UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032781 |
|---|---|
| Receipt number | R000037396 |
| Scientific Title | Analysis of the effect of OATP1B3 genomic abnormality on hepatic ICG clearance |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/06/01 09:10:24 |
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Basic information
Public title
Analysis of the effect of OATP1B3 genomic abnormality on hepatic ICG clearance
Acronym
Analysis of the effect of OATP1B3 genomic abnormality on hepatic ICG clearance
Scientific Title
Analysis of the effect of OATP1B3 genomic abnormality on hepatic ICG clearance
Scientific Title:Acronym
Analysis of the effect of OATP1B3 genomic abnormality on hepatic ICG clearance
Region
| Japan |
Condition
Condition
chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the relationship between SLCO1B3 variant and ICG clearance
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
ICG clearance rate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic hepatitis C whose SLCO1B3 genotype was known.
Key exclusion criteria
NA
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | Tatehiro |
| Middle name | |
| Last name | Kagawa |
Organization
Tokai University School of Medicine
Division name
Hepatology and Gastroenterology
Zip code
259-1193
Address
Isehara
TEL
0463-93-1121
kagawa@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Tatehiro |
| Middle name | |
| Last name | Kagawa |
Organization
Tokai University School of Medicine
Division name
Hepatology and Gastroenterology
Zip code
259-1193
Address
Isehara
TEL
0463-93-1121
Homepage URL
kagawa@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai University
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
Tokai University
Address
Isehara
Tel
0463931121
kagawa@tokai.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
| 2018 | Year | 06 | Month | 01 | 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
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2021 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037396
