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

NCT00921375 | Completed Phase 3

• 2 other identifiers: VB037/2007VB037
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, open-label, multicentre study. Hundred eligible patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a peripheral white blood cell (WBC) count of \> 25,000/µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dL 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.

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (1)

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

  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

Secondary Outcomes (2)

• Plasma uric acid AUC 0-96 hr

  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

• Incidence of adverse events

  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

Study Arms (1)

Tuly, uric acid lowering drug

EXPERIMENTAL

TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days

Drug: TULY

Interventions

TULY DRUG

TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days

Tuly, uric acid lowering drug

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both genders aged between 1 to 75 years;
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance scale of ≤3;
• Patients scheduled to receive chemotherapy.

You may not qualify if:

• Patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic reactions;
• Pregnant and lactating;
• Patients with glucose-6-phosphate dehydrogenase deficiency;
• Exposure to rasburicase or allopurinol within 7 days;
• History of psychiatric or co-morbid unstable medical conditions

Sponsors & Collaborators

• Virchow Group: lead

Study Sites (1)

Dr. Raghunathrao

Hyd, Andhra Pradesh, India

Location

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Raghunadharao D

  NIMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2009
• First Posted: June 16, 2009
• Study Start: February 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

IN (1)