Integrated Approaches for Identifying Molecular Targets in Liver Disease (NCT03915002) | Clinical Trial Compass
CompletedNot Applicable
Integrated Approaches for Identifying Molecular Targets in Liver Disease
United States155 participantsStarted 2019-06-13
Plain-language summary
To provide a framework for successful clinical trials testing novel targets for therapy in liver disease.
To identify molecular and cellular drivers of liver disease to provide a molecular classification and study the determinants or key drivers of disease progression.
Consecutive patients admitted with steatohepatitis (alcoholic or non-alcoholic) will be enrolled in this study where liver tissue, blood and stool will be collected to discover and validate factors associated with diagnosis, severity, histological characteristics, development of decompensations, progression of disease and survival.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patients with Alcoholic hepatitis:
* Inclusion:
• Patients with a previous probable or possible AH episode will be defined following the guidelines proposed by the NIAAA.
* Exclusion
* Terminal illness with less than 6 months live expectancy (e.g. advanced hepatocellular
* carcinoma).
* Patients who are pregnant or breastfeeding.
* Complete portal vein thrombosis (PVT).
* Previous liver transplant recipient
Patients with cirrhosis due to alcohol related liver disease without AH with or without a prior episode of decompensation.
* Inclusion:
• Patients with a diagnosis of cirrhosis due to alcohol related liver disease according to clinical and/or analytic and/or radiological criteria.
* Exclusion
* Terminal illness with less than 6 months live expectancy (e.g. advanced hepatocellular carcinoma).
* Patients who are pregnant or breastfeeding.
* Complete portal vein thrombosis
* Previous liver transplant recipient
* Current alcoholic hepatitis episode
Alcoholic liver disease with compensated never decompensated liver disease.
* Inclusion:
* Patients diagnosed with an alcohol use disorder identification test (AUDIT) total scores of 8 or more OR Patients with a score lower than 8 in the AUDIT test but for whom there is a high suspicion of current or recent (within one year) AUD based on medical history, self reported history of excessive alcohol use, stigmata of alcohol use on physical exam, liver chemistry abnormalities, or alcohol induced organ…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Molecular Subtypes for Targeted Therapies in Liver disease
Timeframe: 5 years
2
Determination of key drivers of the disease progression
Timeframe: 5-10 years
3
repository capable of providing a framework fro the other outcomes