"Real-life" Cohort of Patients With Chronic Hepatitis B Virus Infection
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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 |
- 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 |
Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France
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| 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 | |
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 June 17, 2013