Viewing Study NCT01107483



Ignite Creation Date: 2024-05-05 @ 10:25 PM
Last Modification Date: 2024-10-26 @ 10:18 AM
Study NCT ID: NCT01107483
Status: COMPLETED
Last Update Posted: 2010-05-07
First Post: 2010-04-16

Brief Title: Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic Hepatitis B Virus HBV Infection
Sponsor: Sun Yat-sen University
Organization: Sun Yat-sen University

Study Overview

Official Title: Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic HBV Infection
Status: COMPLETED
Status Verified Date: 2010-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: OCEHBV
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 manufacturers protocol
3 ELISA ELISA kits were used to assess in duplicate the plasma concentrations of IL-6 IL-10 TNFα sICAM-1 and sCD14

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None