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

NCT ID: NCT02148562

Last Updated: 2014-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

274 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Hepatitis B Hepatitis B, Chronic End Stage Liver Disease Carcinoma, Hepatocellular

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic Hepatitis B

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

No interventions assigned to this group

End stage liver disease

Diagnosis of advanced liver disease related to Hepatitis B

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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MahmoudReza Pourkarim

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MahmoudReza Pourkarim, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven campus Gasthuisberg, Herestraat 49. 3000 Leuven, Belgium

Locations

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University Hospitals Leuven campus Gasthuisberg

Leuven, Flemish Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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12G1714N

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S56121

Identifier Type: -

Identifier Source: org_study_id

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