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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00664144 |
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 :
Condition | Intervention | Phase |
---|---|---|
Hyperuricemia |
Drug: Rasburicase (SR29142) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Efficacy Study |
Official Title: | 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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients with histologically proven aggressive Non Hodgkin's Lymphoma
Belgium | |
Sanofi-Aventis Administrative Office | |
Diegem, Belgium | |
France | |
Sanofi- Aventis Administrative Office | |
Paris, France | |
Germany | |
Sanofi-Aventis Administrative Office | |
Berlin, Germany | |
Italy | |
Sanofi-Aventis Administrative Office | |
Milan, Italy |
Study Director: | ICD | Sanofi-Aventis |
Responsible Party: | Sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC4983, L 8433 |
Study First Received: | April 18, 2008 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00664144 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Lymphatic Diseases Uric Acid Immunoproliferative Disorders Lymphoma, small cleaved-cell, diffuse Hyperuricemia Tumor Lysis Syndrome |
Lymphoproliferative Disorders Aggression Lymphoma, Non-Hodgkin Rasburicase Lymphoma |
Neoplasms Pathologic Processes Neoplasms by Histologic Type Immune System Diseases |
Therapeutic Uses Antirheumatic Agents Gout Suppressants Pharmacologic Actions |