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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03108794
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Beijing YouAn Hospital
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
Information provided by (Responsible Party):
Jidong Jia, Beijing Friendship Hospital

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
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Nation-wide Hospital-based Hepatitis B Registry:China Registry of Hepatitis B
Actual Study Start Date : June 30, 2012
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Rate of liver-related events after antiviral therapy [ Time Frame: 10 years ]
    Rates of cirrhosis,decompensation and hepatocellular carcinoma with or without antiviral therapy


Secondary Outcome Measures :
  1. The HBV DNA undetectable rate with or without antiviral therapy [ Time Frame: 10 years ]
  2. HBeAg loss and seroconversion rates with or without antiviral therapy [ Time Frame: 10 years ]

Other Outcome Measures:
  1. HBsAg loss and seroconversion rates with or without antiviral therapy [ Time Frame: 10 years ]
  2. Quality of life [ Time Frame: 10 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The registry is a multicentre and observational study enrolling patients with hepatitis B across China. The main criteria for patients registration within the system was 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. All potential subjects meeting enrollment criteria are offered the opportunity to participate.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108794


Contacts
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Contact: Jidong Jia, MD 010-63139816 jia_jd@ccmu.edu.cn
Contact: Hong You, MD 010-63139019 youhongliver@ccmu.edu.cn

Locations
Show Show 45 study locations
Sponsors and Collaborators
Beijing Friendship Hospital
Beijing YouAn Hospital
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
Investigators
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Principal Investigator: Jidong Jia, Doctor Beijing Friendship Hospital
Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jidong Jia, Liver Research Center, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT03108794    
Other Study ID Numbers: CR-HepB
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jidong Jia, Beijing Friendship Hospital:
hepatitis B,registry,cirrhosis, HCC
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic