UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023974 |
|---|---|
| Receipt number | 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 00:07:16 |
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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 | Obstetrics 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
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
pharmacyham-adm@umin.ac.jp
Sponsor or person
Institute
Department of Hospital Pharmacy, Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027600
