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

Hyperuricemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921375
• Other study ID #: VB037/2007
• Secondary ID: VB037
• Status: Completed
• Phase: Phase 3
• First received: May 23, 2009
• Last updated: December 11, 2014
• Start date: February 2010
• Est. completion date: January 2012

Study information

• Verified date: December 2014
• Source: Virchow Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

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

Locations

Country	Name	City	State
India	Dr. Raghunathrao	Hyd	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Virchow Group

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes