"Real-life" Cohort of Patients With Chronic Hepatitis B Virus Infection
| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 16, 2012 |
| Last Updated Date | November 16, 2012 |
| Start Date ICMJE | January 2011 |
| Estimated Primary Completion Date | January 2021 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
to determine factors associated with the outcome of chronic HBV infection [ Time Frame: 10 years ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | No Changes Posted |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | "Real-life" Cohort of Patients With Chronic Hepatitis B Virus Infection |
| Official Title ICMJE | Hepatitis B Cohort: Predictive Factors of the Outcome of Chronic Hepatitis B Virus Infection |
| 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France |
| Condition ICMJE | Hepatitis B |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Patients with chronic hepatitis B virus infection
Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Estimated Enrollment ICMJE | 3000 |
| Estimated Completion Date | January 2021 |
| Estimated Primary Completion Date | January 2021 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | Not Provided |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Not Provided |
| Location Countries ICMJE | France |
| Administrative Information | |
| NCT Number ICMJE | NCT01732081 |
| Other Study ID Numbers ICMJE | 5452 |
| Has Data Monitoring Committee | No |
| Responsible Party | University Hospital, Strasbourg, France |
| Study Sponsor ICMJE | University Hospital, Strasbourg, France |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | University Hospital, Strasbourg, France |
| Verification Date | November 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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