The Establishment of Korean Hepatitis B Patients Cohort

NCT04139850 | Recruiting DMC

• 1 other identifier: 4-2015-0748
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Keywords

chronic hepatitis B; cohort; nationwide; prospective; antiviral therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety and efficacy for patients with or without antiviral therapy

  Time of registration of patient to cohort complement (10 years)

Study Arms (1)

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

Drug: Discontinuation of antiviral treatment in chronic hepatitis B cohort patients

Interventions

Discontinuation of antiviral treatment in chronic hepatitis B cohort patients 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.

Korean chronic hepatitis B patients cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient clinic in tertiary hospitals

You may qualify if:

• age above 19 years;
• CHB diagnosis with more than 6 months of HBsAg positive;
• Patients who followed up regularly by medical institutions due to CHB;
• Patients who can be followed up according to the research protocol;
• Patients who have consented to the written consent of the applicant or guardian.

You may not qualify if:

• HCC diagnosis before enrollment;
• Malignant tumor other than HCC within 5 years;
• Hepatitis C virus or human immunodeficiency virus co-infection;
• Fatal conditions such as decompensated liver function, end stage renal disease and severe heart failure;
• not be suitable for the research purpose.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

16cc of whole blood sample in CPT tube

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sang Hoon Ahn

CONTACT

+82-2-2228-1936; ahnsh@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: September 25, 2015
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

KR (1)