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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Friendship Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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