The Establishment of Korean Hepatitis B Patients Cohort

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Development of liver cirrhosis, decompensation or liver cancer [Срок оценки: Time of registration of patient to cohort complement (10 years)]

Вторичные конечные точки (1)

• Safety and efficacy for patients with or without antiviral therapy [Срок оценки: Time of registration of patient to cohort complement (10 years)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Department of Internal Medicine, Yonsei University College of Medicine — Seoul

Идентификаторы

NCT: NCT04139850 · 4-2015-0748

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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