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

Capital Medical University

Status: Enrolling

Conditions: Chronic Hepatitis B

Study type: Observational

Funder types: Other

Identifiers

NCT03108794

CR-HepB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

200,000 participants in 7 patient groups

Immune tolerance phase

Description:

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

Description:

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

Description:

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

Description:

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

Description:

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

Description:

Decompensated cirrhosis was diagnosed based on the presence of ascites, bleeding esophageal varices and/or hepatic encephalopathy in cirrhotic patients.

Hepatocellular carcinoma

Description:

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.