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

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT03108794

Acronym / sponsor ID

CR-HepB

Conditions

Chronic Hepatitis B

Keywords

hepatitis B，registry,cirrhosis, HCC

Study type

Observational

Recruitment status

Unknown status

Enrolment

200,000 participants (estimated)

Lead sponsor

Beijing Friendship HospitalUniversity, hospital or other

Collaborators

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

Study start

30 Jun 2012 (actual)

Primary completion

31 Dec 2022 (estimated)

Study completion

31 Dec 2025 (estimated)

First posted

11 Apr 2017 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

10 Years

Number of arms

7

Who may qualify

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Rate of liver-related events after antiviral therapy

   Time frame: 10 years

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

Results and safety

Results are not available in the source record.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
• Background: PubMed 27892487You 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.
• Derived from this study: PubMed 41272517Zhang 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.
• Derived from this study: PubMed 29716439Shan 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.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

45 sites in 1 country: see every site and its status.