Rasburicase for Hyperuricemia

Nutritional and Metabolic Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290992
• Other study ID #: ACT5080
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2006
• Last updated: March 27, 2009
• Start date: June 2005
• Est. completion date: April 2006

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperuricemia
• Metabolic Diseases
• Nutritional and Metabolic Diseases

Intervention

Drug:
• rasburicase (SR29142)

Locations

Country	Name	City	State
Japan	Sanofi-Aventis	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

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