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

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ClinicalTrials.gov Identifier: NCT04106518
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease
Alcoholic Liver Disease Severe Alcoholic Hepatitis Alcoholic Cirrhosis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 447 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Group/Cohort
cirrhosis
Patients with alcoholic liver disease without alcoholic hepatitis
severe alcoholic hepatitis
Patients with severe alcoholic hepatitis ( Maddrey score ≥32)
non-severe alcoholic hepatitis
Patients with non-severe alcoholic hepatitis (Maddrey score <32)



Primary Outcome Measures :
  1. Prevalence of alcoholic hepatitis in heavy drinkers with jaundice [ Time Frame: At baseline (time of liver biopsy) ]
    Assess the prevalence of biopsy-proven alcoholic hepatitis in a cohort of heavy drinkers admitted with recent jaundice


Secondary Outcome Measures :
  1. Survival [ Time Frame: at 12 months ]
    Survival rate at 12 months

  2. Change in serum total bilirubin [ Time Frame: Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months ]
    Total bilirubin is a liver parameter, used for the biological liver test evaluation, measured in mg/dl in the serum

  3. Change in serum creatinine [ Time Frame: Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months ]
    Creatinine is a marker of kidney function, assessed in the blood and measured in milligrams per deciliter

  4. 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 ]
    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.

  5. 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 ]
    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.

  6. Identification of the genetic profiles of individuals with severe, non-severe and cirrhotic alcoholic hepatitis( blood sample) [ Time Frame: Baseline ]
    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.

  7. Measurement of diagnostic performance (area under the ROC curve) [ Time Frame: At baseline ]
    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


Biospecimen Retention:   Samples With DNA
serum, plasma


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106518


Contacts
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Contact: Alexandre Louvet, MD,PhD 03 20 44 55 97 ext +33 alexandre.louvet@chru-lille.fr

Locations
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France
Hôpital Jean Verdier, AH-HP Recruiting
Bondy, France
Centre Hospitalier Universitaire Recruiting
Caen, France
Hôpital Claude Huriez, CHU Recruiting
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Alexandre Louvet, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04106518    
Other Study ID Numbers: 2017_51
2018-A02286-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Cohort
alcoholic hepatitis
alcoholic cirrhosis
pathophysiology
bio bank
pan-genomic study
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Liver Diseases
Hepatitis, Alcoholic
Liver Diseases, Alcoholic
Liver Cirrhosis, Alcoholic
Fibrosis
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Liver Cirrhosis
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders