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Rasburicase (Fasturtec) Registration Trial

Primary Purpose

Hyperuricemia

Status

Terminated

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Rasburicase

Allopurinol

About this trial

This is an interventional treatment trial for Hyperuricemia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At high risk of malignancy and/or chemotherapy-induced hyperuricemia
Performance status less than 3 on ECOG scale or more than 30% KPS scale
Uric acid concentrations ≥ 8.0mg/dL
Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia

Exclusion Criteria:

Treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the Sponsor)
Pregnancy or lactation
Prior treatment with Uricozyme or Rasburicase
Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase
Treatment with Allopurinol within the seven days preceding study Day 1
History of significant atopic allergy problems or documented history of asthma
History of severe reaction to allopurinol
Known history of glucose-6-phosphate dehydrogenase deficiency.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

IV infusion at a dose level of 0.20mg/kg per day

100mg tablets, administered orally, according to standard medical practice

Outcomes

Primary Outcome Measures

Mean plasma uric acid AUC0-96

Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing)

Biochemistry, hematology, vital signs, physical examination, and adverse events

Proportion of patients developing hypertension requiring therapy

Assays for circulating antibodies

Secondary Outcome Measures

Percentage reduction of plasma uric acid concentrations at T4h

Mean plasma uric acid concentrations

Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL

Full Information

NCT ID

NCT00607152

First Posted

January 22, 2008

Last Updated

May 7, 2014

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00607152

Brief Title

Rasburicase (Fasturtec) Registration Trial

Official Title

A Multi-center, Randomized, Open-label, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Patients With Hematological Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Terminated

Why Stopped

the patient enrollment is too difficult

Study Start Date

October 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary: To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma. Secondary: To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperuricemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

IV infusion at a dose level of 0.20mg/kg per day

Arm Title

Arm Type

Active Comparator

Arm Description

100mg tablets, administered orally, according to standard medical practice

Intervention Type

Drug

Intervention Name(s)

Rasburicase

Intervention Description

0.20mg/kg per day IV

Intervention Type

Drug

Intervention Name(s)

Allopurinol

Intervention Description

100mg tablets

Primary Outcome Measure Information:

Title

Mean plasma uric acid AUC0-96

Time Frame

0hour, 4hour, 12 hour and q12h thereafter

Title

Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing)

Time Frame

From administration of drug up to end of study

Title

Biochemistry, hematology, vital signs, physical examination, and adverse events

Time Frame

From administration of drug up to end of study

Title

Proportion of patients developing hypertension requiring therapy

Time Frame

From administration of drug up to end of study

Title

Assays for circulating antibodies

Time Frame

From administration of drug up to end of study

Secondary Outcome Measure Information:

Title

Percentage reduction of plasma uric acid concentrations at T4h

Time Frame

From administration of drug up to end of study

Title

Mean plasma uric acid concentrations

Time Frame

At various timepoints

Title

Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL

Time Frame

From administration of drug up to end of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At high risk of malignancy and/or chemotherapy-induced hyperuricemia Performance status less than 3 on ECOG scale or more than 30% KPS scale Uric acid concentrations ≥ 8.0mg/dL Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia Exclusion Criteria: Treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the Sponsor) Pregnancy or lactation Prior treatment with Uricozyme or Rasburicase Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase Treatment with Allopurinol within the seven days preceding study Day 1 History of significant atopic allergy problems or documented history of asthma History of severe reaction to allopurinol Known history of glucose-6-phosphate dehydrogenase deficiency. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing Fu

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Shanghai

Country

China

12. IPD Sharing Statement

Learn more about this trial

Rasburicase (Fasturtec) Registration Trial

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