Rasburicase (Fasturtec) Registration Trial

NCT00607152 | Terminated Phase 3

• 1 other identifier: RASBU_L_00351
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 ).

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Rasburicase

2

ACTIVE COMPARATOR

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

Drug: Allopurinol

Interventions

Rasburicase DRUG

0.20mg/kg per day IV

1

Allopurinol DRUG

100mg tablets

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Shanghai, China

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

rasburicase; Allopurinol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jing Fu

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: October 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

CN (1)