Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia (NCT04194086) | Clinical Trial Compass
CompletedPhase 1/2
Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia
China42 participantsStarted 2018-11-01
Plain-language summary
This study is designed to evaluate the safety, efficacy and Population Pharmacokinetics of Oral Posaconazole in Children with leukemia.
Who can participate
Age range2 Years â 14 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1ãPatients age 2-14 years with acute leukemia (AML, ALL) undergoing chemotherapy and neutropenia expected to last at least 7 days.
2ãKarnofsky/Lansky score of 60% or greater. 3ãdefined 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.
4ãNo other treatment and combination of triazoles antifungals and drugs like vincristine, sirolimus, cyclosporine etc.
5ãAble to take oral medication or take medication via enteral feeding tube. 6ãAbility to give informed consent. 7ãNo history of anaphylaxis attributed to the azole class of antifungal agents.
Exclusion Criteria:
* 1ãExisting severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction.
2ãSubject is not considered eligible for this clinical research program with posaconazole.
3ãUse of medications that are known to interact with posaconazole and that may lead to life-threatening side to effects.
What they're measuring
1
Number, type and grade of adverse events of posaconazole assessed by CTCAE v4.0
Timeframe: 1 year
2
Plasma posaconazole concentration monitoring and its pharmacokinetic