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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name