UMIN-CTR Clinical Trial

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 Yoshiaki Middle name Last name Iwasaki
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
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 Yoshiaki Middle name Last name Iwasaki
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
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	Okayama University
Address	2-5-1, Shikata-cho, Kita-ku, Okayama
Tel	086-235-6938
Email	mae6605@adm.okayama-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	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	2005 Year 09 Month 25 Day
Anticipated trial start date	2001 Year 12 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
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	2020 Year 08 Month 23 Day

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