Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin's Lymphoma and Acute Leukemia
- Registration Number
- NCT04349306
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To evaluate safety of rasburicase in pediatric patients with NHL and AL
Secondary Objective:
To assess efficacy of rasburicase for prevention and treatment of hyperuricemia
- Detailed Description
Study duration per participants is approximatively 14 days including a 5-day treatment period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description rasburicase RASBURICASE SR29142 rasburicase 0.20 mg/kg/day by intravenous (IV) over 30 minutes for 1 to 5 days according to the level of plasma uric acid or Investigator's clinical judgement
- Primary Outcome Measures
Name Time Method Incidence of AEs and SAEs Day 1 to Day 7 Incidence of AE or SAE will be summarized as the number and percentage of subjects who experienced any AE or SAE during the treatment period.
- Secondary Outcome Measures
Name Time Method Number of responders after completion of rasburicase treatment under chemotherapy Day 1 to Day 7 Response will be defined as achievement of normal uric acid levels (≤ 8.0 mg/dL) in those patients whose uric acid levels are \>8.0 mg/dL.
Proportion of patients who can maintain the normal uric acid levels throughout the study Day 1 to Day 7 In those patients whose baseline plasma uric acid levels are ≤ 8 mg/dL but with a high risk of TLS.
Percentage of the maximum decreasing degree of plasma uric acid level from baseline Day 1 to Day 7
Trial Locations
- Locations (1)
investigational site CHINA
🇨🇳China, China