Clinical trial · Observational
Voriconazole Trough Plasma Levels : Genetic Polymorphism, Efficacy, Safety in Patients With Hematologic Malignancy
The Correlation of Voriconazole Trough Plasma Levels With Genetic Polymorphism, Efficacy, and Safety Outcomes in Hematologic Malignancy Patients With Invasive Pulmonary Aspergillosis
- 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)
Multiple factors are associated with a large variability in voriconazole exposure following standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug interactions, liver disease, patient age, and genetic polymorphism of the metabolic enzymes. Voriconazole is extensively metabolized by the human hepatic enzymes, primarily mediated by CYP2C19. The polymorphisms account for a relatively large portion of inter-individual variance observed in voriconazole plasma concentrations. However, there are limited data on the relationships between voriconazole blood levels and clinical outcomes or safety in Asian populations. The purpose of this study is to investigate the relationships of voriconazole blood levels with genetic polymorphism, safety, and clinical outcomes in immunocompromised patients with invasive pulmonary aspergillosis.
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 |
|---|---|---|---|
| Invasive Fungal Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| voriconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Patients with hematologic malignancies who were given voriconazole to treat invasive (pulmonary) aspergillosis at Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
- interventionNames
- Drug: voriconazole
Primary outcomes (1)
- measure
- Successful outcome at 12 weeks after voriconazole use
- timeFrame
- 12 weeks
- description
- Successful outcome = complete response + partial response Unsuccessful outcome = stable disease + failure of therapy + indeterminate response
Secondary outcomes (5)
- measure
- IFI (invasive fungal infection)-related mortality at 12 weeks
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: all items below * male or female ≥ 15 years of age * immunocompromised patients with hematologic disorders * patients received voriconazole due to treat proven, probable invasive (pulmonary) aspergillosis Exclusion Criteria: * severe hepatic dysfunction (t.bil, AST, ALT, ALP \> 5 x upper normal limit) * who experienced hypersensitivity to azoles * pregnant women
References
Publications (0)
Data not yet available