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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027342
Receipt No. R000031332
Scientific Title Development of hepatocellular carcinoma after hepatitis C virus eradication in interferon-free direct-acting antivirals
Date of disclosure of the study information 2017/05/15
Last modified on 2017/05/15

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Basic information
Public title Development of hepatocellular carcinoma after hepatitis C virus eradication in interferon-free direct-acting antivirals
Acronym Development of hepatocellular carcinoma after direct-acting antivirals
Scientific Title Development of hepatocellular carcinoma after hepatitis C virus eradication in interferon-free direct-acting antivirals
Scientific Title:Acronym Development of hepatocellular carcinoma after direct-acting antivirals
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the risk of HCC among patients with chronic HCV infection, including compensated cirrhosis and previous HCC, following the achievement sustained viral response by DAA treatment.
Basic objectives2 Others
Basic objectives -Others To evaluate the baseline and on-treatment factors associated with HCC development.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rates of the HCC development after DAA treatment.
Key secondary outcomes Factors associated with HCC development.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) chronic hepatitis C patients
Key exclusion criteria (1) under age 20 at the initiation of treatment
(2) decompensated cirrhosis with Child-Pugh B or C
(3) concomitant human immunodeficiency virus or hepatitis B virus infection
(4) excessive active alcohol consumption
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Furusyo
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5909
Email furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiichi Ogawa
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5909
Homepage URL
Email eogawa@gim.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization None
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
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 05 Month 15 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
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 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 This multicenter, observational cohort study analyzed the data of consecutive patients who were enrolled for treatment with an interferon-free DAA regimen for chronic HCV infection from June 2015.

Management information
Registered date
2017 Year 05 Month 15 Day
Last modified on
2017 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031332

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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