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

Primary Purpose

Hyperuricemia

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
TULY
Sponsored by
Virchow Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperuricemia

Eligibility Criteria

1 Year - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Raghunathrao

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tuly, uric acid lowering drug

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Plasma uric acid AUC 0-96 hr
Incidence of adverse events

Full Information

First Posted
May 23, 2009
Last Updated
December 11, 2014
Sponsor
Virchow Group
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1. Study Identification

Unique Protocol Identification Number
NCT00921375
Brief Title
Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia
Official Title
Efficacy and Safety of TULY in Prevention and Treatment of Malignancy-associated Hyperuricemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virchow Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tuly, uric acid lowering drug
Arm Type
Experimental
Arm Description
TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days
Intervention Type
Drug
Intervention Name(s)
TULY
Intervention Description
TULY (rasburicase) 0.20 mg/kg body weight intravenously for 4 days
Primary Outcome Measure Information:
Title
Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy
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
Secondary Outcome Measure Information:
Title
Plasma uric acid AUC 0-96 hr
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
Title
Incidence of adverse events
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Raghunadharao D
Organizational Affiliation
NIMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Raghunathrao
City
Hyd
State/Province
Andhra Pradesh
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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