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Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia


Phase 3
1 Year
75 Years
Open (Enrolling)
Both
Hyperuricemia

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Trial Information

Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia


All eligible patients will be treated with rasburicase 0.20 mg/kg body weight intravenously
for 4 days. The primary endpoints viz., the percentage of reduction in plasma uric acid at
4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and incidence of
adverse events will be assessed during 11 days study period.


Inclusion Criteria:



1. Patients of both genders aged between 1 to 75 years;

2. Patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic
leukemia (ALL) with a peripheral WBC count of >25,000/µL or any leukemia or
lymphoma with plasma uric acid level of at least 8 mg/dL;

3. Eastern Cooperative Oncology Group (ECOG) performance scale of ≤3;

4. Patients scheduled to receive chemotherapy.

Exclusion Criteria:

1. Patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic
reactions;

2. Pregnant and lactating;

3. Patients with glucose-6-phosphate dehydrogenase deficiency;

4. Exposure to rasburicase or allopurinol within 7 days;

5. History of psychiatric or co-morbid unstable medical conditions

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy

Outcome Time Frame:

At the end of 4 hrs after initiation of uric acid lowering therapy; during 96 hrs of uric acid lowering therapy; Adverse events during the entire study period

Safety Issue:

Yes

Principal Investigator

Dr. Raghunadharao D

Investigator Role:

Principal Investigator

Investigator Affiliation:

NIMS

Authority:

India: Drugs Controller General of India

Study ID:

VB037/2007

NCT ID:

NCT00921375

Start Date:

June 2009

Completion Date:

December 2009

Related Keywords:

  • Hyperuricemia
  • Hyperuricemia

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