A Nation-wide Hospital-based Hepatitis B Registry:China Registry of Hepatitis B

November 2, 2017 updated by: Jidong Jia, Beijing Friendship Hospital
CR-HepB registry started in June 30,2012 to collect HBV cases from general hospitals or specialized hospitals for infectious diseases in mainland China. Demographics, diagnosis, laboratory test results, family history and prescriptions were recorded. The main criteria for registration is HBsAg-positivity more than 6 months, and these patients will receive followed-up visits every three to six months.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This web-based database was launched on June 30, 2012 and consists of tertiary or secondary hospitals with special interest and expertise on managing hepatitis B patients across mainland China. The main inclusion criteria for this registration are HBsAg-positivity ≥ 6 months, HBeAg positive or negative, with or without cirrhosis, either treatment-naïve or treatment experienced. At the first time of data entry, demographics, medical history, virology, biochemistry and hematology results, radiology reports, diagnosis and treatment information were recorded. Then the registered patients received standard of care and follow-up every 3 to 6 months. On each visit, virological, biochemical, and radiological reports, as well as clinical progress were recorded.

Study Type

Observational

Enrollment (Anticipated)

200000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing, China, 100050
      • Beijing, Beijing, China, 100015
      • Beijing, Beijing, China, 100069
    • Chongqing
      • Chongqing, Chongqing, China, 400010
      • Chongqing, Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Recruiting
        • Lanzhou University Second Hospital
        • Contact:
      • Lanzhou, Gansu, China, 730099
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
      • Guiyang, Guizhou, China
        • Recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570311
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The second hospital of Hebei Medical University
        • Contact:
      • Shijiazhuang, Hebei, China, 050051
        • Recruiting
        • The third hospital of Hebei medical university
        • Contact:
      • Shijiazhuang, Hebei, China, 050021
        • Recruiting
        • The Fifth Hospital of Shijiazhuang
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
      • Changsha, Hunan, China, 410005
        • Recruiting
        • Hunan Provincial People's Hospital
        • Contact:
    • Inner Mongolia
      • Wuhai, Inner Mongolia, China, 016099
        • Recruiting
        • Infectious Disease Hospital of Wuhai
        • Contact:
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221006
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • First Hospital of Jilin University
        • Contact:
      • Yanbian, Jilin, China, 133000
        • Recruiting
        • The Affiliated Hospital of Yanbian University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital of China Medical University
    • Ningxia
      • Yinchuan, Ningxia, China, 70004
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250033
        • Recruiting
        • The Second Hospital of Shandong University
        • Contact:
      • Weifang, Shandong, China, 261031
        • Recruiting
        • Affiliated hospital of Weifang Medical University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 201508
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Shanghai Ruijin Hospital
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • The First Affiliated Hospital of Shanxi Medical University
        • Contact:
      • Taiyuan, Shanxi, China, 030012
        • Recruiting
        • Taiyuan No.3 Hospital
        • Contact:
      • Xi'an, Shanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Yanan, Shanxi, China, 716000
        • Recruiting
        • Yanan University Affiliated Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
      • Luzhou, Sichuan, China, 646099
        • Recruiting
        • The Affiliated Hospital of Southwest Medical University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300163
        • Recruiting
        • Affiliated Hospital, Logistics University of People's Armed Police Force
        • Contact:
      • Tianjin, Tianjin, China, 610041
        • Recruiting
        • Tianjin Third Central Hospital
        • Contact:
    • Xinjiang
      • Changji, Xinjiang, China, 831118
        • Recruiting
        • People's Hospital of Changji Hui Autonomous Prefecture，Xinjiang
        • Contact:
      • Urumqi, Xinjiang, China, 830099
        • Recruiting
        • Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
        • Contact:
      • Urumqi, Xinjiang, China, 830054
        • Recruiting
        • First Affiliated Hospital of Xinjiang Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310023

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The registry is a multicentre and observational study enrolling patients with hepatitis B across China. The main criteria for patients registration within the system was HBsAg-positivity over a continuous six months. The core exclusion criteria are: 1) HCC patients for their treatment mainly depends on surgical operation and interventional therapy, but not the antiviral therapy; 2) patients who are unable or unwilling to provide informed consent. All potential subjects meeting enrollment criteria are offered the opportunity to participate.

Description

Inclusion Criteria:

  • HBsAg-positivity over a continuous six months.

The core exclusion criteria are: 1) HCC patients for their treatment mainly depends on surgical operation and interventional therapy, but not the antiviral therapy; 2) patients who are unable or unwilling to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Immune tolerance phase
Immune tolerance phase is diagnosed based on the presence of high serum levels of HBV-DNA, hepatitis B e antigen (HBeAg), but normal or minimally elevated serum alanine aminotransferase (ALT), and normal liver or only minimal histological activity and scant fibrosis.
HBeAg positive CHB
HBeAg positive CHB is defined as those with HBsAg positive for more 6 months, HBeAg positive, high HBV DNA, elevated serum levels of ALT and histological activity.
HBeAg negative CHB
HBeAg negative CHB is defined as those with HBeAg negative, anti-HBe positive, lower serum HBV DNA levels and histological necroinflammation and fibrosis.
Inactive HBsAg carriers
Inactive HBsAg carriers was defined as those with HBsAg positive than 6 months, with low HBV DNA and persistently normal ALT, without evidence of cirrhosis.
Compensated cirrhosis

Diagnosis of compensated cirrhosis can be made if one of the following criteria was met:

  1. by liver histology: Ishak fibrosis stage 5-6 or METAVIR F4.
  2. endoscopy-proven gastroesophageal varices, afrter excluding non-cirrhotic portal hypertension.

  3. at least 2 features of cirrhosis:

    1. irregular liver surface, granular or nodular liver parenchyma, with or without splenomegaly (spleen thickness > 4.0cm or > 5 rib units) on ultrasound ,CT or MRI;
    2. PLT<100×109/L without other causes;
    3. Serum album in<35 g/L or INR>1.3 or PT prolongs>3s;
    4. LSM>13 kpa (ALT<5×ULN).
Decompensated cirrhosis
Decompensated cirrhosis was diagnosed based on the presence of ascites, bleeding esophageal varices and/or hepatic encephalopathy in cirrhotic patients.
Hepatocellular carcinoma
Diagnosis of hepatocellular carcinoma（HCC）can be established when one of the following one of the following 2 criteria:（1）in cirrhotic patients with nodules of 1cm or larger with typical features of HCC ( arterial enhancement with washout in venous or delay phase) on 2 radiological studies or with 1 radiological study and elevation of serum AFP; or（2）histological evidence of HCC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of liver-related events after antiviral therapy
Time Frame: 10 years
Rates of cirrhosis,decompensation and hepatocellular carcinoma with or without antiviral therapy
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The HBV DNA undetectable rate with or without antiviral therapy
Time Frame: 10 years
10 years
HBeAg loss and seroconversion rates with or without antiviral therapy
Time Frame: 10 years
10 years

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 10 years
10 years
HBsAg loss and seroconversion rates with or without antiviral therapy
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Collaborators

Peking University First Hospital
Xiangya Hospital of Central South University
Wuhan University
LanZhou University
Peking University People's Hospital
Beijing YouAn Hospital
Beijing Ditan Hospital
Peking Union Medical College Hospital
Beijing Tiantan Hospital
The Second Hospital of Hebei Medical University
West China Hospital
Shengjing Hospital
First Affiliated Hospital Xi'an Jiaotong University
Nanfang Hospital of Southern Medical University
Ruijin Hospital
Guizhou Provincial People's Hospital
The First Hospital of Jilin University
Henan Provincial People's Hospital
Hunan Provincial People's Hospital
Shanghai Public Health Clinical Center
The Second Affiliated Hospital of Chongqing Medical University
The Affiliated Hospital Of Guizhou Medical University
The First Affiliated Hospital of Kunming Medical College
Hainan General Hospital
General Hospital of Ningxia Medical University
The Second Hospital of Shandong University
Tianjin Third Central Hospital
The First Affiliated Hospital of Shanxi Medical University
First Affiliated Hospital of Xinjiang Medical University
Hebei Medical University Third Hospital
First Affiliated Hospital of Chongqing Medical University
The Affiliated Hospital of Xuzhou Medical University
The Affiliated Hospital Of Southwest Medical University
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
Logistics University of Chinese People's Armed Police Forces
Yan'an University Affiliated Hospital
Fifth Hospital of Shijiazhuang City
The Affiliated Hospital of Yanbian University
Weifang Medical University
The Third People's Hospital of Taiyuan
The Fouth Hospital of Qinghai province
Xixi Hospital of Hangzhou
Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology
Infectious Disease Hospital of Wuhai
People's Hospital of Changji Hui Autonomous Prefecture，Xinjiang

Investigators

  • Principal Investigator: Jidong Jia, Doctor, Beijing Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2012

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-HepB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Hepatitis B

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe