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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014300
Receipt No. R000016653
Scientific Title Assessment of hepatitis C virus prior to anti-viral therapy
Date of disclosure of the study information 2014/06/18
Last modified on 2021/04/23

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Basic information
Public title Assessment of hepatitis C virus prior to anti-viral therapy
Acronym Assessment of HCV
Scientific Title Assessment of hepatitis C virus prior to anti-viral therapy
Scientific Title:Acronym Assessment of HCV
Region
Japan

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

Objectives
Narrative objectives1 Assessment of drug tolerance of hepatitis C virus prior to antiviral therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes distribution of hepatitis C virus with drug tolerance
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria chronic hepatitis C
Key exclusion criteria none
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fusao Ikeda
Organization Okayama University Hospital
Division name Gastroenterology
Zip code
Address 2-1-5 Shikatacho, Kitaku, Okayama
TEL 086-235-7219
Email fikeda@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fusao Ikeda
Organization Okayama University Hospital
Division name Gastroenterology
Zip code
Address 2-5-1 Shikatacho, Kitaku, Okayama
TEL 086-235-7219
Homepage URL
Email fikeda@md.okayama-u.ac.jp

Sponsor
Institute Department of Gastroenterology, Okayama University Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology, Okayama University Hospital
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
2014 Year 06 Month 18 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 Completed
Date of protocol fixation
2014 Year 05 Month 27 Day
Date of IRB
2014 Year 05 Month 20 Day
Anticipated trial start date
2014 Year 06 Month 18 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information to assess the distribution of drug tolerant hepatitis C virus

Management information
Registered date
2014 Year 06 Month 18 Day
Last modified on
2021 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016653

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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