Cohort of Hepatitis B Research of Amsterdam (COBRA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Public Health Service of Amsterdam.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
S. Harkisoen, Public Health Service of Amsterdam
ClinicalTrials.gov Identifier:
NCT01462981
First received: October 28, 2011
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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
Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cohort of Hepatitis B Research of Amsterdam

Resource links provided by NLM:


Further study details as provided by Public Health Service of Amsterdam:

Biospecimen Retention:   Samples With DNA

Serum, White cells


Estimated Enrollment: 172
Study Start Date: September 2011
Estimated Study Completion Date: July 2012
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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462981

Contacts
Contact: Soeradj Harkisoen, MD +31887556228 s.harkisoen@umcutrecht.nl

Locations
Netherlands
Public Health Service (GGD) Recruiting
Amsterdam, Noord-Holland, Netherlands, 1018 WT
Contact: J AR van den Hoek, MD, PhD    +31205555341    avdhoek@ggd.amsterdam.nl   
Principal Investigator: J AR van den Hoek, MD, PhD         
Sponsors and Collaborators
Public Health Service of Amsterdam
UMC Utrecht
Investigators
Principal Investigator: Andy IM Hoepelman, MD, PhD UMC Utrecht
  More Information

No publications provided

Responsible Party: S. Harkisoen, MD, Public Health Service of Amsterdam
ClinicalTrials.gov Identifier: NCT01462981     History of Changes
Other Study ID Numbers: COBRA
Study First Received: October 28, 2011
Last Updated: November 1, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on October 30, 2014