Skip to main content
Clinical Trials/NCT04194086
NCT04194086CompletedPhase 1

Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia

Zhujiang Hospital1 site in 1 country42 target enrollmentStarted: November 1, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
42
Locations
1
Primary Endpoint
Plasma posaconazole concentration monitoring and its pharmacokinetic

Study Overview

Brief Summary

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

Detailed 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

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 1、Patients age 2-14 years with acute leukemia (AML, ALL) undergoing chemotherapy and neutropenia expected to last at least 7 days.
  • 2、Karnofsky/Lansky score of 60% or greater. 3、defined as alanine transaminase (ALT) <3 x upper limit of normal (ULN),aspartate aminotransferase (AST) <3 x ULN; serum bilirubin and alkaline phosphatase <2 x ULN.
  • 4、No other treatment and combination of triazoles antifungals and drugs like vincristine, sirolimus, cyclosporine etc.
  • 5、Able to take oral medication or take medication via enteral feeding tube. 6、Ability to give informed consent. 7、No history of anaphylaxis attributed to the azole class of antifungal agents.

Exclusion Criteria

  • 1、Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction.
  • 2、Subject is not considered eligible for this clinical research program with posaconazole.
  • 3、Use of medications that are known to interact with posaconazole and that may lead to life-threatening side to effects.

Arms & Interventions

posaconazole as antifungal prophylaxis

Experimental

Intervention: posaconazole oral suspensions (Drug)

Outcomes

Primary Outcomes

Plasma posaconazole concentration monitoring and its pharmacokinetic

Time Frame: 1 year

Blood samples for determination of plasma posaconazole concentration will be collected predoses (just prior to a daily dose) on days 3, 7, 14 and 21. Anther concentration (include peak concentraton) will also be collected at least 7days after the first dose.

Number, type and grade of adverse events of posaconazole assessed by CTCAE v4.0

Time Frame: 1 year

Number, type and grade of adverse events of posaconazole oral suspensions to children with leukemia assessed by CTCAE v4.0.

Secondary Outcomes

  • Serious Adverse events and drug-related adverse events monitoring(2 years)

Investigators

Sponsor
Zhujiang Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yang Lihua

Clinical Professor

Zhujiang Hospital

Study Sites (1)

Loading locations...

Similar Trials

Population Pharmacokinetics and Safety of... | Clinical Trial