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

Status: Recruiting
Location: See all (45) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• HBsAg-positivity over a continuous six months.

Locations
Other Locations
China
Beijing Ditan Hospital
RECRUITING
Beijing
Beijing Tiantan Hospital
RECRUITING
Beijing
Beijing Youan Hospital
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
First Hospital of Jilin University
RECRUITING
Changchun
People's Hospital of Changji Hui Autonomous Prefecture,Xinjiang
RECRUITING
Changji
Hunan Provincial People's Hospital
RECRUITING
Changsha
Xiangya Hospital Central South University
RECRUITING
Changsha
West China Hospital of Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
The Second Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Guizhou provincial people's hospital
RECRUITING
Guiyang
The Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
Hainan General Hospital
RECRUITING
Haikou
Xixi Hospital of Hangzhou
RECRUITING
Hangzhou
The Second Hospital of Shandong University
RECRUITING
Jinan
First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Lanzhou University Second Hospital
RECRUITING
Lanzhou
The First Hospital of Lanzhou University
RECRUITING
Lanzhou
The Affiliated Hospital of Southwest Medical University
RECRUITING
Luzhou
Shanghai Public Health Clinical Center
RECRUITING
Shanghai
Shanghai Ruijin Hospital
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
The Fifth Hospital of Shijiazhuang
RECRUITING
Shijiazhuang
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The Third Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Taiyuan No.3 Hospital
RECRUITING
Taiyuan
The First Affiliated Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Affiliated Hospital, Logistics University of People's Armed Police Force
RECRUITING
Tianjin
Tianjin Third Central Hospital
RECRUITING
Tianjin
First Affiliated Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
RECRUITING
Ürümqi
Affiliated Hospital of Weifang Medical University
RECRUITING
Weifang
Infectious Disease Hospital of Wuhai
RECRUITING
Wuhai
Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology
RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi’an
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Yanan University Affiliated Hospital
RECRUITING
Yanan
The Affiliated Hospital of Yanbian University
RECRUITING
Yanbian
General Hospital of Ningxia Medical University
RECRUITING
Yinchuan
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Jidong Jia, MD
jia_jd@ccmu.edu.cn
010-63139816
Backup
Hong You, MD
youhongliver@ccmu.edu.cn
010-63139019
Time Frame
Start Date: 2012-06-30
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 200000
Treatments
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:~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).
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.
Related Therapeutic Areas
Sponsors
Collaborators: Hunan Provincial People's Hospital, Hebei Medical University Third Hospital, Peking Union Medical College Hospital, Hainan General Hospital, West China Hospital, Peking University First Hospital, People's Hospital of Changji Hui Autonomous Prefecture,Xinjiang, First Affiliated Hospital of Kunming Medical University, General Hospital of Ningxia Medical University, Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital, Xiangya Hospital of Central South University, Shengjing Hospital, The Third People's Hospital of Taiyuan, Nanfang Hospital, Southern Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Infectious Disease Hospital of Wuhai, Guizhou Provincial People's Hospital, The Affiliated Hospital of Yanbian University, First Affiliated Hospital of Xinjiang Medical University, The Affiliated Hospital Of Southwest Medical University, Beijing Ditan Hospital, The Fourth People's Hospital of Qinghai Province, The First Hospital of Jilin University, Logistics University of Chinese People's Armed Police Forces, Wuhan University, The Second Hospital of Shandong University, The Second Hospital of Hebei Medical University, Weifang Medical University, The Affiliated Hospital of Xuzhou Medical University, Ruijin Hospital, First Affiliated Hospital Xi'an Jiaotong University, Shanghai Public Health Clinical Center, Yan'an University Affiliated Hospital, Beijing YouAn Hospital, Beijing Tiantan Hospital, The Affiliated Hospital Of Guizhou Medical University, The Second Affiliated Hospital of Chongqing Medical University, Peking University People's Hospital, Fifth Hospital of Shijiazhuang City, Xixi Hospital of Hangzhou, First Affiliated Hospital of Chongqing Medical University, Tianjin Third Central Hospital, Henan Provincial People's Hospital, LanZhou University, The First Affiliated Hospital of Shanxi Medical University
Leads: Beijing Friendship Hospital

This content was sourced from clinicaltrials.gov