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OpenTrials
Completed

NCT Number: NCT00290992

Rasburicase for Hyperuricemia

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rasburicase (SR29142)

Drug

Primary outcomes

  1. 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 outcomes

  1. Safety will be assessed on clinical observation, laboratory test, vital sign (blood pressure, pulse rate and body temperature), and the occurrence of adverse events.

  2. G6PD activity will be measured in only patients who demonstrate hemolysis.

  3. Anti-SR29142 antibody and Anti-SCP antibody will be measured.

  4. PK parameters.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 13, 2006
Registry last updated
Mar 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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