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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01732081     History of Changes
Other Study ID Numbers: 5452
Study First Received: November 16, 2012
Last Updated: November 16, 2012
Health Authority: France: Ministère de l'Enseignement supérieur et de la Recherche

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

Additional relevant MeSH terms:
Encephalitis, Herpes Simplex
Encephalitis, Viral
Encephalitis
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Virus Diseases
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Central Nervous System Viral Diseases
Herpesviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014