Skip to main content
OpenTrials
Completed

NCT Number: NCT01107483

Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic Hepatitis B Virus (HBV) Infection

This study was designed for changes in endotoxaemia, endotoxin-binding factors, sICAM-1 (soluble intracellular adhesion molecule-1), and cytokines during progression of chronic HBV infection. Patients with chronic HBV infection and healthy control are included. A limulus assay was used to measure plasma endotoxin level and ELISAs were used to measure the concentrations of interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-α (TNFα), sICAM-1, and soluble CD14 (sCD14).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis B, Chronic Bacteremia Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Endotoxemia Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Inflammation Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Toxemia Virus Diseases

Age range

24 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

About this study

  • Patients Patients with chronic HBV infection and healthy volunteers were enrolled. There were asymptomatic carriers group, patients with chronic hepatitis, patients with hepatic cirrhosis, and patients with acute on chronic liver failure.
  • Endotoxin assay Blood samples were obtained under aseptic conditions by peripheral venipuncture and using pyrogen-free syringes, needles, and glassware. Plasma samples were heated at 70℃ for 10 min. Plasma concentration was then measured in duplicate using a commercially available Limulus amebocyte lysate assay following the manufacturer's protocol.
  • ELISA ELISA kits were used to assess in duplicate the plasma concentrations of IL-6, IL-10, TNFα, sICAM-1 and sCD14.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic HBV infection
  • Diagnosis confirm to guideline of Chronic Hepatitis B and acute on chronic liver failure of the Asian Pacific Association for the Study of the Liver (APASL).

Exclusion criteria

  • All the patients had no obvious mycotic infection, Gram-negative sepsis, or bacterial infection (except from the digestive system)
  • Infection of hepatitis A, C, D, or E virus
  • Autoimmune liver disease
  • Alcoholic liver disease
  • Metabolic liver disease
  • Drug-induced liver injury
  • Parasitic disease of the hepatobiliary system
  • Malignancy
  • Serious exacerbation of cardiovascular and respiratory system diseases

Treatment and study plan

Primary outcomes

  1. plasma levels of endotoxin

    Time frame: 4 months

Secondary outcomes

  1. serum albumin level

    Time frame: 4 months

  2. Plasma cytokine concentration

    Time frame: 4 months

    ELISA kits were used to assess in duplicate the plasma concentrations of IL-6, IL-10, TNFα, and sICAM-1 (Bender, Vienna, Austria).

  3. serum low density lipoprotein (LDL) level

    Time frame: 4 months

  4. serum high density lipoprotein (HDL) level

    Time frame: 4 months

  5. plasma sCD14 level

    Time frame: 4 months

    ELISA kits were used to assess in duplicate the plasma concentrations of soluble CD14 (sCD14) (R&D Systems, Minneapolis, MN).

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic HBV Infection

Acronym: OCEHBV

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 21, 2010
Registry last updated
May 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.