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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04106518
Other study ID # 2017_51
Secondary ID 2018-A02286-49
Status Recruiting
Phase
First received
Last updated
Start date October 23, 2019
Est. completion date April 2025

Study information

Verified date November 2023
Source University Hospital, Lille
Contact Alexandre Louvet, MD,PhD
Phone 03 20 44 55 97
Email alexandre.louvet@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 447
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
France Chr Angers Angers
France Chru Besancon Besançon
France Hôpital Jean Verdier, AH-HP Bondy
France Centre Hospitalier Universitaire Caen
France Hopital Nord - Chu38 - La Tronche La Tronche
France Hôpital Claude Huriez, CHU Lille
France Association Hopital Saint Joseph - Marseille Marseille
France Chu Montpellier Montpellier
France Hu Est Parisien Site St Antoine Aphp - Paris 12 Paris

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of alcoholic hepatitis in heavy drinkers with jaundice Assess the prevalence of biopsy-proven alcoholic hepatitis in a cohort of heavy drinkers admitted with recent jaundice At baseline (time of liver biopsy)
Secondary Survival Survival rate at 12 months at 12 months
Secondary Change in serum total bilirubin Total bilirubin is a liver parameter, used for the biological liver test evaluation, measured in mg/dl in the serum Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
Secondary Change in serum creatinine Creatinine is a marker of kidney function, assessed in the blood and measured in milligrams per deciliter Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
Secondary Change in MELD (Model for End-stage Liver Disease)score The MELD score is a validated tool based on INR, creatinine and bilirubin measured in the blood with the following formula:(9.57 × log creatinine in milligrams per deciliter) + (3.78 × log bilirubin in milligrams per deciliter) + (11.20 × log international normalized ratio) + 6.43. The MELD score is used in liver disorders to assess the degree of liver failure. It has no unit. Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
Secondary 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) Serum and plasma evaluation of translational markers (e.g. cytokines) associated with inflammation in patients with alcohol-related liver disease. The list of markers which will be assessed cannot be determined at present and will depend on other ongoing studies performed in alcoholic hepatitis. Baseline, at 7 days, at 30 days and at 12 months
Secondary Identification of the genetic profiles of individuals with severe, non-severe and cirrhotic alcoholic hepatitis( blood sample) Evaluation of genetic markers associated with alcoholic hepatitis as compared to patients with alcohol-related liver disease without alcoholic hepatitis. We will use a non a priori approach as recommended in genetic studies. Thus, the list of genetic markers cannot be provided at that time. Baseline
Secondary Measurement of diagnostic performance (area under the ROC curve) Measurement of diagnostic performance (area under the ROC curve) of the simple and non-invasive clinical and biological criteria for alcoholic hepatitis proposed in an international expert opinion At baseline
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