Alcoholic HepatitisAHILNCT01918462
Protective Immune Mechanisms in Alcoholic Hepatitis
An observational study of Alcoholic Hepatitis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the production, effects and interactions of the hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholic Hepatitis
- How many people
- 51 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to 20 Apr 2018
- 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 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted to the Department of hepatology and gastroenterology V, Aarhus University hospital
Who may be able to join
- Diagnosis of alcoholic hepatitis:
- relevant history of alcohol consumption (>40g/day for a minimum of 6 months with cessation of consumption no earlier than 3 months prior to admission)
- bilirubin > 80 mol/l
- neutrophil granulocytes > 10x10^9/L
- exclusion of other liver pathology including biliary disease
- histological verification on liver biopsy
- Written, informed consent
Who cannot join
- Other chronic inflammatory or autoimmune diseases
- Severe, acute bacterial infection (peritonitis, sepsis, pneumonia, urinary tract infection etc.)
- Cancer
- Prednisolon or pentoxifylline treatment within the past 8 weeks
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Hepatology and gastroenterology V, Aarhus university hospital
Aarhus, 8000
About this study
The purpose of this study is to investigate the production, effects and interactions of the hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis.
Read the detailed description
The investigators will study hepatic biopsies from patients with alcoholic hepatitis. In these biopsies, the investigators will assess the production of IL-22 and which cells produce the cytokine. The investigators will study the expression of the IL-22 receptor and also the production of the IL-22 binding protein, which can inhibit the actions of the cytokine.
- Conditions
- Alcoholic Hepatitis
- Keywords
- Alcoholic hepatitis, IL-22, Kupffer cells
- Medical subject headings
- Hepatitis, Alcoholic
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 |
|---|---|---|
| Alcoholic hepatitis | Patients with alcoholic hepatic; cases. | |
| Healthy controls | Persons undergoing hepatic resection; controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of IL-22-producing cells
This will be detected in hepatic biopsies taken at inclusion to the study.
Measured: at day 1 ( the day of diagnosis/arrival to the department)
Secondary outcomes (3)
IL-22 binding protein
This will be detected in hepatic biopsies taken at inclusion to the study.
Measured: at day 1 ( the day of diagnosis/arrival to the department)
IL-22 receptor
This will be detected in hepatic biopsies taken at inclusion to the study.
Measured: at day 1 ( the day of diagnosis/arrival to the department)
Signalling molecules and markers of hepatocyte destruction
Thse measurements will be done on blood samples drawn at inclusion, at day 7 and at day 90 after diagnosis.
Measured: at day 1, at day 7 and at day 90 after diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startApr 2013
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidsel Støy, Phd student, Principal investigator, Department of hepatology and gastroenterology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918462
- Sponsor's protocol ID
- AHIL
- Other IDs
- AUH
- Acronym
- AHIL
- Status last verified
- Oct 2018
- First submitted
- 25 Jun 2013
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Immune Mechanisms in Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT01918462
- Acronym / sponsor ID
- AHIL / AHIL
- Conditions
- Alcoholic Hepatitis
- Keywords
- Alcoholic hepatitis, IL-22, Kupffer cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 7 Aug 2013 (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 purpose of this study is to investigate the production, effects and interactions of the hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis.
Detailed description
The investigators will study hepatic biopsies from patients with alcoholic hepatitis. In these biopsies, the investigators will assess the production of IL-22 and which cells produce the cytokine. The investigators will study the expression of the IL-22 receptor and also the production of the IL-22 binding protein, which can inhibit the actions of the cytokine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcoholic hepatitis | – | –Patients with alcoholic hepatic; cases. |
| Healthy controls | – | –Persons undergoing hepatic resection; controls. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Department of hepatology and gastroenterology V, Aarhus University hospital
Key inclusion criteria (7 listed)
- Diagnosis of alcoholic hepatitis:
- relevant history of alcohol consumption (>40g/day for a minimum of 6 months with cessation of consumption no earlier than 3 months prior to admission)
- bilirubin > 80 mol/l
- neutrophil granulocytes > 10x10^9/L
- exclusion of other liver pathology including biliary disease
Key exclusion criteria (5 listed)
- Other chronic inflammatory or autoimmune diseases
- Severe, acute bacterial infection (peritonitis, sepsis, pneumonia, urinary tract infection etc.)
- Cancer
- Prednisolon or pentoxifylline treatment within the past 8 weeks
- Pregnancy
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
Frequency of IL-22-producing cells
Time frame: at day 1 ( the day of diagnosis/arrival to the department)
This will be detected in hepatic biopsies taken at inclusion to the study.
3 secondary outcomes
IL-22 binding protein
Time frame: at day 1 ( the day of diagnosis/arrival to the department)
IL-22 receptor
Time frame: at day 1 ( the day of diagnosis/arrival to the department)
Signalling molecules and markers of hepatocyte destruction
Time frame: at day 1, at day 7 and at day 90 after diagnosis.
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 29 Apr 2021.
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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.
Sidsel Støy, Phd student principal investigator
Department of hepatology and gastroenterology, Aarhus University Hospital
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 Hepatitis, run by University of Aarhus at 1 site in Denmark.
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 7 inclusion and 5 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 29 Apr 2021. 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 Denmark. 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?
Frequency of IL-22-producing cells (time frame: at day 1 ( the day of diagnosis/arrival to the department)). 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 29 Apr 2021.