"Real-life" Cohort of Patients With Chronic Hepatitis B Virus Infection

NCT ID: NCT01732081

Last Updated: 2012-11-22

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

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2021-01-31

Brief Summary

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It is estimated that 350-400 million people worldwide are chronically infected with hepatitis B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of chronic HBV infection and are responsible of about 500,000 deaths each year. Although some predictive factors of the outcome of chronic HBV infection were reported, it remains needed to more precisely determine the factors which are associated with the outcome in non-selected patients. Indeed, these factors should help to identify patients who are likely to have a better or worse evolution of their chronic HBV infection over time and thus, to adapt their clinical management and monitoring.Therefore, our purpose is to constitute a "real-life" cohort of non-selected patients to create a database of epidemiological, clinical, biological, virological and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.

Detailed Description

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Conditions

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Hepatitis B

Keywords

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Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with chronic hepatitis B virus infection

Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)

Exclusion Criteria

* Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV)
* Decompensated cirrhosis
* History of liver transplantation
* History of hepatocellular carcinoma (HCC)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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François HABERSETZER, MD

Role: primary

Other Identifiers

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5452

Identifier Type: -

Identifier Source: org_study_id