UMIN-CTR Clinical Trial

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 Middle name Last name Hiroshi Ishiba
Organization	The North Center of Kyoto prefectural university of medicine
Division name	Gastroenterology and Hepatology
Zip code
Address	481 Otokoyama Yosanocho Yosagun, Kyoto, Japan
TEL	0772-46-3371
Email	chiroinu@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Ishiba
Organization	The North Center of Kyoto prefectural university of medicine
Division name	Gastroenterology and Hepatology
Zip code
Address	481 Otokoyama Yosanocho Yosagun, Kyoto, Japan
TEL	0772-46-3371
Homepage URL
Email	chiroinu@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto prefectural university of medicine
Institute
Department

Funding Source
Organization	none
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	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	Preinitiation
Date of protocol fixation	2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
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	2017 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.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

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