Elucidation of individual differences in blood concentration of posaconazole in patients with blood diseases and analysis of the relationship with clinical laboratory test values

Elucidation of individual differences in blood concentration of posaconazole in patients with blood diseases and analysis of the relationship with clinical laboratory test values - Elucidation of individual differences in blood concentration of posaconazole in patients with blood diseases and analysis of the relationship with clinical laboratory test values

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045046

Enrollment

120

Registered

2021-08-02

Start date

2021-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood dyscrasia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Persons aged 20 years or older who have been at least 7 days at the same dose since starting PSCZ with the package insert-based dosage (300 mg once on the first day, 300 mg once a day after the second day) .. It also includes patients who have reduced or increased their dose daily if at least 7 days have passed at the same dose. 2) Those who the doctor has determined to be able to participate in this study 3) A person who has obtained consent for this research by signing a consent form by the person or his / her substitute. 4) Those who have obtained consent from the consent form to use the sample or information for research.

Exclusion criteria

Exclusion criteria: 1) Those who the doctor deems inappropriate 2) Those who did not consent to participate in this study 3) Patients with severe liver or renal dysfunction 4) Patients taking azole antifungal drugs other than PSCZ

Design outcomes

Primary

Measure	Time frame
1 Blood concentration (total concentration, free form concentration) of PSCZ and its metabolites, free form fraction 2 Factors that change blood dynamic parameters (clinical test values, diseases, combination drugs, inflammatory markers, hepatic / renal function marker concentrations, pharmacokinetic-related biomarker concentrations) 3 Gene polymorphism of drug-metabolizing enzymes (CYP3A4, CYP3A5, UGT1A), drug transport carriers (ABCB1, OATP1B), blood microRNA concentration 4 Blood concentration of concomitant drugs (tacrolimus, cyclosporine, letermovir) (only when used in combination)	—

Measure

Time frame

1 Blood concentration (total concentration, free form concentration) of PSCZ and its metabolites, free form fraction 2 Factors that change blood dynamic parameters (clinical test values, diseases, combination drugs, inflammatory markers, hepatic / renal function marker concentrations, pharmacokinetic-related biomarker concentrations) 3 Gene polymorphism of drug-metabolizing enzymes (CYP3A4, CYP3A5, UGT1A), drug transport carriers (ABCB1, OATP1B), blood microRNA concentration 4 Blood concentration of concomitant drugs (tacrolimus, cyclosporine, letermovir) (only when used in combination)

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Countries

Japan

Contacts

Public ContactYumi Imoto

Hamamatsu University School of Medicine Department of Hospital Pharmacy

yimoto@hama-med.ac.jp0534352763

Outcome results