Rasburicase for Hyperuricemia

NCT ID: NCT00290992

Last Updated: 2009-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2006-04-30

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.

Conditions

Nutritional and Metabolic Diseases

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

rasburicase (SR29142)

Intervention Type: DRUG

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.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Keiji OHNO

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Tokyo, , Japan

Countries

Japan

Other Identifiers

ACT5080

Identifier Type: -

Identifier Source: org_study_id