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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032781
Receipt No. 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 2018/05/30

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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
Middle name
Last name Tatehiro Kagawa
Organization Tokai University School of Medicine
Division name Hepatology and Gastroenterology
Zip code
Address Isehara
TEL 0463-93-1121
Email kagawa@tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatehiro Kagawa
Organization Tokai University School of Medicine
Division name Hepatology and Gastroenterology
Zip code
Address Isehara
TEL 0463-93-1121
Homepage URL
Email kagawa@tokai.ac.jp

Sponsor
Institute Tokai University
Institute
Department

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
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
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
2018 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037396

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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