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

Information source: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B; Hepatitis B, Chronic; End Stage Liver Disease; Carcinoma, Hepatocellular

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Universitaire Ziekenhuizen Leuven

Official(s) and/or principal investigator(s):
MahmoudReza Pourkarim, PhD, Principal Investigator, Affiliation: UZ Leuven campus Gasthuisberg, Herestraat 49. 3000 Leuven, Belgium


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.

Clinical Details

Official title: Assessment of Hepatitis B Virus Intra-host Population and Host-specific Immune Marker Diversity With Next-generation Sequencing: From Chronic Infection to End-stage Liver Disease and Liver Cancer

Study design: Time Perspective: Prospective

Primary outcome: genetic variants of Hepatitis B

Secondary outcome: genetic variation in host-specific immune markers

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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

University Hospitals Leuven campus Gasthuisberg, Leuven, Flemish Brabant 3000, Belgium
Additional Information

Starting date: April 2014
Last updated: May 22, 2014

Page last updated: August 20, 2015

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