Alcoholic Liver DiseaseNCT00610597
Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease
An observational study of Alcoholic Liver Disease and Chronic Hepatitis C Virus, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Alcoholic liver disease is characterized by circulating T cell activation and liver T cell infiltration but their phenotype is poorly studied. The aim of the study is to test the hypothesis that the (CD4+ T cell secreting Interleukin-17) Th17 pathway is involved in alcoholic liver disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcoholic Liver Disease, Chronic Hepatitis C Virus
- How many people
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2005to Jan 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients of Erasme University Hospital
Who may be able to join
- Alcohol excess intake and suspected liver disease
- Alcohol excess intake and clinical liver cirrhosis
- chronic hepatitis C virus infection and suspected liver disease
- chronic hepatitis C virus infection and clinical liver cirrhosis
Who cannot join
- bacterial or fungal infection
- immunosuppressive treatment
- other causes of liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Alcoholic liver disease is characterized by circulating T cell activation and liver T cell infiltration but their phenotype is poorly studied. The aim of the study is to test the hypothesis that the (CD4+ T cell secreting Interleukin-17) Th17 pathway is involved in alcoholic liver disease.
Read the detailed description
Consecutive patients undergoing transjugular liver biopsies for alcoholic liver disease or hepatitis C virus infection will be included in the study to measure plasma cytokines levels, peripheral blood mononuclear cells cytokine release and liver T cell infiltrates.
- Conditions
- Alcoholic Liver Disease, Chronic Hepatitis C Virus
- Keywords
- liver, alcohol, lymphocyte
- Medical subject headings
- Liver Diseases, Alcoholic, Hepatitis C, Chronic
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 |
|---|---|---|
| 1 | alcoholic liver disease | |
| 2 | chronic hepatitis C virus infection |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startJan 2005
- Primary completionJan 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic Liver DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Arnaud Lemmers, MD, Principal investigator, Erasme Hospital, Gastroenterology Dpt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610597
- Sponsor's protocol ID
- AL-ALD
- Other IDs
- AL-ALD
- Status last verified
- Jan 2008
- First submitted
- 28 Jan 2008
- Last updated
- 8 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Lemmers A, Moreno C, Gustot T, Marechal R, Degre D, Demetter P, de Nadai P, Geerts A, Quertinmont E, Vercruysse V, Le Moine O, Deviere J. The interleukin-17 pathway is involved in human alcoholic liver disease. Hepatology. 2009 Feb;49(2):646-57. doi: 10.1002/hep.22680.
PubMed 19177575
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease
- ClinicalTrials.gov ID
- NCT00610597
- Acronym / sponsor ID
- AL-ALD
- Conditions
- Alcoholic Liver Disease, Chronic Hepatitis C Virus
- Keywords
- liver, alcohol, lymphocyte
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 8 Feb 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.
Alcoholic liver disease is characterized by circulating T cell activation and liver T cell infiltration but their phenotype is poorly studied. The aim of the study is to test the hypothesis that the (CD4+ T cell secreting Interleukin-17) Th17 pathway is involved in alcoholic liver disease.
Detailed description
Consecutive patients undergoing transjugular liver biopsies for alcoholic liver disease or hepatitis C virus infection will be included in the study to measure plasma cytokines levels, peripheral blood mononuclear cells cytokine release and liver T cell infiltrates.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –alcoholic liver disease |
| 2 | – | –chronic hepatitis C virus infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients of Erasme University Hospital
Key inclusion criteria (4 listed)
- Alcohol excess intake and suspected liver disease
- Alcohol excess intake and clinical liver cirrhosis
- chronic hepatitis C virus infection and suspected liver disease
- chronic hepatitis C virus infection and clinical liver cirrhosis
Key exclusion criteria (3 listed)
- bacterial or fungal infection
- immunosuppressive treatment
- other causes of 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
Not reported in the source record.
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 8 Feb 2008.
- Derived from this study: PubMed 19177575Lemmers A, Moreno C, Gustot T, Marechal R, Degre D, Demetter P, de Nadai P, Geerts A, Quertinmont E, Vercruysse V, Le Moine O, Deviere J. The interleukin-17 pathway is involved in human alcoholic liver disease. Hepatology. 2009 Feb;49(2):646-57. doi: 10.1002/hep.22680.
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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.
Arnaud Lemmers, MD principal investigator
Erasme Hospital, Gastroenterology Dpt
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 Alcoholic Liver Disease and Chronic Hepatitis C Virus, run by Erasme University Hospital at 1 site in Belgium.
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 4 inclusion and 3 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 8 Feb 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 Belgium. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00610597, which also lists 1 linked publication.
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 8 Feb 2008.