Alcoholic HepatitisHeliacNCT00992888
Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis
A study testing Prometheus Liver Dialysis system (Fresenius Medical Care) in people with Alcoholic Hepatitis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the role of endotoxins and the endotoxin mediated immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect of Liver assist (liver dialyses) intervention on these parameters in patients with severe alcoholic hepatitis. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Prometheus Liver Dialysis system (Fresenius Medical Care)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Sep 2011
- 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with alcoholic hepatitis based on the following criteria
- Alcohol intake for 6 consecutive months above 40g /day, at admission or 3 months earlier.
- Serum bilirubin level above 80 mmol/l
Who cannot join
- Liver biopsy when diagnosis is unclear.
- Heart failure
- Pregnancy
- non fluent danish speakers
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medicine V, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis. A Pato-etiological Study With Focus on the Endotoxin Pathway.
The purpose of this study is to investigate the role of endotoxins and the endotoxin mediated immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect of Liver assist (liver dialyses) intervention on these parameters in patients with severe alcoholic hepatitis.
- Conditions
- Alcoholic Hepatitis
- Being tested
- Prometheus Liver Dialysis system (Fresenius Medical Care)
- Keywords
- Alcoholic Hepatitis, Alcohol, Endotoxin, LPS, Liver dialysis, Innate immunity, Toll Like receptors
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prometheus Liver Dialysis system (Fresenius Medical Care)Device
Also called The prometheus albumin dialysis by Fresenius Medical Care
6 hour dialysis for 3 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| albumin liver dialysis | Experimental | Not described Receives: Device: Prometheus Liver Dialysis system (Fresenius Medical Care) |
| Standard medial care without dialysis | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum endotoxin levels
Measured: one year
Secondary outcomes (1)
Endotoxin activation pathway proteins
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionSep 2011
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Damgaard Sandahl, University of Aarhus
- Investigators
- Hendrik Vilstrup, Prof, Study director, Department of Medicine V, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992888
- Sponsor's protocol ID
- Heliac-01
- Acronym
- Heliac
- Status last verified
- Sep 2011
- First submitted
- 8 Oct 2009
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stoy S, Dige A, Sandahl TD, Laursen TL, Buus C, Hokland M, Vilstrup H. Cytotoxic T lymphocytes and natural killer cells display impaired cytotoxic functions and reduced activation in patients with alcoholic hepatitis. Am J Physiol Gastrointest Liver Physiol. 2015 Feb 15;308(4):G269-76. doi: 10.1152/ajpgi.00200.2014. Epub 2014 Dec 11.
PubMed 25501547
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis. A Pato-etiological Study With Focus on the Endotoxin Pathway.
- ClinicalTrials.gov ID
- NCT00992888
- Acronym / sponsor ID
- Heliac / Heliac-01
- Conditions
- Alcoholic Hepatitis
- Keywords
- Alcoholic Hepatitis, Alcohol, Endotoxin, LPS, Liver dialysis, Innate immunity, Toll Like receptors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 Oct 2009 (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 role of endotoxins and the endotoxin mediated immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect of Liver assist (liver dialyses) intervention on these parameters in patients with severe alcoholic hepatitis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| albumin liver dialysis | Experimental | Device: Prometheus Liver Dialysis system (Fresenius Medical Care) |
| Standard medial care without dialysis | No intervention | – |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with alcoholic hepatitis based on the following criteria
- Alcohol intake for 6 consecutive months above 40g /day, at admission or 3 months earlier.
- Serum bilirubin level above 80 mmol/l
Key exclusion criteria (4 listed)
- Liver biopsy when diagnosis is unclear.
- Heart failure
- Pregnancy
- non fluent danish speakers
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 |
|---|---|---|
| Prometheus Liver Dialysis system (Fresenius Medical Care)Also: The prometheus albumin dialysis by Fresenius Medical Care6 hour dialysis for 3 consecutive days | Device | albumin liver dialysis |
Primary outcome
Serum endotoxin levels
Time frame: one year
1 secondary outcome
Endotoxin activation pathway proteins
Time frame: 1 year
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 15 Sep 2011.
- Derived from this study: PubMed 25501547Stoy S, Dige A, Sandahl TD, Laursen TL, Buus C, Hokland M, Vilstrup H. Cytotoxic T lymphocytes and natural killer cells display impaired cytotoxic functions and reduced activation in patients with alcoholic hepatitis. Am J Physiol Gastrointest Liver Physiol. 2015 Feb 15;308(4):G269-76. doi: 10.1152/ajpgi.00200.2014. Epub 2014 Dec 11.
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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.
Hendrik Vilstrup, Prof study director
Department of Medicine V, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prometheus Liver Dialysis system (Fresenius Medical Care) in people with 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 3 inclusion and 4 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 15 Sep 2011. 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?
Serum endotoxin levels (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00992888, 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 15 Sep 2011.