drugset / Trial / NCT03605212
Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults
Non-randomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to compare the exposure of febuxostat in pediatric patients (≥6\<18 years of age) and in adults suffering from hematological malignancies at intermediate to high risk of TLS and to compare the effect in terms of serum uric acid levels.
Timeline
- Start
- 2017-02-27
- Primary completion
- 2018-07-25
- Completion
- 2018-07-25
Outcome
Outcome not reported
Stopped: “The study was stopped as per EMA waiver granted on 20July2018.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Febuxostat | Small molecule | 40 mg | Oral |
| Subject | Febuxostat | Small molecule | 60 mg | Oral |
| Subject | Febuxostat | Small molecule | 80 mg | Oral |
| Subject | Febuxostat | Small molecule | 120 mg | Oral |