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

Hepatitis B Cohort: Predictive Factors of the Outcome of Chronic Hepatitis B Virus Infection

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01732081

Enrollment

3000

Registered

2012-11-22

Start date

2011-01-31

Completion date

2021-01-31

Last updated

2012-11-22

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

Conditions

Hepatitis B

Keywords

Hepatitis B

Brief summary

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.

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) * Decompensated cirrhosis * History of liver transplantation * History of hepatocellular carcinoma (HCC)

Design outcomes

Primary

Measure	Time frame
to determine factors associated with the outcome of chronic HBV infection	10 years

Countries

France

Outcome results