Understanding genetic factors in alcoholic liver disease
Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
This study looks at how common alcoholic hepatitis is in people with jaundice and tries to understand the role of genetics in the disease while also testing new ways to diagnose it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 447 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 9 sites (Angers and 8 other locations) |
| Trial ID | NCT04106518 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence of alcoholic hepatitis among patients with jaundice and evaluate their outcomes based on disease severity. It will involve collecting data on liver dysfunction and survival rates, while also creating a biobank for genetic samples to explore the disease's inflammatory and regenerative profiles. Additionally, the study will investigate the effectiveness of non-invasive diagnostic criteria for alcoholic hepatitis. The research will be conducted across multiple centers to gather a diverse cohort of patients.
Who should consider this trial
Good fit: Ideal candidates include individuals with a history of significant alcohol consumption and recent jaundice, as well as those diagnosed with alcoholic cirrhosis.
Not a fit: Patients with other liver pathologies or those who do not meet the alcohol consumption criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of alcoholic liver disease, potentially enhancing patient outcomes.
How similar studies have performed: While this study builds on existing knowledge, the specific approach of creating a multicenter cohort with a genetic focus is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers and 8 other locations
- Chr Angers — Angers, France (Recruiting)
- Chru Besancon — Besançon, France (Recruiting)
- Hôpital Jean Verdier, AH-HP — Bondy, France (Recruiting)
- Centre Hospitalier Universitaire — Caen, France (Recruiting)
- Hopital Nord - Chu38 - La Tronche — La Tronche, France (Recruiting)
- Hôpital Claude Huriez, CHU — Lille, France (Recruiting)
- Association Hopital Saint Joseph - Marseille — Marseille, France (Recruiting)
- Chu Montpellier — Montpellier, France (Recruiting)
- Hu Est Parisien Site St Antoine Aphp - Paris 12 — Paris, France (Recruiting)
Study contacts
- Principal investigator: Alexandre Louvet, MD,PhD — University Hospital, Lille
- Study coordinator: Alexandre Louvet, MD,PhD
- Email: alexandre.louvet@chru-lille.fr
- Phone: 03 20 44 55 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.