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The Establishment of Korean Hepatitis B Patients Cohort

2019年10月23日 更新者：Yonsei University

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (预期的)

2000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Sang Hoon Ahn
  • 电话号码：+82-2-2228-1936
  • 邮箱：ahnsh@yuhs.ac

学习地点

  • 大韩民国
      • Seoul、大韩民国、120-752
        • 招聘中
        • Department of Internal Medicine, Yonsei University College of Medicine
        • 接触：
          • Sang Hoon Ahn, MD
          • 电话号码：+82-2-2228-1936
          • 邮箱：ahnsh@yuhs.ac

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Outpatient clinic in tertiary hospitals

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
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
药品：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Development of liver cirrhosis, decompensation or liver cancer
大体时间：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
Time of registration of patient to cohort complement (10 years)

次要结果测量

结果测量
措施说明
大体时间
Safety and efficacy for patients with or without antiviral therapy
大体时间：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
Time of registration of patient to cohort complement (10 years)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Yonsei University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年9月25日

初级完成 (预期的)

2026年8月1日

研究完成 (预期的)

2026年8月1日

研究注册日期

首次提交

2019年10月23日

首先提交符合 QC 标准的

2019年10月23日

首次发布 (实际的)

2019年10月25日

研究记录更新

最后更新发布 (实际的)

2019年10月25日

上次提交的符合 QC 标准的更新

2019年10月23日

最后验证

2019年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 4-2015-0748

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The patients' clinical and laboratory information are stored in the Korean CDC database as a form of eCRF, then be locked after data cleaning. The sharing data will be coded and won't include patients' sensitive individual information such as a unit-ID and name. The coded data and saved samples will be provided for the guaranteed researchers by the government after confirmation of the relevance of their clinical and basic researches plan related with HBV, during the study and after the study ends.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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