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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Patients chronically infected with hepatitis B virus

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Number of participants with antigen loss (HBeAg and HBsAg loss)

Time frame
20 years
2

Cirrhosis

Time frame
20 years
3

Hepatic decompensation

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

Time frame
20 years
4

Hepatocellular carcinoma (HCC)

The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.

Time frame
20 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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