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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01107483
Acronym
OCEHBV
Enrollment
140
Registered
2010-04-21
Start date
2009-12-31
Completion date
2010-03-31
Last updated
2010-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Keywords

endotoxaemia

Brief summary

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).

Detailed description

1. 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. 2. 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. 3. ELISA ELISA kits were used to assess in duplicate the plasma concentrations of IL-6, IL-10, TNFα, sICAM-1 and sCD14.

Interventions

None listed

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
24 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
plasma levels of endotoxin4 months

Secondary

MeasureTime frameDescription
serum albumin level4 months
Plasma cytokine concentration4 monthsELISA kits were used to assess in duplicate the plasma concentrations of IL-6, IL-10, TNFα, and sICAM-1 (Bender, Vienna, Austria).
serum low density lipoprotein (LDL) level4 months
serum high density lipoprotein (HDL) level4 months
plasma sCD14 level4 monthsELISA kits were used to assess in duplicate the plasma concentrations of soluble CD14 (sCD14) (R&D Systems, Minneapolis, MN).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026