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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03108794

Enrollment

200000

Registered

2017-04-11

Start date

2012-06-30

Completion date

2025-12-31

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

hepatitis B，registry,cirrhosis, HCC

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of liver-related events after antiviral therapy	10 years	Rates of cirrhosis,decompensation and hepatocellular carcinoma with or without antiviral therapy

Secondary

Measure	Time frame
The HBV DNA undetectable rate with or without antiviral therapy	10 years
HBeAg loss and seroconversion rates with or without antiviral therapy	10 years

Other

Measure	Time frame
HBsAg loss and seroconversion rates with or without antiviral therapy	10 years
Quality of life	10 years

Countries

China

Contacts

Primary ContactJidong Jia, MD

jia_jd@ccmu.edu.cn010-63139816

Backup ContactHong You, MD

youhongliver@ccmu.edu.cn010-63139019

Outcome results