UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027801
Receipt number R000031854
Scientific Title The prognosis of older patients treated about the chronic hepatitis C in the North area of Kyoto, Japan
Date of disclosure of the study information 2017/07/01
Last modified on 2021/03/23 22:42:15

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Basic information

Public title

The prognosis of older patients treated about the chronic hepatitis C in the North area of Kyoto, Japan

Acronym

The prognosis of older HCV patients in the North area of Kyoto, Japan

Scientific Title

The prognosis of older patients treated about the chronic hepatitis C in the North area of Kyoto, Japan

Scientific Title:Acronym

The prognosis of older HCV patients in the North area of Kyoto, Japan

Region

Japan


Condition

Condition

Chronic Hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to be clear the carcinogenesis of HCC, the background, the change of liver function, the direct cause of death of the older patients after treated the chronic hepatitis C.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cumulative carcinogenic rate

Key secondary outcomes

SVR rate, the Over all survival, Recurrence rate, the transition of liver function, liver fibrosis, The event related liver disease and cardiovascular disease.


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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The objects are 65 years or higher patients treated the chronic hepatitis C in our hospital.

Key exclusion criteria

none

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Ishiba

Organization

Kyoto prefectural university of medicine

Division name

Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kajiicho, Kawaramachitorihirokojiagaru, Kamigyoku, Kyoto, Japan

TEL

075-251-5519

Email

chiroinu@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Ishiba

Organization

Kyoto prefectural university of medicine

Division name

Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kajiicho, Kawaramachitorihirokojiagaru, Kamigyoku, Kyoto, Japan

TEL

075-251-5519

Homepage URL


Email

chiroinu@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto prefectural university of medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto prefectural university 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

Kyoto prefectural university of medicine IRB

Address

465 Kajiicho, Kawaramachitorihirokojiagaru, Kamigyoku, Kyoto, Japan

Tel

075-251-5872

Email

m-muramatsu76@pref.kyoto.lg.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

2017 Year 07 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

2017 Year 04 Month 01 Day

Date of IRB

2017 Year 08 Month 29 Day

Anticipated trial start date

2017 Year 08 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

The objects are the 65 years or higher patients who treated the chronic hepatitis C from April 2014. The observation period is 12 years until March 2026.


Management information

Registered date

2017 Year 06 Month 18 Day

Last modified on

2021 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031854


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name