Cohort of Hepatitis B Research of Amsterdam (COBRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
UMC Utrecht
Information provided by (Responsible Party):
S. Harkisoen, Public Health Service of Amsterdam

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.

Condition or disease
Hepatitis B

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.

Study Type : Observational
Estimated Enrollment : 172 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cohort of Hepatitis B Research of Amsterdam
Study Start Date : September 2011
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples With DNA
Serum, White cells

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01462981

Contact: Soeradj Harkisoen, MD +31887556228

Public Health Service (GGD) Recruiting
Amsterdam, Noord-Holland, Netherlands, 1018 WT
Contact: J AR van den Hoek, MD, PhD    +31205555341   
Principal Investigator: J AR van den Hoek, MD, PhD         
Sponsors and Collaborators
Public Health Service of Amsterdam
UMC Utrecht
Principal Investigator: Andy IM Hoepelman, MD, PhD UMC Utrecht

Responsible Party: S. Harkisoen, MD, Public Health Service of Amsterdam Identifier: NCT01462981     History of Changes
Other Study ID Numbers: COBRA
First Posted: November 1, 2011    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections