Cohort of Hepatitis B Research of Amsterdam (COBRA)
Recruitment status was Recruiting
Hepatitis B is a form of liver disease caused by a DNA-virus, called hepatitis B virus (HBV). Infection can result in an inflammation of the liver parenchyma with various clinical manifestations ranging from an asymptomatic course to jaundice. After contact with the virus the immunological response of the host determines the clinical outcome leading to either viral clearance or a chronic infection.
Although several factors are responsible for the development of chronic HBV-infection, one of the factors is a weak and transient CD8+ T-cell responses after HBV infection. In chronic hepatitis B, inflammation can lead to scarring which is the driving force to fibrosis and cirrhosis. Some immunological parameters, like a newly discovered subset of IL-17 producing T helper cells (Th17 cells), may influence the disease progression of HBV. In the cirrhotic patient, eventually there is an increased risk of hepatocellular carcinoma (HCC) leading to liver failure.
Recent literature in Asian patients with chronic hepatitis B showed that serum HBV viral load is a strong predictor for the development of cirrhosis, independent of hepatitis B e- antigen status and serum alanine transaminase level. It is unclear whether these results can be extrapolated to non-Asian (Caucasian and African) populations because of differences in host (HLA background) and viral (HBV genotype) factors.
The aim of this study is to elucidate the question whether historic HBV viral load is associated with the risk of HBV-related cirrhosis or mortality in a cohort of non-Asian individuals with chronic hepatitis B infection.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Cohort of Hepatitis B Research of Amsterdam|
Serum, White cells
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||July 2012|
During one visit, the nurse will assess the quality of life of the included patients with the use of a health assessment questionnaire. This questionnaire is derived from a standardized questionnaire to assess the quality of life in patients, the SF-36. Participation will require a single visit to the outpatient clinic of Public Health Service. During this visit a short history and physical examination related to chronic liver disease will be performed. During the same visit a single venapunction and a single hepatic elastography (fibroscan) will be performed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462981
|Contact: Soeradj Harkisoen, MDfirstname.lastname@example.org|
|Public Health Service (GGD)||Recruiting|
|Amsterdam, Noord-Holland, Netherlands, 1018 WT|
|Contact: J AR van den Hoek, MD, PhD +31205555341 email@example.com|
|Principal Investigator: J AR van den Hoek, MD, PhD|
|Principal Investigator:||Andy IM Hoepelman, MD, PhD||UMC Utrecht|