Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic Hepatitis B Virus (HBV) Infection (OCEHBV)
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|ClinicalTrials.gov Identifier: NCT01107483|
Recruitment Status : Completed
First Posted : April 21, 2010
Last Update Posted : May 7, 2010
|Condition or disease|
|Hepatitis B, Chronic|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||140 participants|
|Official Title:||Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic HBV Infection|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||March 2010|
patients with chronic hepatitis
patients with hepatic cirrhosis
patients with acute on chronic liver failure
- plasma levels of endotoxin [ Time Frame: 4 months ]
- serum albumin level [ Time Frame: 4 months ]
- 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).
- serum low density lipoprotein (LDL) level [ Time Frame: 4 months ]
- serum high density lipoprotein (HDL) level [ Time Frame: 4 months ]
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107483
|The Third Affliated Hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510630|
|Study Chair:||Gao Zhiliang, Professor||The Third Affliated Hospital of Sun Yat-sen University|