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Rasburicase for Hyperuricemia

Primary Purpose

Nutritional and Metabolic Diseases

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
rasburicase (SR29142)
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutritional and Metabolic Diseases focused on measuring urate oxidase, hyperuricemia, lymphoma, leukemia

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: <18 years of age Patient with newly diagnosed hematological malignancies presenting with hyperuricemia: Uric acid > 7.5 mg/dL in patients ≥ 13 years old- Uric acid > 6.5mg/dL in patients <13 years old Or, patient with newly diagnosed hematological malignancies presenting with high tumor burden defined: Non-Hodgkin's lymphoma, Stage IV regardless of uric acid level, Non-Hodgkin's Lymphomas stage III regardless of uric acid level with one of the following: At least one lymph node or mass >5 cm in diameter LDH ≥ 3 x ULN (IU/L): Judging according to modified Murphy's classification Acute leukemia with white blood cell count (WBC) ≥ 50,000/mm3 or LDH ≥ 3 x ULN (IU/L) regardless of uric acid level. etc. Exclusion Criteria: Patients who have received or are scheduled to receive other investigational drugs in 30 days prior to the start of SR29142 administration or during the trial period. Low birth weight infant (<2500g) or gestational age <37 weeks Patients who have received or are scheduled allopurinol within 72 hrs prior to the first dose of SR29142 or during the trial period. Known history of severe allergic reaction and/or severe asthma. Known history or family history of glucose-6-phosphate dehydrogenase deficiency. Known history of hemolysis and methemoglobinemia. Severe disorders of liver or kidney. ALT (GPT) > 5.0 x ULN, Total Bilirubin > 3.0 x ULN, Creatinine > 3.0 x ULN Uncontrollable infections (including viral infections). Known positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies. etc.

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

Patients with a plasma uric acid level decreased to the endpoint by 48 hr after the start of first drug infusion and lasting until 24 hr after the start of final (Day 5) drug infusion.

Secondary Outcome Measures

Safety will be assessed on clinical observation, laboratory test, vital sign (blood pressure, pulse rate and body temperature), and the occurrence of adverse events.
G6PD activity will be measured in only patients who demonstrate hemolysis.
Anti-SR29142 antibody and Anti-SCP antibody will be measured.
PK parameters.

Full Information

First Posted
February 10, 2006
Last Updated
March 27, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00290992
Brief Title
Rasburicase for Hyperuricemia
Official Title
Open-Label, Multi-Center Study of SR29142 as Uricolytic Therapy/Prophylaxis for Hyperuricemia in Pediatric Patients With Newly Diagnosed Hematological Malignancies at High Risk for Tumor Lysis Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentration. Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP antibodies, and pharmacokinetic parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional and Metabolic Diseases
Keywords
urate oxidase, hyperuricemia, lymphoma, leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rasburicase (SR29142)
Primary Outcome Measure Information:
Title
Patients with a plasma uric acid level decreased to the endpoint by 48 hr after the start of first drug infusion and lasting until 24 hr after the start of final (Day 5) drug infusion.
Secondary Outcome Measure Information:
Title
Safety will be assessed on clinical observation, laboratory test, vital sign (blood pressure, pulse rate and body temperature), and the occurrence of adverse events.
Title
G6PD activity will be measured in only patients who demonstrate hemolysis.
Title
Anti-SR29142 antibody and Anti-SCP antibody will be measured.
Title
PK parameters.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: <18 years of age Patient with newly diagnosed hematological malignancies presenting with hyperuricemia: Uric acid > 7.5 mg/dL in patients ≥ 13 years old- Uric acid > 6.5mg/dL in patients <13 years old Or, patient with newly diagnosed hematological malignancies presenting with high tumor burden defined: Non-Hodgkin's lymphoma, Stage IV regardless of uric acid level, Non-Hodgkin's Lymphomas stage III regardless of uric acid level with one of the following: At least one lymph node or mass >5 cm in diameter LDH ≥ 3 x ULN (IU/L): Judging according to modified Murphy's classification Acute leukemia with white blood cell count (WBC) ≥ 50,000/mm3 or LDH ≥ 3 x ULN (IU/L) regardless of uric acid level. etc. Exclusion Criteria: Patients who have received or are scheduled to receive other investigational drugs in 30 days prior to the start of SR29142 administration or during the trial period. Low birth weight infant (<2500g) or gestational age <37 weeks Patients who have received or are scheduled allopurinol within 72 hrs prior to the first dose of SR29142 or during the trial period. Known history of severe allergic reaction and/or severe asthma. Known history or family history of glucose-6-phosphate dehydrogenase deficiency. Known history of hemolysis and methemoglobinemia. Severe disorders of liver or kidney. ALT (GPT) > 5.0 x ULN, Total Bilirubin > 3.0 x ULN, Creatinine > 3.0 x ULN Uncontrollable infections (including viral infections). Known positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies. etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keiji OHNO
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Tokyo
Country
Japan

12. IPD Sharing Statement

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Rasburicase for Hyperuricemia

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