FibrosisNCT00629603
Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease
A study testing cytokine, cytokine polymorphisms and cytokine polymorphism in people with Fibrosis and Chronic Liver Disease, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 2 sites in Taiwan.
Trial summary
Hepatitis C virus (HCV) infection causes different disease spectrum ranging from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma. Evidence indicates that host genetic factor may play a role in determining disease progression. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fibrosis, Chronic Liver Disease
- What is being tested?
- cytokine, cytokine polymorphisms and cytokine polymorphism
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2007to Sep 2009
- 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
- Patients with anti-HCV positive
Who cannot join
- Anti-HCV-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
Hepatitis C virus (HCV) infection causes different disease spectrum ranging from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma. Evidence indicates that host genetic factor may play a role in determining disease progression. It is known that many cytokine polymorphisms affect disease progressin via increasing hepatic fibrosis that are key factors in progressing liver injury. By combinations of fibrosis-relating gene polymorphisms, this study aims to identify patients with high risk for progressive liver disease. These patients need intensive therapy to decrease morbidity and mortality of chronic HCV-related liver disease.
Read the detailed description
Determination of the following fibrosis-relating gene polymorphisms in HCV-related chronic liver disease and HCC will be performed: TNF-α , TNF-β, Factor V Leiden, TGF-β1, PDGF-B gene, Angiotensinogen (AT),Angiotensin converting enzyme (ACE), microsomal epoxide hydrolase (mEH) and glutathione-S-transferase (GST).
- Conditions
- Fibrosis, Chronic Liver Disease
- Being tested
- cytokine, cytokine polymorphisms, cytokine polymorphism
- Keywords
- hepatitis C virus infection, chronic liver disease, fibrosis-related cytokine
- Medical subject headings
- Fibrosis, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytokineGenetic
Also called hepatitis C virus infection, cytokine polymorphism, fibrosis
polymorphisms of fibrosis-relating cytokine were measured to validate the effectiveness of fibrosis in HCV-related chronic liver disease
cytokine polymorphismsGenetic
Also called hepatitis C virus infection, cytokine polymorphism, fibrosis
Fibrosis-relating cytokine polymorphisms in hepatitis C virus-related chronic liver disease were measured to validate the degree of fibrosis
cytokine polymorphismGenetic
Also called hepatitis C virus infection, cytoline polymorphism, fibrosis
fibrosis-relating cytokine polymorphism
| Study group | Role | What they receive |
|---|---|---|
| cytokine polymorphisms, HCV infection | Experimental | Relate the fibrosis cytokine gene polymorphisms with disease severity of HCV-related chronic liver disease Receives: Genetic: cytokine; Genetic: cytokine polymorphisms; Genetic: cytokine polymorphism |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokine gene polymorphism on disease severity
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 completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosisStudies 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
- 600 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Fa,Tsai (1), 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
- NCT00629603
- Sponsor's protocol ID
- KMUH-IRB-950347
- 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
- Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT00629603
- Acronym / sponsor ID
- KMUH-IRB-950347
- Conditions
- Fibrosis, Chronic Liver Disease
- Keywords
- hepatitis C virus infection, chronic liver disease, fibrosis-related cytokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (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.
Hepatitis C virus (HCV) infection causes different disease spectrum ranging from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma. Evidence indicates that host genetic factor may play a role in determining disease progression. It is known that many cytokine polymorphisms affect disease progressin via increasing hepatic fibrosis that are key factors in progressing liver injury. By combinations of fibrosis-relating gene polymorphisms, this study aims to identify patients with high risk for progressive liver disease. These patients need intensive therapy to decrease morbidity and mortality of chronic HCV-related liver disease.
Detailed description
Determination of the following fibrosis-relating gene polymorphisms in HCV-related chronic liver disease and HCC will be performed: TNF-α , TNF-β, Factor V Leiden, TGF-β1, PDGF-B gene, Angiotensinogen (AT),Angiotensin converting enzyme (ACE), microsomal epoxide hydrolase (mEH) and glutathione-S-transferase (GST).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cytokine polymorphisms, HCV infection | Experimental | Genetic: cytokine, Genetic: cytokine polymorphisms, Genetic: cytokine polymorphismRelate the fibrosis cytokine gene polymorphisms with disease severity of HCV-related chronic liver disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with anti-HCV positive
Key exclusion criteria (1 listed)
- Anti-HCV-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 |
|---|---|---|
| cytokineAlso: hepatitis C virus infection, cytokine polymorphism, fibrosispolymorphisms of fibrosis-relating cytokine were measured to validate the effectiveness of fibrosis in HCV-related chronic liver disease | Genetic | cytokine polymorphisms, HCV infection |
| cytokine polymorphismsAlso: hepatitis C virus infection, cytokine polymorphism, fibrosisFibrosis-relating cytokine polymorphisms in hepatitis C virus-related chronic liver disease were measured to validate the degree of fibrosis | Genetic | cytokine polymorphisms, HCV infection |
| cytokine polymorphismAlso: hepatitis C virus infection, cytoline polymorphism, fibrosisfibrosis-relating cytokine polymorphism | Genetic | cytokine polymorphisms, HCV infection |
Primary outcome
cytokine gene polymorphism on disease severity
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 cytokine, cytokine polymorphisms and cytokine polymorphism in people with Fibrosis and Chronic Liver Disease, 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 gene polymorphism on disease severity (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.