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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036150
Receipt No. R000040761
Scientific Title Multicenter study of outcome of liver cirrhotic patients received HCV elimination therapy
Date of disclosure of the study information 2019/03/11
Last modified on 2019/03/11

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Basic information
Public title Multicenter study of outcome of liver cirrhotic patients received HCV elimination therapy
Acronym Multicenter study of outcome of liver cirrhotic patients received HCV elimination therapy
Scientific Title Multicenter study of outcome of liver cirrhotic patients received HCV elimination therapy
Scientific Title:Acronym Multicenter study of outcome of liver cirrhotic patients received HCV elimination therapy
Region
Japan

Condition
Condition hepatitis C virus associated liver cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the treatment effect of antiviral therapy and the effect of improvement of disease condition in hepatitis C virus associated liver cirrhotic patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sustained virologic response rate and factors associated with it
Key secondary outcomes Cumulative HCC occurrence rate and factors associated with it.
Change of Child-pugh score and MELD score and factors associated with these.
Cumulative survival rate, all cause mortality and liver disease related mortality and factors associated with these.
safety

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 HCV associated liver cirrhotic patients who were started DAA therapy between February 1 2019 and December 31 2021.
Key exclusion criteria Patients who were judged inadequate to participate by researchers.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Takehara
Organization Osaka university graduate school of medicine
Division name Gastroenterology and Hepatology
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Hayato
Middle name
Last name Hikita
Organization Osaka university graduate school of medicine
Division name Gastroenterology and Hepatology
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3621
Homepage URL
Email hikita@gh.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology Osaka university graduate school of medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka Univercity Clinical Research Review Committee
Address 2-2 Yamadaoka, Suita, Osaka
Tel 06-6210-8296
Email rinri@hp-crc.med.osaka-u.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
2019 Year 03 Month 11 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 24 Day
Date of IRB
2019 Year 03 Month 05 Day
Anticipated trial start date
2019 Year 03 Month 05 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2019 Year 03 Month 11 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040761

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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