Real-life Cohort Study on Patients With Chronic HBV Infection in Jiangsu

Real-life Cohort Study on Patients With Chronic Hepatitis B Virus Infection in Jiangsu

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03097952

Enrollment

20000

Registered

2017-03-31

Start date

2008-01-31

Completion date

2030-12-31

Last updated

2017-03-31

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

Conditions

Hepatitis B， Chronic

Brief summary

Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide. Patients with chronic HBV infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death. Although some predictive factors of the outcome of chronic HBV infection were identified, more precisely determine the factors which are associated with the outcome in non-selected patients with chronic HBV infection are still needed. The investigators purpose is to constitute a observational cohort of non-selected Chinese patients to create a database of epidemiological, clinical, biological, virological, immunologic and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)

Exclusion criteria

* Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV) * History of liver transplantation * History of hepatocellular carcinoma (HCC)

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with antigen loss (HBeAg and HBsAg loss)	20 years	—
Cirrhosis	20 years	—
Hepatic decompensation	20 years	Development of hepatic decompensation will be defined by any of the following events: (1) Ascites or hepatic hydrothorax; (2)Variceal or portal hypertensive bleeding; (3)Hepatic encephalopathy
Hepatocellular carcinoma (HCC)	20 years	The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.
Death	20 years	Date and cause of death will be recorded.

Countries

China

Contacts

Primary ContactChao Wu, M.D., Ph.D

dr.wu@nju.edu.cn86-25-83105890

Backup ContactRui Huang, M.D., Ph.D.

doctor_hr@126.com

Outcome results