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

Hepatitis B, Chronic Clinical Trial

— OCEHBV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107483
• Other study ID #: endotoxaemiaobservation
• Status: Completed
• Phase: N/A
• First received: April 16, 2010
• Last updated: May 6, 2010
• Start date: December 2009
• Est. completion date: March 2010

Study information

• Verified date: January 2010
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 24 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endotoxemia
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

Locations

Country	Name	City	State
China	The Third Affliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma levels of endotoxin		4 months	No
Secondary	serum albumin level		4 months	No
Secondary	Plasma cytokine concentration	ELISA kits were used to assess in duplicate the plasma concentrations of IL-6, IL-10, TNFa, and sICAM-1 (Bender, Vienna, Austria).	4 months	No
Secondary	serum low density lipoprotein (LDL) level		4 months	No
Secondary	serum high density lipoprotein (HDL) level		4 months	No
Secondary	plasma sCD14 level	ELISA kits were used to assess in duplicate the plasma concentrations of soluble CD14 (sCD14) (R&D Systems, Minneapolis, MN).	4 months	No