The Establishment of Korean Hepatitis B Patients Cohort

Chronic Hepatitis B Clinical Trial

Official title:

The Establishment of Korean Hepatitis B Patients Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04139850
• Other study ID #: 4-2015-0748
• Status: Recruiting
• Start date: September 25, 2015
• Est. completion date: August 2026

Study information

• Verified date: October 2019
• Source: Yonsei University
• Contact: Sang Hoon Ahn
• Phone: +82-2-2228-1936
• Email: ahnsh[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of liver cirrhosis, decompensation or liver cancer	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	Time of registration of patient to cohort complement (10 years)
Secondary	Safety and efficacy for patients with or without antiviral therapy	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	Time of registration of patient to cohort complement (10 years)