NCT00664144

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 :

  • evaluate the efficacy of rasburicase in terms of renal protection,
  • evaluate the safety of rasburicase in the two cohorts of patients,
  • correlate efficacy and safety results with antibodies generation/level.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2002

Geographic Reach
4 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

2.5 years

First QC Date

April 18, 2008

Last Update Submit

March 6, 2012

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (1)

  • responder rate (based on normalization of uric acid levels)

Interventions

Rasburicase (SR29142)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Patients with histologically proven aggressive Non Hodgkin's Lymphoma

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Sanofi-Aventis Administrative Office

Diegem, Belgium

Location

Sanofi- Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

Berlin, Germany

Location

Sanofi-Aventis Administrative Office

Milan, Italy

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

rasburicaseUrate Oxidase

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OxidoreductasesEnzymesEnzymes and Coenzymes

Study Officials

  • ICD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 22, 2008

Study Start

July 1, 2002

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

DE(1)BE(1)IT(1)FR(1)