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

May 22, 2014 updated by: MahmoudReza Pourkarim, Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

274

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • University Hospitals Leuven Campus Gasthuisberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with liver disease related to Hepatitis B in a pre-advanced (chronic infection) and advanced stage (end-stage liver diseases) treated at the Hepatology Department of University Hospital of Leuven

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic Hepatitis B
Diagnosis of Hepatitis B related liver disease in a pre-advanced stage
End stage liver disease
Diagnosis of advanced liver disease related to Hepatitis B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
genetic variants of Hepatitis B
Time Frame: 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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
genetic variation in host-specific immune markers
Time Frame: 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
at day of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Fund for Scientific Research, Flanders, Belgium

Investigators

  • Principal Investigator: MahmoudReza Pourkarim, PhD, UZ Leuven campus Gasthuisberg, Herestraat 49. 3000 Leuven, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

May 22, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 22, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S56121
  • 12G1714N (Other Grant/Funding Number: Fund for Scientific Research Flanders)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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