Cohort of Hepatitis B Research of Amsterdam (COBRA)

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.

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 172

Contacts and Locations

• Study Contact: Name: Soeradj Harkisoen, MD; Phone Number: +31887556228; Email: s.harkisoen@umcutrecht.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1018 WT
      • Recruiting
      • Public Health Service (GGD)
      • Contact: J AR van den Hoek, MD, PhD; Phone Number: +31205555341; Email: avdhoek@ggd.amsterdam.nl
      • Principal Investigator: J AR van den Hoek, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Public Health Service of Amsterdam
• Collaborators: UMC Utrecht
• Investigators: Principal Investigator: Andy IM Hoepelman, MD, PhD, UMC Utrecht

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: October 28, 2011
• First Submitted That Met QC Criteria: October 28, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2011
• Last Update Submitted That Met QC Criteria: November 1, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A
• Other Study ID Numbers: COBRA