Rasburicase (Fasturtec) Registration Trial

Sponsor

Sanofi (Industry)

Overall Status

Terminated

CT.gov ID

NCT00607152

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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 ).

Condition or Disease	Intervention/Treatment	Phase
Hyperuricemia	Drug: Rasburicase Drug: Allopurinol	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 IV infusion at a dose level of 0.20mg/kg per day	Drug: Rasburicase 0.20mg/kg per day IV
Active Comparator: 2 100mg tablets, administered orally, according to standard medical practice	Drug: Allopurinol 100mg tablets

Arm

Intervention/Treatment

Experimental: 1

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

Drug: Rasburicase

0.20mg/kg per day IV

Active Comparator: 2

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

Drug: Allopurinol

100mg tablets

Outcome Measures

Primary Outcome Measures

Mean plasma uric acid AUC0-96 [0hour, 4hour, 12 hour and q12h thereafter]
Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing) [From administration of drug up to end of study]
Biochemistry, hematology, vital signs, physical examination, and adverse events [From administration of drug up to end of study]
Proportion of patients developing hypertension requiring therapy [From administration of drug up to end of study]
Assays for circulating antibodies [From administration of drug up to end of study]

Secondary Outcome Measures

Percentage reduction of plasma uric acid concentrations at T4h [From administration of drug up to end of study]
Mean plasma uric acid concentrations [At various timepoints]
Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL [From administration of drug up to end of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Shanghai		China

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Jing Fu, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT00607152

Other Study ID Numbers:

RASBU_L_00351

First Posted:

Feb 5, 2008

Last Update Posted:

May 8, 2014

Last Verified:

May 1, 2014

Additional relevant MeSH terms:

Hyperuricemia

Allopurinol

Rasburicase

Study Results

No Results Posted as of May 8, 2014