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Recruiting NCT04106518

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

— Observational Alcoholic Liver Disease Severe Alcoholic Hepatitis Alcoholic Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Alcoholic Liver Disease, Severe Alcoholic Hepatitis, Alcoholic Cirrhosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Prevalence of alcoholic hepatitis in heavy drinkers with jaundice [Time frame: At baseline (time of liver biopsy)]
Secondary outcome measures (7)
  • Survival [Time frame: at 12 months]
  • Change in serum total bilirubin [Time frame: Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months]
  • Change in serum creatinine [Time frame: Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months]
  • Change in MELD (Model for End-stage Liver Disease)score [Time frame: Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months]
  • 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) [Time frame: Baseline, at 7 days, at 30 days and at 12 months]
  • Identification of the genetic profiles of individuals with severe, non-severe and cirrhotic alcoholic hepatitis( blood sample) [Time frame: Baseline]
  • Measurement of diagnostic performance (area under the ROC curve) [Time frame: At baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 9 centers
  • Chr Angers — Angers
  • Chru Besancon — Besançon
  • Hôpital Jean Verdier, AH-HP — Bondy
  • Centre Hospitalier Universitaire — Caen
  • Hopital Nord - Chu38 - La Tronche — La Tronche
  • Hôpital Claude Huriez, CHU — Lille
  • Association Hopital Saint Joseph - Marseille — Marseille
  • Chu Montpellier — Montpellier
  • … and 1 more center

Identifiers

NCT: NCT04106518 · 2017_51 · 2018-A02286-49

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗