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

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03108794

Collaborator

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), Taiyuan No.3 Hospital (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), 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), The First Affiliated Hospital of Kunming Medical College (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 Fouth 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 (Other), General Hospital of Ningxia Medical University (Other), Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology (Other), Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital (Other), Peking University People's Hospital (Other), Nanfang Hospital of 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 (Other), Logistics University of Chinese People's Armed Police Forces (Other), People's Hospital of Changji Hui Autonomous Prefecture，Xinjiang (Other)

200,000

Enrollment

Locations

162

Anticipated Duration (Months)

4444.4

Patients Per Site

27.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 30, 2012

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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: by liver histology: Ishak fibrosis stage 5-6 or METAVIR F4. endoscopy-proven gastroesophageal varices, afrter excluding non-cirrhotic portal hypertension. at least 2 features of cirrhosis: 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; PLT<100×109/L without other causes; Serum album in<35 g/L or INR>1.3 or PT prolongs>3s; 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.

Outcome Measures

Primary Outcome Measures

Rate of liver-related events after antiviral therapy [10 years]
Rates of cirrhosis,decompensation and hepatocellular carcinoma with or without antiviral therapy

Secondary Outcome Measures

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 Outcome Measures

HBsAg loss and seroconversion rates with or without antiviral therapy [10 years]
Quality of life [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Ditan Hospital	Beijing	Beijing	China	100015
2	Peking Union Medical College Hospital	Beijing	Beijing	China	100032
3	Peking University First Hospital	Beijing	Beijing	China	100034
4	Peking University People's Hospital	Beijing	Beijing	China	100044
5	Beijing Tiantan Hospital	Beijing	Beijing	China	100050
6	Beijing Youan Hospital	Beijing	Beijing	China	100069
7	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400010
8	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400016
9	Lanzhou University Second Hospital	Lanzhou	Gansu	China	730030
10	The First Hospital of Lanzhou University	Lanzhou	Gansu	China	730099
11	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China	510515
12	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou	China	550004
13	Guizhou provincial people's hospital	Guiyang	Guizhou	China
14	Hainan General Hospital	Haikou	Hainan	China	570311
15	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050000
16	The Fifth Hospital of Shijiazhuang	Shijiazhuang	Hebei	China	050021
17	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050051
18	Henan Provincial People's Hospital	Zhengzhou	Henan	China	450003
19	Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology	Wuhan	Hubei	China	430022
20	Zhongnan Hospital of Wuhan University	Wuhan	Hubei	China	430071
21	Hunan Provincial People's Hospital	Changsha	Hunan	China	410005
22	Xiangya Hospital Central South University	Changsha	Hunan	China	410008
23	Infectious Disease Hospital of Wuhai	Wuhai	Inner Mongolia	China	016099
24	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China	221006
25	First Hospital of Jilin University	Changchun	Jilin	China	130021
26	The Affiliated Hospital of Yanbian University	Yanbian	Jilin	China	133000
27	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China	110004
28	General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China	70004
29	The Second Hospital of Shandong University	Jinan	Shandong	China	250033
30	Affiliated Hospital of Weifang Medical University	Weifang	Shandong	China	261031
31	Shanghai Ruijin Hospital	Shanghai	Shanghai	China	200025
32	Shanghai Public Health Clinical Center	Shanghai	Shanghai	China	201508
33	The First Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi	China	030001
34	Taiyuan No.3 Hospital	Taiyuan	Shanxi	China	030012
35	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi	China	710061
36	Yanan University Affiliated Hospital	Yanan	Shanxi	China	716000
37	West China Hospital of Sichuan University	Chengdu	Sichuan	China	610041
38	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan	China	646099
39	Affiliated Hospital, Logistics University of People's Armed Police Force	Tianjin	Tianjin	China	300163
40	Tianjin Third Central Hospital	Tianjin	Tianjin	China	610041
41	People's Hospital of Changji Hui Autonomous Prefecture，Xinjiang	Changji	Xinjiang	China	831118
42	First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang	China	830054
43	Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital	Urumqi	Xinjiang	China	830099
44	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan	China	650032
45	Xixi Hospital of Hangzhou	Hangzhou	Zhejiang	China	310023

Sponsors and Collaborators

Beijing Friendship Hospital
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
Taiyuan No.3 Hospital
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
The First Affiliated Hospital of Kunming Medical College
The Affiliated Hospital of Xuzhou Medical University
The Affiliated Hospital of Yanbian University
First Affiliated Hospital of Chongqing Medical University
The Fouth 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,Tong Ji Medical College,Huazhong University of Science and Technology
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
Peking University People's Hospital
Nanfang Hospital of 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