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A Randomized, Multicenter, Open-label, Comparison of Rasburicase (Fasturtec) Versus Allopurinol for the Prophylaxis and Treatment of Hyperuricemia in Chinese Patients With Leukaemia or Lymphoma


Phase 3
18 Years
50 Years
Not Enrolling
Both
Hyperuricemia

Thank you

Trial Information

A Randomized, Multicenter, Open-label, Comparison of Rasburicase (Fasturtec) Versus Allopurinol for the Prophylaxis and Treatment of Hyperuricemia in Chinese Patients With Leukaemia or Lymphoma


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Mean plasma uric acid AUC0-96

Outcome Time Frame:

0hour, 4hour, 12 hour and q12h thereafter

Safety Issue:

No

Principal Investigator

Jing Fu

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

China: Food and Drug Administration

Study ID:

RASBU_L_00351

NCT ID:

NCT00607152

Start Date:

October 2007

Completion Date:

January 2009

Related Keywords:

  • Hyperuricemia
  • Hyperuricemia

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