Cohort of Hepatitis B Research of Amsterdam

NCT01462981 | Unknown

• 1 other identifier: COBRA
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Public Health Service of Amsterdam: lead
• UMC Utrecht: collaborator

Study Sites (1)

Public Health Service (GGD)

Amsterdam, North Holland, 1018 WT, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, White cells

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Andy IM Hoepelman, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soeradj Harkisoen, MD

CONTACT

+31887556228; s.harkisoen@umcutrecht.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 1, 2011
• Study Start: September 1, 2011
• Study Completion: July 1, 2012
• Last Updated: November 2, 2011

Record last verified: 2011-11

Locations

NL (1)