Clinical trial NCT04106518: Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
Official title: Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alcoholic Liver Disease
Severe Alcoholic Hepatitis
Alcoholic Cirrhosis
Keywords: Cohort
alcoholic hepatitis
alcoholic cirrhosis
pathophysiology
bio bank
pan-genomic study
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to jaundice will receive a liver biopsy in accordance with the usual management for diagnosis of alcoholic hepatitis, according to the recommendations of the European Association of Liver Diseases (EASL).

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of alcoholic hepatitis in heavy drinkers with jaundice
timeFrame: At baseline (time of liver biopsy)
Secondary outcomes:
measure: Survival
timeFrame: at 12 months
measure: Change in serum total bilirubin
timeFrame: Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
measure: Change in serum creatinine
timeFrame: Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
measure: Change in MELD (Model for End-stage Liver Disease)score
timeFrame: Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
measure: Identification of inflammatory and biochemical profiles of patients with severe, non-severe and cirrhotic alcoholic hepatitis, based on the constitution of a biobank (serum and plasma)
timeFrame: Baseline, at 7 days, at 30 days and at 12 months
measure: Identification of the genetic profiles of individuals with severe, non-severe and cirrhotic alcoholic hepatitis( blood sample)
timeFrame: Baseline
measure: Measurement of diagnostic performance (area under the ROC curve)
timeFrame: At baseline
Other outcomes:
Locations:
city: Angers
country: France
facility: Chr Angers
city: Besançon
country: France
facility: Chru Besancon
city: Bondy
country: France
facility: Hôpital Jean Verdier, AH-HP
city: Caen
country: France
facility: Centre Hospitalier Universitaire
city: La Tronche
country: France
facility: Hopital Nord - Chu38 - La Tronche
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
city: Marseille
country: France
facility: Association Hopital Saint Joseph - Marseille
city: Montpellier
country: France
facility: Chu Montpellier
city: Paris
country: France
facility: Hu Est Parisien Site St Antoine Aphp - Paris 12
Study officials:
affiliation: University Hospital, Lille
name: Alexandre Louvet, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: