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Rasburicase (Fasturtec) Registration Trial

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperuricemia

Intervention: Rasburicase (Drug); Allopurinol (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Jing Fu, Study Director, Affiliation: Sanofi

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 ).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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:

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

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Locations and Contacts

Sanofi-Aventis Administrative Office, Shanghai, China
Additional Information

Starting date: October 2007
Last updated: May 7, 2014

Page last updated: August 23, 2015

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