The Establishment of Korean Hepatitis B Patients Cohort

Recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Discontinuation of antiviral treatment in chronic hepatitis B cohort patients

• Registration Number: NCT04139850
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-25
• Status Verified: 2019-10
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Last Update Submitted: 2019-10-23
• Study First Posted: 2019-10-25
• Last Update Posted: 2019-10-25
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Korean chronic hepatitis B patients cohort	Discontinuation of antiviral treatment in chronic hepatitis B cohort patients	Korean patients with chronic hepatitis B with or without antiviral therapy on a regular follow-up in tertially medical institution

Primary Outcome Measures

Name	Time	Method
Development of liver cirrhosis, decompensation or liver cancer	Time of registration of patient to cohort complement (10 years)	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.) Safety issue: No

Secondary Outcome Measures

Name	Time	Method
Safety and efficacy for patients with or without antiviral therapy	Time of registration of patient to cohort complement (10 years)	Virologic response, HBsAg loss or seroconversion, development of resistance to medication, side effect with or without antiviral therapy Virologic breakthrough/development of liver cirrhosis, decompensation or HCC after discontinuation of antiviral therapy

Trial Locations

Locations (1)

Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of