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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023974
Receipt No. R000027600
Scientific Title Evaluation of relationship between pharmacokinetics and clinical response of voriconazole.
Date of disclosure of the study information 2016/09/08
Last modified on 2016/09/08

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Basic information
Public title Evaluation of relationship between pharmacokinetics and clinical response of voriconazole.
Acronym Evaluation of relationship between pharmacokinetics and clinical response of voriconazole.
Scientific Title Evaluation of relationship between pharmacokinetics and clinical response of voriconazole.
Scientific Title:Acronym Evaluation of relationship between pharmacokinetics and clinical response of voriconazole.
Region
Japan

Condition
Condition immunocompromised or fungal infection
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Infectious disease Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery
Chest surgery Endocrine surgery Obsterics and gynecology
Ophthalmology Dermatology Oto-rhino-laryngology
Urology Oral surgery Neurosurgery
Cardiovascular surgery Plastic surgery Intensive care medicine
Dental medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to investigate the factor of interindividual variability of clinical responses to voriconazole.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The clinical response and plasma concentration of voriconazole at day 5th day or later after the initiation of treatment.
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.Patients receiving voriconazole more than 5 days by orally or intravenously.
2.patients receiving written informed concent.
Key exclusion criteria patients (1) on dialysis; (2) who had hepatopathy (total bilirubin > 2.0 mg/dL); (3) co-treated with rifampicin, ritonavir, carbamazepine, and long-acting barbiturates; and (4) with poor compliance with respect to their medications.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Kawakami
Organization Hamamatsu University School of Medicine
Division name Department of Hospital Pharmacy
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL 053-435-2763
Email pharmacyham-adm@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takafumi Naito
Organization Hamamatsu University School of Medicine
Division name Department of Hospital Pharmacy
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL 053-435-2763
Homepage URL
Email pharmacyham-adm@umin.ac.jp

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

Funding Source
Organization Department of Hospital Pharmacy, Hamamatsu University School of Medicine
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
Address
Tel
Email

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
2016 Year 09 Month 08 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
2016 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The concentrations of voriconazole and N-oxide are measured for pharmacokinetic analysis. Genetic analysis is conducted about the metabolic enzyme related to Voriconazole for metabolic process evaluation. Clinical laboratory values such as total protein, serum albumin, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, blood urea nitrogen, serum creatinine, C-reactive protein, and white blood cell count were ovserved for evaluation of clinical responce druing this study.

Management information
Registered date
2016 Year 09 Month 08 Day
Last modified on
2016 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027600

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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