Clinical trial NCT03108794: A Nation-wide Hospital-based Hepatitis B Registry:China Registry of Hepatitis B
Official title: A Nation-wide Hospital-based Hepatitis B Registry:China Registry of Hepatitis B
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis B
Keywords: hepatitis B，registry,cirrhosis, HCC
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Beijing YouAn Hospital
name: The First Hospital of Jilin University
name: Henan Provincial People's Hospital
name: Beijing Ditan Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: LanZhou University
name: The Second Affiliated Hospital of Chongqing Medical University
name: West China Hospital
name: The Third People's Hospital of Taiyuan
name: Hebei Medical University Third Hospital
name: Shengjing Hospital
name: Tianjin Third Central Hospital
name: Peking University First Hospital
name: Peking Union Medical College Hospital
name: The Affiliated Hospital Of Southwest Medical University
name: Shanghai Public Health Clinical Center
name: Ruijin Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Xiangya Hospital of Central South University
name: Beijing Tiantan Hospital
name: Wuhan University
name: First Affiliated Hospital of Kunming Medical University
name: The Affiliated Hospital of Xuzhou Medical University
name: The Affiliated Hospital of Yanbian University
name: First Affiliated Hospital of Chongqing Medical University
name: The Fourth People's Hospital of Qinghai Province
name: Weifang Medical University
name: Hunan Provincial People's Hospital
name: The Second Hospital of Hebei Medical University
name: Xixi Hospital of Hangzhou
name: General Hospital of Ningxia Medical University
name: Wuhan Union Hospital, China
name: Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
name: Peking University People's Hospital
name: Nanfang Hospital, Southern Medical University
name: The Affiliated Hospital Of Guizhou Medical University
name: Guizhou Provincial People's Hospital
name: Hainan General Hospital
name: The Second Hospital of Shandong University
name: The First Affiliated Hospital of Shanxi Medical University
name: Fifth Hospital of Shijiazhuang City
name: Yan'an University Affiliated Hospital
name: Infectious Disease Hospital of Wuhai
name: Logistics University of Chinese People's Armed Police Forces
name: People's Hospital of Changji Hui Autonomous Prefecture，Xinjiang
First posted: 2017-04-11
Enrollment: 200000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of liver-related events after antiviral therapy
timeFrame: 10 years
Secondary outcomes:
measure: The HBV DNA undetectable rate with or without antiviral therapy
timeFrame: 10 years
measure: HBeAg loss and seroconversion rates with or without antiviral therapy
timeFrame: 10 years
Other outcomes:
measure: HBsAg loss and seroconversion rates with or without antiviral therapy
timeFrame: 10 years
measure: Quality of life
timeFrame: 10 years
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Guiyang
country: China
facility: Guizhou provincial people's hospital
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Fifth Hospital of Shijiazhuang
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Wuhai
country: China
facility: Infectious Disease Hospital of Wuhai
state: Inner Mongolia
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
city: Yanbian
country: China
facility: The Affiliated Hospital of Yanbian University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Weifang
country: China
facility: Affiliated Hospital of Weifang Medical University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Taiyuan
country: China
facility: The First Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Taiyuan No.3 Hospital
state: Shanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Yanan
country: China
facility: Yanan University Affiliated Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Tianjin
country: China
facility: Affiliated Hospital, Logistics University of People's Armed Police Force
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
state: Tianjin
city: Changji
country: China
facility: People's Hospital of Changji Hui Autonomous Prefecture，Xinjiang
state: Xinjiang
city: Urumqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Urumqi
country: China
facility: Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
state: Xinjiang
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Xixi Hospital of Hangzhou
state: Zhejiang
Study officials:
affiliation: Beijing Friendship Hospital
name: Jidong Jia, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.