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Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia

Leukemia, Acute Clinical Trial

Official title:
Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia

Clinical Trial Summary

This study is designed to evaluate the safety, efficacy and Population Pharmacokinetics of Oral Posaconazole in Children with leukemia.

Clinical Trial Description

Posaconazole as a new triazole antifungal agent with broad spectrum coverage, was recommended for prophylaxis of invasive fungal disease in adults. Some studies have demonstrated the relationship between posaconazole plasma concentration and efficacy and few data have been published in children with leukemia.The purpose of this study is to describe the off-label use of posaconazole oral suspensions in children;to figure out the relationship between concentration and clinical outcomes/ adverse events;to identify factors that influence plasma concentration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04194086
Study type Interventional
Source Zhujiang Hospital
Contact
Status Completed
Phase Phase 1/Phase 2
Start date November 1, 2018
Completion date July 30, 2021
View Details
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