The Establishment of Korean Hepatitis B Patients Cohort

NCT ID: NCT04139850

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-25
• Study Completion Date: 2026-08-31

Brief 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 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 more than 2,000 cases per year with 6 months of regular follow-up interval as have been advised by the CDC during 10 years of the study period (from Sep. 2015) from 5 tertiary hospitals located in Korea. The investigators plan to register available cases from those who are available to agree to give written informed consent and provide their blood samples to participate in this study prospectively, according to the inclusion and exclusion criteria.

Conditions

Chronic Hepatitis B

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Korean chronic hepatitis B patients cohort

Korean patients with chronic hepatitis B with or without antiviral therapy on a regular follow-up in tertially medical institution

Discontinuation of antiviral treatment in chronic hepatitis B cohort patients

Intervention Type: DRUG

For the selective patients in the cohort with long-term antiviral therapy and with conditions such as HBeAg negative or loss more than one year, antiviral therapy is able to be discontinued with an intensive inspection who agreed to the process. If there are need of this intervention, another multicenter IRB approval will be taken.

Interventions

Discontinuation of antiviral treatment in chronic hepatitis B cohort patients

For the selective patients in the cohort with long-term antiviral therapy and with conditions such as HBeAg negative or loss more than one year, antiviral therapy is able to be discontinued with an intensive inspection who agreed to the process. If there are need of this intervention, another multicenter IRB approval will be taken.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. age above 19 years;

2. CHB diagnosis with more than 6 months of HBsAg positive;

3. Patients who followed up regularly by medical institutions due to CHB;

4. Patients who can be followed up according to the research protocol;

5. Patients who have consented to the written consent of the applicant or guardian.

Exclusion Criteria

1. HCC diagnosis before enrollment;

2. Malignant tumor other than HCC within 5 years;

3. Hepatitis C virus or human immunodeficiency virus co-infection;

4. Fatal conditions such as decompensated liver function, end stage renal disease and severe heart failure;

5. not be suitable for the research purpose.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Internal Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sang Hoon Ahn

Role: CONTACT

ahnsh@yuhs.ac

+82-2-2228-1936

Facility Contacts

Sang Hoon Ahn, MD

Role: primary

ahnsh@yuhs.ac

+82-2-2228-1936

Other Identifiers

4-2015-0748

Identifier Type: -

Identifier Source: org_study_id