Information for patients and the public
What is alcohol-related hepatitis?
Alcohol-related hepatitis (AH) is a form of alcohol-related liver disease. It is characterised by liver failure due to recent and heavy alcohol consumption.
How are patients diagnosed with alcohol-related hepatitis?
Liver biopsy is currently the method used to diagnose alcohol-related hepatitis. It is difficult to predict the course of the disease and how to select the best treatment for each patient. In this condition, one third of patients have died within 3 months and half of patients have died at 1 year.
What is the purpose of the research?
The purpose of this study is to investigate how we can reduce mortality in patients with alcohol-related hepatitis. We will be collecting samples and data from patients. These samples and data will be used to investigate whether a blood test can diagnose alcohol-related hepatitis and so avoid the need for liver biopsy. The study will also investigate how healthcare professionals can predict disease outcome, patient infection and patient kidney damage. Finally, the study will also explore patients' experiences of AH to understand what is important to them and to identify potential barriers and facilitators to accessing treatment.
How are patients chosen to take part in the research?
Patients are chosen to take part as they have received a clinical diagnosis of alcohol-related hepatitis, or acute decompensation of cirrhosis (AD). Patients diagnosed with AD will be used as a comparison group for the AH patients being studied. Patients are being recruited through hepatology or hepatitis specialist clinics at different hospitals around the UK. Most patients will be able to decide for themselves as to whether or not they wish to participate in the research. For patients who are not able to consent themselves we will seek an opinion from a personal consultee (i.e. next of kin), or from a nominated consultee (i.e. the patients GP) who can give their opinion but are otherwise not connected to the research.
Do patients have to take part?
No. It is up to the patient to decide whether or not to take part. If they decide to take part they will be given a patient information sheet to keep and they will be asked to complete and sign a consent form. Patients are free to withdraw from the study at any time, and without giving a reason. Withdrawal from the study will not affect the standard of care the patient receives.
What are the possible benefits of the clinical studies (ISAIAH and MICAH) included in this project?
We cannot promise that the study will help patients personally. However, the knowledge we gain from the studies should help us improve the treatment offered to patients with alcohol-related liver disease in the future. Collecting patient samples for analysis in the laboratory is key to achieving this.
What will happen to the results of the research studies?
The results of clinical studies may take approximately 1 year to be reported. The results will be published in medical journals and presented at international scientific conferences. Patients that have participated in the studies will not be identified in any report or publication. The results are important as they may answer several questions for doctors looking after patients with severe alcohol-related hepatitis and could improve treatment for patients in the future.
Who is organising and funding the research?
Imperial Clinical Trials Unit is managing the day-to-day running of the studies. The Unit have a wealth of experience expertise running clinical studies. The Sponsor of the clinical studies is Imperial College London. The funding body financially supporting the consortium is the Medical Research Council. The study was designed by Professor Mark Thursz who is an expert in liver diseases.
Where to find more information about alcohol-related hepatitis
For any further questions about the disease or clinical trials, patients should discuss them with their healthcare professional. Patients may find it helpful to contact the British Liver Trust, who have a website and publications about the liver and liver disease. The British Liver Trust also have a helpline here.