|- candidate number||10274|
|- NTR Number||NTR3035|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-aug-2011|
|- Secondary IDs||NL34329.018.10 CCMO|
|- Public Title||Cohort of hepatitis B research in Amsterdam.|
|- Scientific Title||Cohort of hepatitis B research in Amsterdam.|
|- hypothesis||The 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
|- Healt Condition(s) or Problem(s) studied||Hepatocellular carcinoma, Liver cirrhosis, Hepatitis B, Viral load|
|- Inclusion criteria||1. 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 criteria||1. 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 received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-apr-2011|
|- planned closingdate||31-dec-2013|
|- Target number of participants||172|
|- Interventions||1. Venapunction;|
3. Health assessment questionnaire.
|- Primary outcome||Main study parameters are any of following complications:|
1. Liver cirrhosis;
2. Death related to HBV morbidity.
|- Secondary outcome||Secondary study parameters are:|
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.
|- Timepoints||Historic (more than 15 years ago) bloodsample compared to present bloodsample.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. MD. S. Harkisoen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. MD. S. Harkisoen|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), GGD Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||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 (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)|
|- RECORD||24-aug-2011 - 8-sep-2011|