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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03108794
• Other study ID #: CR-HepB
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

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