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Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease

NCT ID: NCT04106518

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

447 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-23

Study Completion Date

2025-04-30

Brief Summary

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Alcoholic hepatitis carries a risk of high mortality at short term, especially in its severe form. Its diagnosis is confirmed by liver biopsy. The prevalence of alcoholic hepatitis, severe or not severe, is poorly known and prospective data are needed. The present observational study aims to define the prevalence of alcoholic hepatitis among patients admitted for jaundice and determine their outcome according to the severity. Survival and markers of liver dysfunction will be assessed. A biobank including genetic samples will be created to identify the disease profile in terms of inflammation and regeneration. The performance of non-invasive criteria for diagnosis will also be studied.

Detailed Description

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Conditions

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Alcoholic Liver Disease Severe Alcoholic Hepatitis Alcoholic Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cirrhosis

Patients with alcoholic liver disease without alcoholic hepatitis

No interventions assigned to this group

severe alcoholic hepatitis

Patients with severe alcoholic hepatitis ( Maddrey score ≥32)

No interventions assigned to this group

non-severe alcoholic hepatitis

Patients with non-severe alcoholic hepatitis (Maddrey score \<32)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

For SAH group:

* Alcohol consumption :

* On average\> 40 g / day for women and 50 g / day for men
* Duration:\> 5 years
* Recent jaundice episode (less than 3 months)
* Bilirubin\> 50 mg / l (85μmol / l)

For NSAH group:

\- Alcohol consumption :

* On average\> 40 g / day for women and 50 g / day for men
* Duration:\> 5 years

For cirrhosis (control) group:

* Alcohol consumption :

* On average\> 40 g / day for women and 50 g / day for men
* Duration:\> 5 years
* Unambiguous presence of cirrhosis criteria, including:

* clinical signs (ascites, stellar angiomas ...) and / or
* radiological signs (scanner or MRI: signs of hepatic dysmorphism and / or portal hypertension) and / or
* biological signs (increased INR, thrombocytopenia) and / or
* endoscopic signs (oesophageal / gastric varices)

Exclusion Criteria

For NAH and NSAH groups:

* Presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)
* Presence of hepatocellular carcinoma
* HIV infection

For cirrhosis (control) group:

* History established / suggestive of HAA (Clinical, biological and / or histological criteria) in particular absence of jaundice episode
* Presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)
* Presence of hepatocellular carcinoma
* HIV infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre Louvet, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Chr Angers

Angers, , France

Site Status RECRUITING

Chru Besancon

Besançon, , France

Site Status RECRUITING

Hôpital Jean Verdier, AH-HP

Bondy, , France

Site Status RECRUITING

Centre Hospitalier Universitaire

Caen, , France

Site Status RECRUITING

Hopital Nord - Chu38 - La Tronche

La Tronche, , France

Site Status RECRUITING

Hôpital Claude Huriez, CHU

Lille, , France

Site Status RECRUITING

Association Hopital Saint Joseph - Marseille

Marseille, , France

Site Status RECRUITING

Chu Montpellier

Montpellier, , France

Site Status RECRUITING

Hu Est Parisien Site St Antoine Aphp - Paris 12

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Alexandre Louvet, MD,PhD

Role: CONTACT

[email protected]
03 20 44 55 97 ext. +33

Other Identifiers

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2018-A02286-49

Identifier Type: OTHER

Identifier Source: secondary_id

2017_51

Identifier Type: -

Identifier Source: org_study_id