"Real-life" Cohort of Patients With Chronic Hepatitis B Virus Infection

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Hepatitis B

Study type: Observational

Funder types: Other

Identifiers

NCT01732081

5452

Details and patient eligibility

About

It is estimated that 350-400 million people worldwide are chronically infected with hepatitis B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of chronic HBV infection and are responsible of about 500,000 deaths each year. Although some predictive factors of the outcome of chronic HBV infection were reported, it remains needed to more precisely determine the factors which are associated with the outcome in non-selected patients. Indeed, these factors should help to identify patients who are likely to have a better or worse evolution of their chronic HBV infection over time and thus, to adapt their clinical management and monitoring.Therefore, our purpose is to constitute a "real-life" cohort of non-selected patients to create a database of epidemiological, clinical, biological, virological and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No 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)
• Decompensated cirrhosis
• History of liver transplantation
• History of hepatocellular carcinoma (HCC)

Trial design

3,000 participants in 1 patient group

Patients with chronic hepatitis B virus infection

Description:

Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France