NCT02263755

Establishment of Retrospective and Prospective Multicenter Cohort for Chronic Hepatitis B

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 476 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Hepatitis B

Timeline

• Start date: 2014-09-02
• Primary completion: 2015-06-25
• Completion: 2015-06-25
• First posted: 2014-10-13
• Last updated: 2017-01-25