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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03108794
Other study ID # CR-HepB
Secondary ID
Status Recruiting
Phase N/A
First received April 6, 2017
Last updated November 2, 2017
Start date June 30, 2012
Est. completion date December 31, 2025

Study information

Verified date November 2017
Source Beijing Friendship Hospital
Contact Jidong Jia, MD
Phone 010-63139816
Email jia_jd@ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Locations

Country Name City State
China Beijing Ditan Hospital Beijing Beijing
China Beijing Tiantan Hospital Beijing Beijing
China Beijing Youan Hospital Beijing Beijing
China Peking Union Medical College Hospital Beijing Beijing
China Peking University First Hospital Beijing Beijing
China Peking University People's Hospital Beijing Beijing
China First Hospital of Jilin University Changchun Jilin
China People's Hospital of Changji Hui Autonomous Prefecture,Xinjiang Changji Xinjiang
China Hunan Provincial People's Hospital Changsha Hunan
China Xiangya Hospital Central South University Changsha Hunan
China West China Hospital of Sichuan University Chengdu Sichuan
China The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing
China The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing
China Nanfang Hospital, Southern Medical University Guangzhou Guangdong
China Guizhou provincial people's hospital Guiyang Guizhou
China The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou
China Hainan General Hospital Haikou Hainan
China Xixi Hospital of Hangzhou Hangzhou Zhejiang
China The Second Hospital of Shandong University Jinan Shandong
China First Affiliated Hospital of Kunming Medical University Kunming Yunnan
China Lanzhou University Second Hospital Lanzhou Gansu
China The First Hospital of Lanzhou University Lanzhou Gansu
China The Affiliated Hospital of Southwest Medical University Luzhou Sichuan
China Shanghai Public Health Clinical Center Shanghai Shanghai
China Shanghai Ruijin Hospital Shanghai Shanghai
China Shengjing Hospital of China Medical University Shenyang Liaoning
China The Fifth Hospital of Shijiazhuang Shijiazhuang Hebei
China The Second Hospital of Hebei Medical University Shijiazhuang Hebei
China The Third Hospital of Hebei Medical University Shijiazhuang Hebei
China Taiyuan No.3 Hospital Taiyuan Shanxi
China The First Affiliated Hospital of Shanxi Medical University Taiyuan Shanxi
China Affiliated Hospital, Logistics University of People's Armed Police Force Tianjin Tianjin
China Tianjin Third Central Hospital Tianjin Tianjin
China First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang
China Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital Urumqi Xinjiang
China Affiliated Hospital of Weifang Medical University Weifang Shandong
China Infectious Disease Hospital of Wuhai Wuhai Inner Mongolia
China Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology Wuhan Hubei
China Zhongnan Hospital of Wuhan University Wuhan Hubei
China First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
China Yanan University Affiliated Hospital Yanan Shanxi
China The Affiliated Hospital of Yanbian University Yanbian Jilin
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China Henan Provincial People's Hospital Zhengzhou Henan

Sponsors (47)

Lead Sponsor Collaborator
Beijing Friendship Hospital Affiliated Hospital of Weifang Medical University, Affiliated Hospital, Logistics University of People's Armed Police Force, Beijing Ditan Hospital, Beijing Tiantan Hospital,Capital Medical University, Beijing YouAn Hospital, Fifth Hospital of Shijiazhuang City, First Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital Xi'an Jiaotong University, First Hospital of Jilin University, General Hospital of Ningxia Medical University, Guizhou Provincial People's Hospital, Hainan General Hospital, Hebei Medical University Third Hospital, Henan Provincial Hospital, Hunan Provincial People's Hospital, Infectious Disease Hospital of Wuhai, LanZhou University, Nanfang Hospital of Southern Medical University, Peking Union Medical College Hospital, Peking University First Hospital, Peking University People's Hospital, People's Hospital of Changji Hui Autonomous Prefecture,Xinjiang, Ruijin Hospital, Shanghai Public Health Clinical Center, Shengjing Hospital, Taiyuan No.3 Hospital, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Hospital Of Southwest Medical University, The Affiliated Hospital of Xuzhou Medical University, The Affiliated Hospital of Yanbian University, The First Affiliated Hospital of Kunming Medical College, The First Affiliated Hospital of Shanxi Medical University, The First Hospital of Lanzhou University, The Fouth Hospital of Qinghai province, The Second Affiliated Hospital of Chongqing Medical University, The Second Hospital of Hebei Medical University, The Second Hospital of Shandong University, Tianjin Third Central Hospital, Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology, West China Hospital, Wuhan University, Xiangya Hospital of Central South University, Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital, Xixi Hospital of Hangzhou, Yan'an University Affiliated Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other HBsAg loss and seroconversion rates with or without antiviral therapy 10 years
Other Quality of life 10 years
Primary Rate of liver-related events after antiviral therapy Rates of cirrhosis,decompensation and hepatocellular carcinoma with or without antiviral therapy 10 years
Secondary The HBV DNA undetectable rate with or without antiviral therapy 10 years
Secondary HBeAg loss and seroconversion rates with or without antiviral therapy 10 years
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