Cohort of Hepatitis B Research of Amsterdam

Hepatitis B Clinical Trial

— COBRA  

Official title:

Cohort of Hepatitis B Research of Amsterdam

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01462981
• Other study ID #: COBRA
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2011
• Last updated: November 1, 2011
• Start date: September 2011
• Est. completion date: July 2012

Study information

• Verified date: November 2011
• Source: Public Health Service of Amsterdam
• Contact: Soeradj Harkisoen, MD
• Phone: +31887556228
• Email: s.harkisoen[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Locations

Country	Name	City	State
Netherlands	Public Health Service (GGD)	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Public Health Service of Amsterdam	UMC Utrecht

Country where clinical trial is conducted

Netherlands,