UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045046 |
|---|---|
| Receipt number | R000051453 |
| 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 |
| Date of disclosure of the study information | 2021/08/02 |
| Last modified on | 2021/08/02 20:43:08 |
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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
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
yimoto@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine Department of Hospital Pharmacy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051453
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