"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:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01732081
First received: November 16, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted

November 16, 2012
November 16, 2012
January 2011
January 2021   (final data collection date for primary outcome measure)
to determine factors associated with the outcome of chronic HBV infection [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
"Real-life" Cohort of Patients With Chronic Hepatitis B Virus Infection
Hepatitis B Cohort: Predictive Factors of the Outcome of Chronic Hepatitis B Virus Infection

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Hepatitis B
Not Provided
Patients with chronic hepatitis B virus infection
Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
January 2021
January 2021   (final data collection date for primary outcome measure)

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)
Both
Not Provided
No
Not Provided
France
 
NCT01732081
5452
No
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Not Provided
University Hospital, Strasbourg, France
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP