A Nation-wide Hospital-based Hepatitis B Registry:China Registry of Hepatitis B
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|ClinicalTrials.gov Identifier: NCT03108794|
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : November 6, 2017
|Condition or disease|
|Chronic Hepatitis B|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200000 participants|
|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|
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.
Diagnosis of compensated cirrhosis can be made if one of the following criteria was met:
Decompensated cirrhosis was diagnosed based on the presence of ascites, bleeding esophageal varices and/or hepatic encephalopathy in cirrhotic patients.
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.
- Rate of liver-related events after antiviral therapy [ Time Frame: 10 years ]Rates of cirrhosis,decompensation and hepatocellular carcinoma with or without antiviral therapy
- The HBV DNA undetectable rate with or without antiviral therapy [ Time Frame: 10 years ]
- HBeAg loss and seroconversion rates with or without antiviral therapy [ Time Frame: 10 years ]
- HBsAg loss and seroconversion rates with or without antiviral therapy [ Time Frame: 10 years ]
- Quality of life [ Time Frame: 10 years ]
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
|Contact: Jidong Jia, MDemail@example.com|
|Contact: Hong You, MDfirstname.lastname@example.org|
|Principal Investigator:||Jidong Jia, Doctor||Beijing Friendship Hospital|