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Cohort of hepatitis B research in Amsterdam.


- candidate number10274
- NTR NumberNTR3035
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-aug-2011
- Secondary IDsNL34329.018.10 CCMO
- Public TitleCohort of hepatitis B research in Amsterdam.
- Scientific TitleCohort of hepatitis B research in Amsterdam.
- ACRONYMCOBRA
- hypothesisThe aim of this study is to elucidate the question whether historic HBV viral load (in samples taken from 1989 1996 during pregnancy) is associated with the risk of HBVrelated cirrhosis or mortality in a cohort of non-Asian individuals with chronic hepatitis B infection.
- Healt Condition(s) or Problem(s) studiedHepatocellular carcinoma, Liver cirrhosis, Hepatitis B, Viral load
- Inclusion criteria1. HBsAg-positivity;
2. Serum sample available from the screening programme at the Public Health Service;
3. Still living and alive in Amsterdam or Diemen and address traceable by general practitioners or municipal authorities;
4. Non-Asian (both parents not born in Asia);
5. Between 18-65 years old;
6. Capable of giving informed consent and capable of traveling to the Public Health Service.
- Exclusion criteria1. Subjects coinfected with human immunodeficiency virus (HIV), hepatitis D virus (HDV) or hepatitis C virus (HCV);
2. Subjects who are unable to come to the outpatient clinic;
3. Subjects incapable to give informed consent due to legally incompetence.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-apr-2011
- planned closingdate31-dec-2013
- Target number of participants172
- Interventions1. Venapunction;
2. Fibroscan;
3. Health assessment questionnaire.
- Primary outcomeMain study parameters are any of following complications:
1. Liver cirrhosis;
2. Death related to HBV morbidity.
- Secondary outcomeSecondary study parameters are:
1. HCC;
2. Liver transplantation;
3. End-stage liver disease (Child-Pugh B or C);
4. Viral load of hepatitis B (comparison of historic and follow-up serum samples);
5. Parameters of activation, exhaustion and apoptosis in various subsets of immunological cells.
- TimepointsHistoric (more than 15 years ago) bloodsample compared to present bloodsample.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. MD. S. Harkisoen
- CONTACT for SCIENTIFIC QUERIESDrs. MD. S. Harkisoen
- Sponsor/Initiator University Medical Center Utrecht (UMCU), GGD Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Gilead
- PublicationsN/A
- Brief summaryHepatitis 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 (insamples taken from 1989 - 1996 during pregnancy) is associated with the risk of HBVrelated cirrhosis or mortality in a cohort of non-Asian individuals with chronic hepatitis B infection.
- Main changes (audit trail)
- RECORD24-aug-2011 - 8-sep-2011


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