"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
1 other identifier
observational
3,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 16, 2012
CompletedFirst Posted
Study publicly available on registry
November 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedNovember 22, 2012
November 1, 2012
10 years
November 16, 2012
November 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to determine factors associated with the outcome of chronic HBV infection
10 years
Study Arms (1)
Patients with chronic hepatitis B virus infection
Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France
Eligibility Criteria
Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France
You may qualify if:
- Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2012
First Posted
November 22, 2012
Study Start
January 1, 2011
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
November 22, 2012
Record last verified: 2012-11