Clinical trial · Interventional
Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia
NCT04194086CI-TRIAL-00053049completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to evaluate the safety, efficacy and Population Pharmacokinetics of Oral Posaconazole in Children with leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Acute | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| posaconazole oral suspensions | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- posaconazole as antifungal prophylaxis
- interventionNames
- Drug: posaconazole oral suspensions
Primary outcomes (2)
- measure
- Number, type and grade of adverse events of posaconazole assessed by CTCAE v4.0
- timeFrame
- 1 year
- description
- Number, type and grade of adverse events of posaconazole oral suspensions to children with leukemia assessed by CTCAE v4.0.
- measure
- Plasma posaconazole concentration monitoring and its pharmacokinetic
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 14 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.