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

This study is currently recruiting participants.
Verified November 2012 by University Hospital, Strasbourg, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732081
First Posted: November 22, 2012
Last Update Posted: November 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  Purpose
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.

Condition
Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hepatitis B Cohort: Predictive Factors of the Outcome of Chronic Hepatitis B Virus Infection

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • to determine factors associated with the outcome of chronic HBV infection [ Time Frame: 10 years ]

Estimated Enrollment: 3000
Study Start Date: January 2011
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with chronic hepatitis B virus infection
Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732081


Locations
France
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: François HABERSETZER, MD    +33(0)3 69 55 10 09    francois.habersetzer@chru-strasbourg.fr   
Principal Investigator: François HABERSETZER, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01732081     History of Changes
Other Study ID Numbers: 5452
First Submitted: November 16, 2012
First Posted: November 22, 2012
Last Update Posted: November 22, 2012
Last Verified: November 2012

Keywords provided by University Hospital, Strasbourg, France:
Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections


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