Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia
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
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
Yang Lihua
Clinical Professor
Zhujiang Hospital