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

NCT03108794 | Unknown

• 1 other identifier: CR-HepB
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 45

Brief Summary

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.

Conditions

Chronic Hepatitis B

Keywords

hepatitis B，registry,cirrhosis, HCC

Outcome Measures

Primary Outcomes (1)

• Rate of liver-related events after antiviral therapy

  Rates of cirrhosis,decompensation and hepatocellular carcinoma with or without antiviral therapy

  10 years

Secondary Outcomes (2)

• The HBV DNA undetectable rate with or without antiviral therapy

  10 years

• HBeAg loss and seroconversion rates with or without antiviral therapy

  10 years

Other Outcomes (2)

• HBsAg loss and seroconversion rates with or without antiviral therapy

  10 years

• Quality of life

  10 years

Study Arms (7)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• HBsAg-positivity over a continuous six months.

Sponsors & Collaborators

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

Study Sites (45)

Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Beijing Youan Hospital

Beijing, Beijing Municipality, 100069, China

RECRUITING

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730099, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

RECRUITING

Guizhou provincial people's hospital

Guiyang, Guizhou, China

RECRUITING

Hainan General Hospital

Haikou, Hainan, 570311, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

The Fifth Hospital of Shijiazhuang

Shijiazhuang, Hebei, 050021, China

RECRUITING

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, 410005, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

RECRUITING

Infectious Disease Hospital of Wuhai

Wuhai, Inner Mongolia, 016099, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

RECRUITING

First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

The Affiliated Hospital of Yanbian University

Yanbian, Jilin, 133000, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 70004, China

RECRUITING

The Second Hospital of Shandong University

Jinan, Shandong, 250033, China

RECRUITING

Affiliated Hospital of Weifang Medical University

Weifang, Shandong, 261031, China

RECRUITING

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

RECRUITING

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

Taiyuan No.3 Hospital

Taiyuan, Shanxi, 030012, China

RECRUITING

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

Yanan University Affiliated Hospital

Yanan, Shanxi, 716000, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646099, China

RECRUITING

Affiliated Hospital, Logistics University of People's Armed Police Force

Tianjin, Tianjin Municipality, 300163, China

RECRUITING

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, 610041, China

RECRUITING

People's Hospital of Changji Hui Autonomous Prefecture，Xinjiang

Changji, Xinjiang, 831118, China

RECRUITING

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

RECRUITING

Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital

Ürümqi, Xinjiang, 830099, China

RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

Xixi Hospital of Hangzhou

Hangzhou, Zhejiang, 310023, China

RECRUITING

Related Publications (3)

• You H, Kong Y, Hou J, Wei L, Zhang Y, Niu J, Han T, Ou X, Dou X, Shang J, Tang H, Xie Q, Ding H, Ren H, Xu X, Xie W, Liu X, Xu Y, Li Y, Li J, Chow SC, Zhuang H, Jia J. Female gender lost protective effect against disease progression in elderly patients with chronic hepatitis B. Sci Rep. 2016 Nov 28;6:37498. doi: 10.1038/srep37498.

  PMID: 27892487 BACKGROUND

• Zhang Y, Wang Y, Jiao S, Li S, Liu X, Li T, Qu Y. Nonlinear relationship between age and the risk of hepatocellular carcinoma in patients with hepatitis B virus-related cirrhosis. BMC Infect Dis. 2025 Nov 21;25(1):1635. doi: 10.1186/s12879-025-12016-9.

  PMID: 41272517 DERIVED

• Shan S, Wei W, Kong Y, Niu J, Shang J, Xie W, Zhang Y, Ren H, Tang H, Ding H, Nan Y, Dou X, Han T, Xu X, Duan Z, Wei L, Hou J, Zhuang H, You H, Jia J; CR-Hepb Study Group, Beijing, China. China Registry of Hepatitis B (CR-HepB): Protocol and implementation of a nationwide hospital-based registry of hepatitis B. Scand J Public Health. 2020 Mar;48(2):233-239. doi: 10.1177/1403494818772188. Epub 2018 May 1.

  PMID: 29716439 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic; Fibrosis

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jidong Jia, Doctor

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jidong Jia, MD

CONTACT

010-63139816; jia_jd@ccmu.edu.cn

Hong You, MD

CONTACT

010-63139019; youhongliver@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Liver Research Center

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 11, 2017
• Study Start: June 30, 2012
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (45)