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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024420
Receipt No. R000028096
Scientific Title Impact of genetic polymorphism in patients with chronic hepatitis B
Date of disclosure of the study information 2016/10/15
Last modified on 2019/08/02

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Basic information
Public title Impact of genetic polymorphism in patients with chronic hepatitis B
Acronym Impact of genetic polymorphism in patients with chronic hepatitis B
Scientific Title Impact of genetic polymorphism in patients with chronic hepatitis B
Scientific Title:Acronym Impact of genetic polymorphism in patients with chronic hepatitis B
Region
Japan

Condition
Condition chronic hepatitis B
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 elucidate the relation between genetic polymorphism and progression of chronic hepatitis B
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)elucidate the relation between IL28B polymorphism and chronic hepatitis B
2)elucidate the relation between HLA polymorphism and chronic hepatitis B
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 patients with positive HBs antigen or patients with positive HBs antibody and/or HBc antibody
Key exclusion criteria patients disqualified by principal investigator
Target sample size 500

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 The department of Gastroenterology and Hepatology
Zip code 565-0871
Address 2-2 Yamadaooka Suita Osaka
TEL 0668793621
Email takehara@gh.md.osaka-u.ac.jp

Public contact
Name of contact person
1st name Ryoko
Middle name
Last name Yamada
Organization Osaka University Graduate School of Medicine
Division name The department of Gastroenterology and Hepatology
Zip code 565-0871
Address 2-2 Yamadaooka Suita Osaka
TEL 0668793621
Homepage URL
Email ryo726@gh.md.osaka-u.ac.jp

Sponsor
Institute The department of Gastroenterology and Hepatology Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka University Clinical Research Review Committee
Address 2-2, Yamadaoka, Suita, Osaka
Tel 06-6210-8289
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
2016 Year 10 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information starting observation study about patients who provide consent

Management information
Registered date
2016 Year 10 Month 15 Day
Last modified on
2019 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028096

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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