Assessment of Hepatitis B Virus Intra-host Population and Host-specific Immune Marker Diversity

Universitaire Ziekenhuizen KU Leuven

Status: Unknown

Conditions: Hepatitis B, Chronic; Carcinoma, Hepatocellular; Hepatitis B; End Stage Liver Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02148562

12G1714N (Other Grant/Funding Number)

S56121

Details and patient eligibility

About

In this project proposal, the investigators will investigate the genetic alterations of Hepatitis B Virus (HBV) strains circulating in Belgian patients who developed end stage liver disease. Additionally, the investigators will compare and link these data sets with three genetic factors involved in immune system response.

Full description

This project proposes to identify and characterize the genetic alterations associated with intra-host evolution of HBV from a chronically infection status to an end-stage liver disease status.

Enrollment: 274 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Study group:

• Clinical diagnosis of advanced liver disease related to chronic Hepatitis B infection (cirrhosis, hepatocellular carcinoma,..)
• Availability of serum samples

Control group:

• Clinical diagnosis of liver disease related to chronic Hepatitis B infection in a pre-advanced stage
• Matched demographic and geographic characteristics to study group
• Availability of serum samples

Exclusion criteria

• Liver disease caused by other hepato-tropic viruses
• Patients with auto-immune diseases

Trial design

274 participants in 2 patient groups

Chronic Hepatitis B

Description:

Diagnosis of Hepatitis B related liver disease in a pre-advanced stage

End stage liver disease

Description:

Diagnosis of advanced liver disease related to Hepatitis B