Trials / Completed
CompletedNCT04349306
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
An Open-label, Single-arm, Multi-center Study to 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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RASBURICASE SR29142 | Pharmaceutical form:solution for infusion Route of administration: intravenous |
Timeline
- Start date
- 2020-05-14
- Primary completion
- 2021-03-12
- Completion
- 2021-03-12
- First posted
- 2020-04-16
- Last updated
- 2022-04-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04349306. Inclusion in this directory is not an endorsement.