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

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

• Registration Number: NCT02148562
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-04
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-22
• Last Update Submitted: 2014-05-22
• Study First Posted: 2014-05-28
• Last Update Posted: 2014-05-28
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 274

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
genetic variants of Hepatitis B	6 months	Virus variants will be identified by amino acid or nucleotide variations (insertions or deletions) in different Open Readind Frames (ORFs) of the HBV genome by using next-generation sequencing.; Comparison of virus variants within one patient Comparison of virus variants between patients with end stage liver disease and patients with a chronic Hepatitis B infection.; Determination of the viral load by quantitative Polymerase Chain Reaction (PCR).

Secondary Outcome Measures

Name	Time	Method
genetic variation in host-specific immune markers	at day of enrollment	Amplification of HLA-A, HLA-B, HLA-C class I and HLA class II using PCR methods and next-generation sequencing; Amplification of KIR genes: 2DS1, 2DS2, 2DS3, 2DS4, 2DS5, 3DS1 and 1D, 2DL1 2DL2, 2DL3, 2DL5 and 3DL1 using PCR methods and next-generation sequencing; Amplification of SNPs in TNF alfa, TGF beta1 and IFN-R using PCR methods and next-generation sequencing

Trial Locations

Locations (1)

University Hospitals Leuven campus Gasthuisberg; 🇧🇪 Leuven, Flemish Brabant, Belgium