Chronic Liver DiseaseNCT00629668
Genetic Polymorphisms of TNF-α Promoter and HBV Genotype on Outcome of HBV-Related Chronic Liver Disease
A study testing TNF-alpha and HBV genotype and TNF-alpha and HBV genotypes in people with Chronic Liver Disease and Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The prognosis of Hepatitis B virus (HBV)infection varies from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma (HCC).Both viral and host genetic factors contribute to disease severity. Cytokine gene polymorphism has been regarded affecting prognosis of disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Liver Disease, Hepatocellular Carcinoma
- What is being tested?
- TNF-alpha and HBV genotype and TNF-alpha and HBV genotypes
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Jan 2007to Dec 2007
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- HBV-positive patients
Who cannot join
- HBV-negative patients
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 807
Jen-Eing Jeng, M.D., 886-7-3121101 ext. 7223, jejeng @cc.kmu.edu.tw
Jen-Eing Jeng, M.D.
About this study
The prognosis of Hepatitis B virus (HBV)infection varies from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma (HCC).Both viral and host genetic factors contribute to disease severity. Cytokine gene polymorphism has been regarded affecting prognosis of disease. By detecting HBV genotyping and tumor necrosis factor-alpha polymorphism, this study aime to assess their effects and interaction on disease severity of HBV-related chronic liver disease and HCC.
- Conditions
- Chronic Liver Disease, Hepatocellular Carcinoma
- Being tested
- TNF-alpha and HBV genotype, TNF-alpha and HBV genotypes
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF-alpha and HBV genotypeGenetic
TNF-alpha and HBV genotypesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokine gene polymorphism
Measured: years
Secondary outcomes (1)
cytokine gene polymorohism on severity of disease
Measured: years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startJan 2007
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Jen-Eing Jeng, M.D., Principal investigator, Assistant Professor of Clinical Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629668
- Sponsor's protocol ID
- KMUH-IRB-940189
- Status last verified
- Jul 2007
- First submitted
- 26 Feb 2008
- Last updated
- 6 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphisms of TNF-α Promoter and HBV Genotype on Outcome of HBV-Related Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT00629668
- Acronym / sponsor ID
- KMUH-IRB-940189
- Conditions
- Chronic Liver Disease, Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 6 Mar 2008 (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.
The prognosis of Hepatitis B virus (HBV)infection varies from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma (HCC).Both viral and host genetic factors contribute to disease severity. Cytokine gene polymorphism has been regarded affecting prognosis of disease. By detecting HBV genotyping and tumor necrosis factor-alpha polymorphism, this study aime to assess their effects and interaction on disease severity of HBV-related chronic liver disease and HCC.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- HBV-positive patients
Key exclusion criteria (1 listed)
- HBV-negative patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNF-alpha and HBV genotype | Genetic | – |
| TNF-alpha and HBV genotypes | Other | – |
Primary outcome
cytokine gene polymorphism
Time frame: years
1 secondary outcome
cytokine gene polymorohism on severity of disease
Time frame: years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2008.
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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.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Jen-Eing Jeng, M.D. principal investigator
Assistant Professor of Clinical Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TNF-alpha and HBV genotype and TNF-alpha and HBV genotypes in people with Chronic Liver Disease and Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Mar 2008. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytokine gene polymorphism (time frame: years). 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 6 Mar 2008.