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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02148562
• Other study ID #: S56121
• Secondary ID: 12G1714N
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 4, 2014
• Last updated: May 22, 2014
• Start date: April 2014
• Est. completion date: December 2017

Study information

• Verified date: May 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 274
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• End Stage Liver Disease
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Liver Diseases

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven campus Gasthuisberg	Leuven	Flemish Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	genetic variants of Hepatitis B	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	No
Secondary	genetic variation in host-specific immune markers	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	No