Establishment of Retrospective and Prospective Multicenter Cohort for Chronic Hepatitis B
NCT ID: NCT02263755
Last Updated: 2017-01-25
Study Results
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Basic Information
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COMPLETED
476 participants
OBSERVATIONAL
2014-09-02
2015-06-25
Brief Summary
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The natural history of chronic liver disease differs greatly according to race and ethnicity. However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients. Therefore, the investigators plan to establish a retrospective and prospective multicenter cohort for chronic hepatitis B based on Korean patients that may be utilized for various future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the establishment and distribution of clinical guidelines for Korean patients with chronic hepatitis B, as part of a nationwide project supported by the Centers for Disease Control (CDC), Korea.
The investigators plan to collect 500 cases as have been advised by the CDC during the study period (September, 2014-March, 2015) from 4 tertiary hospitals located in Korea. In the past 5 years, there have been about 800 subjects with chronic hepatitis B who have undergone liver fibroscan and liver biopsy from these 4 institutions. The investigators plan to register available cases retrospectively from those who are available to agree to give written informed consent to participate in this study, and to register the remaining numbers of cases prospectively, according to the inclusion and exclusion criteria.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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chronic hepatitis B subjects
Subjects who have been diagnosed with chronic hepatitis B.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Subject who has been diagnosed with chronic hepatitis B (HBs Ag (+) for minimum of 6 months\_
3. Subject who is currently under clinical follow up at the registered institution
4. Subject who has undergone or who can undergo liver fibroscan at the time of registration
5. Subject who has given informed consent to the enrollment
Exclusion Criteria
2. Subject who had previously undergone antiviral therapy for chronic hepatitis B
3. Subject who are concomittantly infected with HCV, HDV or HIV
4. Subject with chronic alcoholism defined as equal to or greater than 40g of alcohol for duration of 5 years or longer
5. Subject who has been diagnosed with right sided heart failure
6. Subjects whose liver fibroscan result is not valid
7. Subject who is considered ineligible to the enrollment to clinical study by the researcher
8. Subjects who is pregnant at the time of registration
9. Pregnancy
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Kwang Hyub Han, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Yonsei University
References
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Jung KS, Kim SU, Ahn SH, Park YN, Kim DY, Park JY, Chon CY, Choi EH, Han KH. Risk assessment of hepatitis B virus-related hepatocellular carcinoma development using liver stiffness measurement (FibroScan). Hepatology. 2011 Mar;53(3):885-94. doi: 10.1002/hep.24121. Epub 2011 Feb 11.
Kim SU, Ahn SH, Park JY, Kang W, Kim DY, Park YN, Chon CY, Han KH. Liver stiffness measurement in combination with noninvasive markers for the improved diagnosis of B-viral liver cirrhosis. J Clin Gastroenterol. 2009 Mar;43(3):267-71. doi: 10.1097/MCG.0b013e31816f212e.
Kim SU, Seo YS, Cheong JY, Kim MY, Kim JK, Um SH, Cho SW, Paik SK, Lee KS, Han KH, Ahn SH. Factors that affect the diagnostic accuracy of liver fibrosis measurement by Fibroscan in patients with chronic hepatitis B. Aliment Pharmacol Ther. 2010 Aug;32(3):498-505. doi: 10.1111/j.1365-2036.2010.04353.x. Epub 2010 May 11.
Other Identifiers
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4-2014-0582
Identifier Type: -
Identifier Source: org_study_id
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