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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001031
Receipt No. R000001226
Scientific Title A long-term prospective cohort study on the natural course and effect of intervention in patients with hepatitis C virus infection.
Date of disclosure of the study information 2008/03/31
Last modified on 2016/08/20

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Basic information
Public title A long-term prospective cohort study on the natural course and effect of intervention in patients with hepatitis C virus infection.
Acronym A prospective cohort study in patients with hepatitis C virus infection.
Scientific Title A long-term prospective cohort study on the natural course and effect of intervention in patients with hepatitis C virus infection.
Scientific Title:Acronym A prospective cohort study in patients with hepatitis C virus infection.
Region
Japan

Condition
Condition Patients with hepatitis C virus infection.
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the natural course and the efficacy and safety of medical intervention in patients with hepatitis C virus infection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Death (liver related or unrelated).
Key secondary outcomes 1. Development of hepatocellular carcinoma.
2. Progression to hepatic decompensation.
3. Progression to cirrhosis.
4. Achievement of sustained virological response.
5. Achievement of sustained biochemical response.
6. Adverse events, dose modification, and discontinuation of therapy.

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 Patients with or with histry of hepatitis C virus infection.
Key exclusion criteria None
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fusao Ikeda
Organization Okayama University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL 086-235-7219
Email yiwasaki@okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiaki Iwasaki
Organization Okayama University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL 086-235-7219
Homepage URL
Email yiwasaki@okayama-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Okayama University Hospital
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
2008 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2001 Year 11 Month 09 Day
Date of IRB
Anticipated trial start date
2001 Year 12 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 Consecutively enrolled, prospective cohort study

Management information
Registered date
2008 Year 02 Month 13 Day
Last modified on
2016 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001226

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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