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

24 Years
65 Years
Not Enrolling
Hepatitis B, Chronic

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

plasma levels of endotoxin

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Gao Zhiliang, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

The Third Affliated Hospital of Sun Yat-sen University


China: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

March 2010

Related Keywords:

  • Hepatitis B, Chronic
  • endotoxaemia
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Hepatitis, Chronic
  • Endotoxemia
  • Hepatitis B, Chronic