Clinical trial NCT01462981: Cohort of Hepatitis B Research of Amsterdam
Official title: Cohort of Hepatitis B Research of Amsterdam
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Lead sponsor: Public Health Service of Amsterdam
Sponsor class: OTHER_GOV
Collaborators: name: UMC Utrecht
First posted: 2011-11-01
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 18 - 65 year in the study period with chronic hepatitis B who were HBsAg positive during pregnancy screening of which serum samples are stored at the Public Health Service.

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 is associated with the risk of HBV-related cirrhosis or mortality in a cohort of non-Asian individuals with chronic hepatitis B infection.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* HBsAg-positivity
* Serum sample available from the screening programme at the Public Health Service
* Still living and alive in Amsterdam or Diemen and address traceable by general practitioners or municipal authorities.
* Non-Asian (both parents not born in Asia)
* Between 18-65 years old
* Capable of giving informed consent and capable of traveling to the Public Health Service

Exclusion Criteria:

* Subjects coinfected with human immunodeficiency virus (HIV)
* Subjects coinfected with hepatitis D virus (HDV)
* Subjects coinfected with hepatitis C virus (HCV)
* Subjects who are unable to come to the outpatient clinic
* Subjects incapable to give informed consent due to legally incompetence

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Public Health Service (GGD)
state: Noord-Holland
Study officials:
affiliation: UMC Utrecht
name: Andy IM Hoepelman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: