasburicase (SR29142) | ||||
| 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 | Terminated | ||||
| Enrollment ICMJE | 33 | ||||
| Completion Date | January 2005 | ||||
| Primary Completion Date | January 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Patients with histologically proven aggressive Non Hodgkin's Lymphoma |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium, France, Germany, Italy | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00664144 | ||||
| Responsible Party | ICD Study Director, Sanofi-aventis | ||||
| Study ID Numbers ICMJE | EFC4983, L 8433 | ||||
| Study Sponsor ICMJE | Sanofi-Aventis | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Sanofi-Aventis | ||||
| Verification Date | March 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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