Rasburicase for Hyperuricemia - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 10, 2006

Last Updated Date

March 27, 2009

Start Date ^†

June 2005

Current 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.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00290992 on ClinicalTrials.gov Archive Site

Current 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.

Original Secondary Outcome Measures ^†

- Anti-SR29142 antibody and Anti-SCP antibody will be measured.
- 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.
- PK parameters.

Descriptive Information

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Parallel Assignment, Efficacy Study

Condition ^†

Nutritional and Metabolic Diseases

Intervention ^†

Drug: rasburicase (SR29142)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

April 2006

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

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.

Gender

Both

Ages

up to 17 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00290992

Responsible Party

Study director, sanofi-aventis

Secondary IDs ^††

Study Sponsor ^†

Sanofi-Aventis

Collaborators ^††

Investigators ^†

Study Director:

Keiji OHNO

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.