UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of individual differences in blood concentration of posaconazole in patients with blood diseases and analysis of the relationship with clinical laboratory test values
Acronym	Elucidation of individual differences in blood concentration of posaconazole in patients with blood diseases and analysis of the relationship with clinical laboratory test values
Scientific Title	Elucidation of individual differences in blood concentration of posaconazole in patients with blood diseases and analysis of the relationship with clinical laboratory test values
Scientific Title:Acronym	Elucidation of individual differences in blood concentration of posaconazole in patients with blood diseases and analysis of the relationship with clinical laboratory test values
Region	Japan

Condition
Condition	Blood dyscrasia
Classification by specialty	Medicine in general Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Evaluate blood posaconazole(PSCZ) and its metabolite concentration in patients with blood diseases, analyze individual differences in blood PSCZ concentration based on information such as concomitant drugs and pharmacokinetic-related biomarkers, and analyze blood PSCZ concentration. Establish a prediction method for. In addition to the above studies, the effect of PSCZ blood concentration itself on various laboratory test values will be evaluated in detail.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Junichi Middle name Last name Kawakami
Organization	Hamamatsu University School of Medicine
Division name	Department of Hospital Pharmacy
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL	0534352763
Email	kawakami-ham@umin.ac.jp

Public contact
Name of contact person	1st name Yumi Middle name Last name Imoto
Organization	Hamamatsu University School of Medicine
Division name	Department of Hospital Pharmacy
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL	0534352763
Homepage URL
Email	yimoto@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine Department of Hospital Pharmacy
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine Department of Hospital Pharmacy
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine Clinical Research Committee
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
Tel	0534352680
Email	rinri@hama-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2021 Year 07 Month 06 Day
Date of IRB	2021 Year 07 Month 06 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2026 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Items to collect as data Background of study subjects age, gender, medical history, complications, presence or absence of allergies, family history, life history, medication status Physical findings height, weight, blood pressure, pulse, body temperature Laboratory tests hematological tests (eg white blood cell count, hemoglobin level, platelet count, neutrophil count, etc.), biochemical tests (eg: Bil, AST, ALT, GTP, ALP, Alb, BUN, Cre, eGFR, CRP, total cholesterol, IL-6, etc.) Others PSCZ and its metabolite concentration (total concentration, free form concentration), cystatin C, pharmacokinetic biomarkers (4B cholesterol hydroxide, coproporphyrin, 25 hydroxide vitamin D), cytochrome P450 enzyme, UDP glucuronosyl transfer Enzyme, P-sugar protein and organic anion transporter genotype, microRNA concentration, blood concentration of concomitant drug Adverse events Presence or absence of fungal infection

Management information
Registered date	2021 Year 08 Month 02 Day
Last modified on	2021 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051453