Hepatitis B, ChronicOCEHBVNCT01107483
Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic Hepatitis B Virus (HBV) Infection
An observational study of Hepatitis B, Chronic, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 24 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with chronic HBV infection admitted to The Third Affliated Hospital of Sun Yat-sen University
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- Parasitic disease of the hepatobiliary system
- Malignancy
- Serious exacerbation of cardiovascular and respiratory system diseases
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic HBV Infection
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).
Read the detailed description
- 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.
- Conditions
- Hepatitis B, Chronic
- Keywords
- endotoxaemia
- Medical subject headings
- Hepatitis B, Chronic, Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma levels of endotoxin
Measured: 4 months
Secondary outcomes (5)
serum albumin level
Measured: 4 months
Plasma cytokine concentration
ELISA kits were used to assess in duplicate the plasma concentrations of IL-6, IL-10, TNFα, and sICAM-1 (Bender, Vienna, Austria).
Measured: 4 months
serum low density lipoprotein (LDL) level
Measured: 4 months
serum high density lipoprotein (HDL) level
Measured: 4 months
plasma sCD14 level
ELISA kits were used to assess in duplicate the plasma concentrations of soluble CD14 (sCD14) (R\&D Systems, Minneapolis, MN).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Gao Zhiliang, Professor, Study chair, The Third Affliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107483
- Sponsor's protocol ID
- endotoxaemiaobservation
- Acronym
- OCEHBV
- Status last verified
- Jan 2010
- First submitted
- 16 Apr 2010
- Last updated
- 7 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic HBV Infection
- ClinicalTrials.gov ID
- NCT01107483
- Acronym / sponsor ID
- OCEHBV / endotoxaemiaobservation
- Conditions
- Hepatitis B, Chronic
- Keywords
- endotoxaemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 24 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic HBV infection admitted to The Third Affliated Hospital of Sun Yat-sen University
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
plasma levels of endotoxin
Time frame: 4 months
5 secondary outcomes
serum albumin level
Time frame: 4 months
Plasma cytokine concentration
Time frame: 4 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gao Zhiliang, Professor study chair
The Third Affliated Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma levels of endotoxin (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2010.