Combined liver-protecting and alcohol-use treatments for severe alcohol-associated hepatitis
Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) - Virginia Commonwealth University
This project sees if giving a new liver-supporting medicine together with FDA-approved alcohol medications and counseling helps people with severe alcohol-associated hepatitis survive and avoid returning to drinking.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Virginia Commonwealth University NIH-funded |
| Lab location | 1 site (Richmond, United States) |
| Project ID | NIH-11195166 on NIH RePORTER |
What this research studies
If you join, you would be randomly started on either a novel IL-22 fusion medicine or the standard prednisone for the first 28 days, with an early check at day 7 to stop treatment if needed. People who make it past the first week will be re-randomized to receive acamprosate plus counseling (motivational interviewing and motivational enhancement therapy) or the usual care for alcohol use. The team combines liver disease and addiction experts and aims to reduce stigma and improve follow-up care. Researchers will look at deaths, liver health, and drinking outcomes at six months to see if the combined approach helps.
Who could benefit from this research
Good fit: Adults diagnosed with severe alcohol-associated hepatitis who can receive the study medications and participate in follow-up and counseling would be the ideal candidates.
Not a fit: People with milder forms of alcohol-related liver disease, those who cannot take the study drugs, or those unwilling/unable to engage in counseling may not benefit from this project.
Why it matters
Potential benefit: If successful, this approach could lower short-term deaths, limit liver damage, and help people stop drinking after severe alcohol-associated hepatitis.
How similar studies have performed: Prednisone is a known treatment for severe alcohol-associated hepatitis and acamprosate is effective for alcohol use disorder, but combining an IL-22 fusion protein with alcohol-medication plus counseling for this condition is largely new and untested.
Where this research is happening
Richmond, United States
- Virginia Commonwealth University — Richmond, United States (Active)
Researchers
- Principal investigator: Arab, Juan Pablo — Virginia Commonwealth University
- Study coordinator: Arab, Juan Pablo
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.