Hepatitis BNCT00629486
Genetic Polymorphisms of Interleukin-1B and TNF-A and HBV-Related Hepatocellular Carcinoma
A study testing Polymorphism of IL-1 beta and TNF-alpha in people with Hepatitis B and Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 2 sites in Taiwan.
Trial summary
By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Hepatocellular Carcinoma, Chronic Liver Disease
- What is being tested?
- Polymorphism of IL-1 beta and TNF-alpha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2007to May 2008
- 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
- HBsAg-positive patients
Who cannot join
- HBsAg-negative patients
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Medical University Chung-Ho Hospital
Kaohsiung City, Kaohsiung, 807
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 807
About this study
By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.
Read the detailed description
Hepatitis B virus (HBV)infection is the major risk factor for chronic liver disease and hepatocellular carcinoma (HCC). Host immunogenetic factors contribute to HBV-associated liver damage and/or carcinogenesis. Variant cytokine alleles, including tumor necrosis factor-α(TNF-α)and interleukin-1β(IL-1β), might contribute to interindividual difference in inflammatory responses and account for heterogeneous disease outcome of infectious disease.
By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.
- Conditions
- Hepatitis B, Hepatocellular Carcinoma, Chronic Liver Disease
- Being tested
- Polymorphism of IL-1 beta and TNF-alpha
- Keywords
- cytokine gene, hepatitis B, hepatocellular carcinoma, chronic liver disease
- Medical subject headings
- Hepatitis B, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymorphism of IL-1 beta and TNF-alphaGenetic
Also called polymorphism, TNF-alpha, interleukin-1L
To analyze the role of polymorphisms of IL-1beta and TNF-alpha gene on risk of hepatitis B-related chronic liver disease and hepatocellular carcinoma
| Study group | Role | What they receive |
|---|---|---|
| cytokines were determined | Experimental | prevalence of genetic polymorphisms of interleukin 1B was measured in HBV-related hepatocellular carcinoma Receives: Genetic: Polymorphism of IL-1 beta and TNF-alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokine polymorphisms increase risk for hepatocellular carcinoma
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
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Fa,Tsai, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Jung-Fa Tsai, M.D., Ph.D., Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629486
- Sponsor's protocol ID
- KMUH-IRB-950181
- Status last verified
- Apr 2013
- First submitted
- 26 Feb 2008
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphisms of Interleukin-1B and TNF-A and HBV-Related Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00629486
- Acronym / sponsor ID
- KMUH-IRB-950181
- Conditions
- Hepatitis B, Hepatocellular Carcinoma, Chronic Liver Disease
- Keywords
- cytokine gene, hepatitis B, hepatocellular carcinoma, chronic liver disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- 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.
By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.
Detailed description
Hepatitis B virus (HBV)infection is the major risk factor for chronic liver disease and hepatocellular carcinoma (HCC). Host immunogenetic factors contribute to HBV-associated liver damage and/or carcinogenesis. Variant cytokine alleles, including tumor necrosis factor-α(TNF-α)and interleukin-1β(IL-1β), might contribute to interindividual difference in inflammatory responses and account for heterogeneous disease outcome of infectious disease.
By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cytokines were determined | Experimental | Genetic: Polymorphism of IL-1 beta and TNF-alphaprevalence of genetic polymorphisms of interleukin 1B was measured in HBV-related hepatocellular carcinoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- HBsAg-positive patients
Key exclusion criteria (1 listed)
- HBsAg-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 |
|---|---|---|
| Polymorphism of IL-1 beta and TNF-alphaAlso: polymorphism, TNF-alpha, interleukin-1LTo analyze the role of polymorphisms of IL-1beta and TNF-alpha gene on risk of hepatitis B-related chronic liver disease and hepatocellular carcinoma | Genetic | cytokines were determined |
Primary outcome
cytokine polymorphisms increase risk for hepatocellular carcinoma
Time frame: years
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 18 Apr 2013.
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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.
Jung-Fa Tsai, M.D., Ph.D. principal investigator
Professor of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymorphism of IL-1 beta and TNF-alpha in people with Hepatitis B and Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 2 sites 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: finished, as of the sponsor's last update on 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
cytokine polymorphisms increase risk for hepatocellular carcinoma (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 18 Apr 2013.