Cohort of Hepatitis B Research of Amsterdam (COBRA)
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|ClinicalTrials.gov Identifier: NCT01462981|
Recruitment Status : Unknown
Verified November 2011 by S. Harkisoen, Public Health Service of Amsterdam.
Recruitment status was: Recruiting
First Posted : November 1, 2011
Last Update Posted : November 2, 2011
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||172 participants|
|Official Title:||Cohort of Hepatitis B Research of Amsterdam|
|Study Start Date :||September 2011|
|Estimated Study Completion Date :||July 2012|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|