Establishment of Retrospective and Prospective Multicenter Cohort for Chronic Hepatitis B

January 23, 2017 updated by: Yonsei University

According to the World Health Organization about 1,400,000 deaths reported annually, are related to chronic liver disease. Chronic liver disease is very prevalent in South Korea, placing a large economic burden nationwide. Subsequently, an effective and systematized approach to managing chronic hepatitis is imperative in Korea.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

outpatient clinic in tertiary hospital

Description

Inclusion Criteria:

  1. Subject aged 20 years or older
  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:

  1. Subject with decompensated liver cirrhosis or hepatocellular carcinoma at the time of initial liver fibroscan
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
chronic hepatitis B subjects
Subjects who have been diagnosed with chronic hepatitis B.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
retrospective and prospective multicenter cohort for chronic hepatitis B based on Korean patients
Time Frame: time of registration of patient to cohort completment
This study aims for the establishment of chronic hepatitis B cohort and has no other primary end point other than the registration of the patient. (For Time-to-Event outcome measures, the development of events including HCC, ascitic decompensation, variceal bleeding, hepatic encephalopathy, transplantation, and death will be followed up to 10 years after enrollment. Time to the development of each kind of event will be calculated from the date of enrollment and the respective date of event development.)
time of registration of patient to cohort completment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Kwang Hyub Han, MD,PhD, Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2014

Primary Completion (Actual)

June 25, 2015

Study Completion (Actual)

June 25, 2015

Study Registration Dates

First Submitted

September 3, 2014

First Submitted That Met QC Criteria

October 7, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0582

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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