The Establishment of Korean Hepatitis B Patients Cohort
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|ClinicalTrials.gov Identifier: NCT04139850|
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : October 25, 2019
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.
|Condition or disease||Intervention/treatment|
|Chronic Hepatitis B||Drug: Discontinuation of antiviral treatment in chronic hepatitis B cohort patients|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||The Establishment of Korean Hepatitis B Patients Cohort|
|Actual Study Start Date :||September 25, 2015|
|Estimated Primary Completion Date :||August 2026|
|Estimated Study Completion Date :||August 2026|
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
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.
- Development of liver cirrhosis, decompensation or liver cancer [ Time Frame: 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
- Safety and efficacy for patients with or without antiviral therapy [ Time Frame: 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139850
|Contact: Sang Hoon Ahnemail@example.com|
|Korea, Republic of|
|Department of Internal Medicine, Yonsei University College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Sang Hoon Ahn, MD +82-2-2228-1936 firstname.lastname@example.org|