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Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194086
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Guangdong Provincial People's Hospital
Information provided by (Responsible Party):
Yang Lihua, Zhujiang Hospital

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

Condition or disease Intervention/treatment Phase
Leukemia, Acute Drug: posaconazole oral suspensions Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: posaconazole as antifungal prophylaxis Drug: posaconazole oral suspensions
posaconazole oral suspensions(5mg/kg/d,tid) will be administered specially febrile neutropenia patients four times a day and blood samples will be taken any hours after the first dose at least Day 7.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Serious Adverse events and drug-related adverse events monitoring [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194086


Contacts
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Contact: yang lihua, PhD 0086-13580532469 dryanglihua@163.com
Contact: yu lihua 0086-13414125621 eveylh@163.com

Locations
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China, Guangdong
Zhujiang Hospital of Southern Medical University Recruiting
Guanzhou, Guangdong, China
Contact: zhang tingting    0086-020-61643022    zjyyllwyh@126.com   
Sponsors and Collaborators
Zhujiang Hospital
Guangdong Provincial People's Hospital
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Responsible Party: Yang Lihua, Clinical Professor, Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT04194086    
Other Study ID Numbers: 2018-EKZX-003
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms
Posaconazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs