drugset / Trial / NCT03605212

Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults

NCT03605212

Phase 1/2 Terminated 30 enrolled Menarini Group
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

Drugs

EvaluationDrugModalityDoseRoute
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

Indications