Clinical Trials Logo

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.


Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT01462981
Study type Observational
Source Public Health Service of Amsterdam
Contact Soeradj Harkisoen, MD
Phone +31887556228
Email s.harkisoen@umcutrecht.nl
Status Recruiting
Phase N/A
Start date September 2011
Completion date July 2012

See also
  Status Clinical Trial Phase
Completed NCT01182311 - Duration of Long-term Immunity After Hepatitis B Virus Immunization
Completed NCT04971928 - Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment Phase 1
Completed NCT03285620 - A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants Phase 1
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05404919 - Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates Phase 2
Completed NCT02153320 - Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers Phase 1
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Completed NCT03567382 - Arresting Vertical Transmission of Hepatitis B Virus Phase 4
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Not yet recruiting NCT03604016 - Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Recruiting NCT03027258 - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome N/A
Terminated NCT02604199 - A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection Phase 2
Completed NCT02540538 - Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders Phase 1
Completed NCT02169674 - Hepatitis B Booster Study in Adolescence Phase 4
Completed NCT02421666 - A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV N/A
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01732354 - Study for Consolidation Period of Chronic Hepatitis B
Completed NCT01368497 - Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection Phase 3
Enrolling by invitation NCT01548326 - Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine Phase 4