Liver DiseasesTargetOHNCT03773887
Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
A study testing collection of liver biopsies collection of blood samples in people with Liver Diseases and Acute on Chronic Hepatic Failure, run by University Hospital, Lille at 1 site in France.
Trial summary
The main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic liver disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Diseases, Acute on Chronic Hepatic Failure
- What is being tested?
- collection of liver biopsies collection of blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 25 Dec 2014to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- group A: patients with acute alcoholic hepatitis
- Active alcohol abuse defined by DSM IV and excessive alcohol consumption prior to admission (> 60 g per day for men and> 40 g per day for women)
- Moderate elevation of transaminases (less than 500 U / L) with a typical ASAT / ALAT ratio of 2: 1
- Bilirubin> 50 mg / l
- Absence of autoimmune liver disease (ANA <1/80, AML <1/80, LKM1 neg, AAM neg)
- Absence of hepatitis B and C and HIV infection (negative anti-HIV antibodies, negative HBsAg, negative HCV PCR)
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- Patients with other acute complications than alcoholic hepatitis may be included (eg, digestive hemorrhage, acute renal failure, infection, etc.)
- Because there is no validated noninvasive tool for the diagnosis of alcoholic hepatitis, histological confirmation is required in all patients (preferably by transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histological characteristics: Hepatocellular lesions (ballooning, Mallory body)/ Inflammatory infiltrate with polymorphonuclear neutrophils
- group B1: patients with alcoholic cirrhosis
- Decompensated or non-decompensated alcoholic cirrhosis, defined according to the HAS guidelines, ie by a liver biopsy or a cluster of clinico-biological arguments (www.has-sante.fr)
- group B2: patients free from chronic liver disease
- Justification of blood and liver sampling for the management of a pathology other than chronic liver disease (eg liver metastasis of digestive cancer occurring on healthy liver)
Who cannot join
- For groups A and B1:
- Patients with hepatocellular carcinoma of progressive non-hepatic cancer
- Presence of HBsAg
- Presence of anti-HCV antibodies by positive PCR
- Presence of antibodies to HIV 1 +2
- Pregnancy
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- for group B2:
- Alcoholic liver disease
- Presence of HBsAg
- Presence of anti-HCV antibodies by positive PCR
- Presence of antibodies to HIV 1 +2
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Claude Huriez, CHRU
Lille
Philippe Mathruin, MD,PhD
Alexandre Louvet, MD,PhD
About this study
The main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic liver disease
- Conditions
- Liver Diseases, Acute on Chronic Hepatic Failure
- Being tested
- collection of liver biopsies collection of blood samples
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of liver biopsies collection of blood samplesOther
blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies
| Study group | Role | What they receive |
|---|---|---|
| acute alcoholic hepatitis | Other | collection of liver biopsies collection of blood samples in patients with acute alcoholic hepatitis (group A) Receives: Other: collection of liver biopsies collection of blood samples |
| Alcoholic cirrhosis | Other | collection of liver biopsies collection of blood samples in patients with alcoholic cirrhosis (group B1) Receives: Other: collection of liver biopsies collection of blood samples |
| Without chronic liver disease | Other | collection of liver biopsies collection of blood samples in patients without chronic liver disease (group B2) Receives: Other: collection of liver biopsies collection of blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
the expression of proinflammatory cytokines
Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)
Measured: Baseline
Secondary outcomes (3)
the expression of genetic variants of pro-inflammatory cytokines
Identification of genetic variants of pro-inflammatory cytokines that contribute to mortality of Alcoholic Liver Disease
Measured: Baseline
Cell lysis (AST, ALT, CK18 cleaved)
Measured: Baseline
Regeneration markers (Ki-67, Fn14, CK7)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start25 Dec 2014
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philppe Mathurin, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773887
- Sponsor's protocol ID
- 2014_30
- Other IDs
- 2014-A01452-45
- Acronym
- TargetOH
- Status last verified
- May 2026
- First submitted
- 16 Oct 2018
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
- ClinicalTrials.gov ID
- NCT03773887
- Acronym / sponsor ID
- TargetOH / 2014_30
- Conditions
- Liver Diseases, Acute on Chronic Hepatic Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 25 Dec 2014 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Dec 2018 (actual)
- 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 main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic liver disease
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acute alcoholic hepatitis | Other | Other: collection of liver biopsies collection of blood samplescollection of liver biopsies collection of blood samples in patients with acute alcoholic hepatitis (group A) |
| Alcoholic cirrhosis | Other | Other: collection of liver biopsies collection of blood samplescollection of liver biopsies collection of blood samples in patients with alcoholic cirrhosis (group B1) |
| Without chronic liver disease | Other | Other: collection of liver biopsies collection of blood samplescollection of liver biopsies collection of blood samples in patients without chronic liver disease (group B2) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- group A: patients with acute alcoholic hepatitis
- Active alcohol abuse defined by DSM IV and excessive alcohol consumption prior to admission (> 60 g per day for men and> 40 g per day for women)
- Moderate elevation of transaminases (less than 500 U / L) with a typical ASAT / ALAT ratio of 2: 1
- Bilirubin> 50 mg / l
- Absence of autoimmune liver disease (ANA <1/80, AML <1/80, LKM1 neg, AAM neg)
Key exclusion criteria (12 listed)
- For groups A and B1:
- Patients with hepatocellular carcinoma of progressive non-hepatic cancer
- Presence of HBsAg
- Presence of anti-HCV antibodies by positive PCR
- Presence of antibodies to HIV 1 +2
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 |
|---|---|---|
| collection of liver biopsies collection of blood samplesblood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies | Other | Alcoholic cirrhosis, Without chronic liver disease, acute alcoholic hepatitis |
Primary outcome
the expression of proinflammatory cytokines
Time frame: Baseline
Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)
3 secondary outcomes
the expression of genetic variants of pro-inflammatory cytokines
Time frame: Baseline
Cell lysis (AST, ALT, CK18 cleaved)
Time frame: Baseline
Regeneration markers (Ki-67, Fn14, CK7)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Philppe Mathurin, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collection of liver biopsies collection of blood samples in people with Liver Diseases and Acute on Chronic Hepatic Failure, run by University Hospital, Lille at 1 site in France.
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 12 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Mathurin, MD,PhD (03 20 44 55 97 ext. +33, philippe.mathurin@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the expression of proinflammatory cytokines (time frame: Baseline). 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 22 May 2026.