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

This study has been completed.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01107483
First received: April 16, 2010
Last updated: May 6, 2010
Last verified: January 2010
History of Changes
  Purpose

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).


Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic HBV Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • plasma levels of endotoxin [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum albumin level [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Plasma cytokine concentration [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    ELISA 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) level [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • serum high density lipoprotein (HDL) level [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • plasma sCD14 level [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    ELISA kits were used to assess in duplicate the plasma concentrations of soluble CD14 (sCD14) (R&D Systems, Minneapolis, MN).


Enrollment: 140
Study Start Date: December 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
AC group
asymptomatic carriers
CH group
patients with chronic hepatitis
HC group
patients with hepatic cirrhosis
ACLF group
patients with acute on chronic liver failure
healthy control
healthy volunteers

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.
  Eligibility

Ages Eligible for Study:   24 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients with chronic HBV infection admitted to The Third Affliated Hospital of Sun Yat-sen University

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107483

Locations
China, Guangdong
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Gao Zhiliang, Professor The Third Affliated Hospital of Sun Yat-sen University
  More Information

No publications provided

Responsible Party: The Third Affliated Hospital of Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01107483     History of Changes
Other Study ID Numbers: endotoxaemiaobservation
Study First Received: April 16, 2010
Last Updated: May 6, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
endotoxaemia

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Endotoxemia
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013