UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020279
Receipt number R000019337
Scientific Title Investigation for relationships between host or viral factors and pathological or therapeutic outcome as viral hepatitis.
Date of disclosure of the study information 2015/12/19
Last modified on 2020/06/23 12:07:14

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Basic information

Public title

Investigation for relationships between host or viral factors and pathological or therapeutic outcome as viral hepatitis.

Acronym

Investigation for relationships between host or viral factors and pathological or therapeutic outcome as viral hepatitis.

Scientific Title

Investigation for relationships between host or viral factors and pathological or therapeutic outcome as viral hepatitis.

Scientific Title:Acronym

Investigation for relationships between host or viral factors and pathological or therapeutic outcome as viral hepatitis.

Region

Japan


Condition

Condition

Viral hepatitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To investigate relationships between host or viral factors and pathological or therapeutic outcomes as viral hepatitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Outcomes of viral response, viral genome sequence, NRF2 expression, number of hepatic progenitor cells in the liver specimens, or any other datas which we can obtain by daily medical practice containing age, sex, history of patients who had treatments for viral hepatitis at 24 weeks after end 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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients who are diagnosed as viral hepatitis
2.Patients who agree with this research by documents
3.Patients who is judged totally appropriate by doctors responsible for this research, in addition to above two conditions.

Key exclusion criteria

1.Patients who doesn't agree with this research by documents.
2.Patients who is judged totally inappropriate by lead principal investigator.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yoshimasa
Middle name
Last name Kobayashi

Organization

Hamamatsu University School of Medicine

Division name

Department of Liver Diseases

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan

TEL

053-435-2263

Email

yoshi@hama-med.ac.jp


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Chida

Organization

Hamamatsu University School of Medicine

Division name

Department of Liver Diseases

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan

TEL

053-435-2263

Homepage URL


Email

tchida@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Higasi-ku, Hamamatsu, Shizuoka, Japan

Tel

053-435-2263

Email

tchida0731@gmail.com


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

磐田市立総合病院(静岡県)、済生会兵庫県病院(兵庫県)、市立御前崎総合病院(静岡県)、市立島田市民病院(静岡県)、聖隷浜松病院(静岡)、聖隷三方原病院(静岡県)浜松医療センター(静岡県)、浜松赤十字病院(静岡県)、静岡市立静岡病院(静岡県)、焼津市立総合病院(静岡県)、浜松北病院(静岡県)、浜松市引佐伊平診療所(静岡県)、二川病院(愛知県)、エルム内科クリニック(静岡県)、たまこしクリニック(静岡県)、つがね消化器科内科医院(静岡県)、中島内科消化器科医院(静岡県)、中村医院(静岡県)、みのる内科クリニック(静岡県)、西脇医院(静岡県)


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 19 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

2014 Year 07 Month 31 Day

Date of IRB

2019 Year 06 Month 27 Day

Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2024 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observe blood chemistry, metabolomics, viral mutation profiles at the point of pre-treatment, post-treatment(after 2,4,6,8,10,12,16,20,24 weeks), and 4,12,24 weeks after end of treatment.


Management information

Registered date

2015 Year 12 Month 19 Day

Last modified on

2020 Year 06 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019337


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name