A Nation-wide Hospital-based Hepatitis B Registry:China Registry of Hepatitis B
NCT ID: NCT03108794
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200000 participants
OBSERVATIONAL
2012-06-30
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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).
No interventions assigned to this group
Decompensated cirrhosis
Decompensated cirrhosis was diagnosed based on the presence of ascites, bleeding esophageal varices and/or hepatic encephalopathy in cirrhotic patients.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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Beijing YouAn Hospital
OTHER
The First Hospital of Jilin University
OTHER
Henan Provincial People's Hospital
OTHER
Beijing Ditan Hospital
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
LanZhou University
OTHER
The Second Affiliated Hospital of Chongqing Medical University
OTHER
West China Hospital
OTHER
The Third People's Hospital of Taiyuan
OTHER
Hebei Medical University Third Hospital
OTHER
Shengjing Hospital
OTHER
Tianjin Third Central Hospital
OTHER
Peking University First Hospital
OTHER
Peking Union Medical College Hospital
OTHER
The Affiliated Hospital Of Southwest Medical University
OTHER
Shanghai Public Health Clinical Center
OTHER_GOV
Ruijin Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Xiangya Hospital of Central South University
OTHER
Beijing Tiantan Hospital
OTHER
Wuhan University
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
The Affiliated Hospital of Yanbian University
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
The Fourth People's Hospital of Qinghai Province
OTHER
Weifang Medical University
OTHER
Hunan Provincial People's Hospital
OTHER
The Second Hospital of Hebei Medical University
OTHER
Xixi Hospital of Hangzhou
UNKNOWN
General Hospital of Ningxia Medical University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
UNKNOWN
Peking University People's Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
Guizhou Provincial People's Hospital
OTHER
Hainan General Hospital
OTHER
The Second Hospital of Shandong University
OTHER
The First Affiliated Hospital of Shanxi Medical University
OTHER
Fifth Hospital of Shijiazhuang City
OTHER
Yan'an University Affiliated Hospital
OTHER
Infectious Disease Hospital of Wuhai
UNKNOWN
Logistics University of Chinese People's Armed Police Forces
OTHER
People's Hospital of Changji Hui Autonomous Prefecture，Xinjiang
UNKNOWN
Beijing Friendship Hospital
OTHER
Responsible Party
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Jidong Jia
Liver Research Center
Principal Investigators
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Jidong Jia, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Locations
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Beijing Ditan Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Beijing Youan Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Guizhou provincial people's hospital
Guiyang, Guizhou, China
Hainan General Hospital
Haikou, Hainan, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Infectious Disease Hospital of Wuhai
Wuhai, Inner Mongolia, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
First Hospital of Jilin University
Changchun, Jilin, China
The Affiliated Hospital of Yanbian University
Yanbian, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The Second Hospital of Shandong University
Jinan, Shandong, China
Affiliated Hospital of Weifang Medical University
Weifang, Shandong, China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Taiyuan No.3 Hospital
Taiyuan, Shanxi, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Yanan University Affiliated Hospital
Yanan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Affiliated Hospital, Logistics University of People's Armed Police Force
Tianjin, Tianjin Municipality, China
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, China
People's Hospital of Changji Hui Autonomous Prefecture，Xinjiang
Changji, Xinjiang, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
Ürümqi, Xinjiang, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Xixi Hospital of Hangzhou
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Wen Xie, MD
Role: primary
Xiaoqing Liu, MD
Role: primary
Xiaoyuan Xu, MD
Role: primary
Lai Wei, doctor
Role: primary
Youqing Xu, MD
Role: primary
Huiguo Ding, MD
Role: primary
Hong Ren, MD
Role: primary
Wenxiang Huang, MD
Role: primary
Lingyi Zhang, MD
Role: primary
Xiaorong Mao, MD
Role: primary
Jinlin Hou, MD
Role: primary
Mingliang Cheng, MD
Role: primary
Xinhua Luo, MD
Role: primary
Feng Lin, MD
Role: primary
Xiaolan Zhang, MD
Role: primary
Huanwei Deng, MD
Role: primary
Yuemin Nan, MD
Role: primary
Jia Shang, MD
Role: primary
Dongliang Yang, MD
Role: primary
Yong Xiong, MD
Role: primary
Xiaoxuan Hu, MD
Role: primary
Yan Huang, MD
Role: primary
Caixia Yang, MD
Role: primary
Xuebing Yan, MD
Role: primary
Junqi Niu, MD
Role: primary
Hongxin Piao, MD
Role: primary
Xiaoguang Dou, MD
Role: primary
Yufang Li, MD
Role: primary
Lei Wang, MD
Role: primary
Shiping Li, MD
Role: primary
Qing Xie, MD
Role: primary
Peiyan Ye, MD
Role: primary
Liaoyun Zhang, MD
Role: primary
Xihong Wang, MD
Role: primary
Shumei Lin, MD
Role: primary
Guanghua Xu, MD
Role: primary
Hong Tang, MD
Role: primary
Cunliang Deng, MD
Role: primary
Hai Li, MD
Role: primary
Tao Han, MD
Role: primary
Weijin Gong, MD
Role: primary
Yuexin Zhang, MD
Role: primary
Xiaozhong Wang, MD
Role: primary
Wu Li, MD
Role: primary
Shourong Liu, MD
Role: primary
References
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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.
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.
Other Identifiers
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CR-HepB
Identifier Type: -
Identifier Source: org_study_id