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

This study focuses on alcoholic liver disease, especially a severe form called alcoholic hepatitis. This condition can be very serious, and doctors want to learn more about how common it is and how it affects people over time. Researchers are collecting information and genetic samples from patients admitted for jaundice to build a better picture of the disease. They aim to understand how inflammation and the body's ability to repair itself play a role. The study will also explore new ways to diagnose alcoholic hepatitis without invasive procedures. This research hopes to improve our understanding and treatment of alcohol-related liver conditions, ultimately helping people affected by these diseases.

At a glance

Status
Recruiting
Sponsor
University Hospital, Lille
Enrolment target
447
Start
23 Oct 2019
Estimated completion
01 Apr 2027

What is this study about?

This research study is looking into liver diseases caused by drinking alcohol, particularly a serious condition called alcoholic hepatitis. When someone has severe alcoholic hepatitis, it can be very dangerous in the short term. Doctors want to understand why some people get this condition and how to help them.

The study aims to find out how common alcoholic hepatitis is among people who are admitted to the hospital with jaundice (yellowing of the skin and eyes). They will also follow these patients to see how their condition develops over time, checking things like how long they live and how well their liver is working. To do this, they will collect blood samples, which will include genetic information, to create a special collection called a biobank. This will help them learn about the body's response, like inflammation and how the liver tries to heal itself.

Ultimately, this study wants to improve how we diagnose and understand alcohol-related liver diseases. They are also looking at less invasive ways to diagnose these conditions, meaning tests that don't involve procedures like a liver biopsy. The goal is to gather vital information that can lead to better care and treatments for patients in the future.

Key takeaways

  • This study aims to understand severe alcohol-related liver disease.
  • It's an observational study, meaning no new treatments are given.
  • Researchers will collect genetic samples to help understand the disease.
  • The goal is to improve diagnosis and future treatments.
  • It focuses on patients with alcoholic hepatitis and liver scarring.

Who may be eligible?

To be considered for this study, you would generally need to have a history of regularly drinking a certain amount of alcohol over several years. Specifically, this means more than 40 grams of alcohol per day for women and more than 50 grams per day for men, for over five years.

If you have severe alcoholic hepatitis, you would also need to have experienced jaundice recently (within the last three months) and have a certain level of bilirubin (a substance measured in your blood). If you have less severe alcoholic hepatitis, the main requirements are the drinking history mentioned above.

People with severe liver scarring (cirrhosis) caused by alcohol are also included if they meet the alcohol consumption criteria and show clear signs of cirrhosis through examinations, scans, or blood tests. However, you cannot join the study if you have other liver diseases (like viral hepatitis or Wilson's disease), liver cancer, or HIV.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I have been drinking alcohol regularly for more than 5 years.
  2. For women, I usually drink more than 40 grams of alcohol per day; for men, more than 50 grams per day.
  3. I have recently had yellow skin or eyes (jaundice).
  4. I do not have other main liver diseases (like Hepatitis B or C).
  5. I do not have liver cancer or HIV.
Answer every question to see your result.

What does participation involve?

This study is observational, which means you won't be given any new medications or treatments as part of it. Instead, the researchers will collect information and samples from you. This will involve assessing your survival and how well your liver is functioning. They will also collect blood samples to create a biobank, which is like a library of genetic material. The study will involve regular follow-up to track your health progress, and while the exact duration isn't specified, observational studies often involve checking in over several months or years. The researchers will also look at how well non-invasive tests can diagnose your condition.

Potential risks and benefits

Participating in this study might help advance our overall understanding of alcoholic liver disease, which could lead to better diagnoses and treatments for others in the future. The risks primarily involve the usual discomfort of blood draws, and there are no new medications or treatments given. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (9)

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

Common questions

What is 'alcoholic hepatitis'?

It's a serious liver condition caused by heavy alcohol use that can lead to inflammation and damage to the liver.

What does 'observational study' mean?

It means researchers will watch and collect information about your condition without asking you to change your specific medical treatments or routines.

What is a 'biobank'?

It's a collection of biological samples, like blood, that researchers can use to study genetics and other factors related to a disease.

Will I receive new medicine in this study?

No, this study does not involve giving new medicines. It focuses on observing and collecting information about your condition.

Who is funding this research?

The information provided does not specify the funding source for this particular study.

How to find out more

Alexandre Louvet, MD,PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study of Genetic Determinants in Alcoholic Hepatitis and Est…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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