Summary
This project aims to develop and assess integrated therapies for severe alcohol-associated hepatitis (sAH) by combining treatments for alcohol-associated liver disease (ALD) and alcohol use disorder (AUD) to improve patient outcomes.
Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) - Virginia Commonwealth University
US · VA
National Institutes of Health
grant
open
#nih-5U01AA026979-07
What they want
The project proposes a sequential, multiple assignment, randomized trial to evaluate the safety and efficacy of integrated therapies in sAH. Aim 1 involves a trial comparing a novel IL-22 fusion protein to prednisone, with survivors re-randomized to acamprosate plus motivational interview (MI) and motivational enhancement therapy (MET) or usual care for AUD. The primary endpoint is a composite measure of mortality, liver, and alcohol use outcomes at 6 months. Aim 2 focuses on building a platform for biosamples, data repositories, and patient registries to support ancillary studies leveraging existing AlcHepNet resources.
Deliverables
- Clinical trial results on safety and efficacy of integrated therapies for sAH
- Platform for biosamples
- Data repositories
- Patient registries
Technical requirements
- Sequential, multiple assignment, randomized trial design
- Use of IL-22 fusion protein
- Use of prednisone
- Day-7 Lille stopping rule
- Use of acamprosate
- Motivational Interview (MI) sessions
- Motivational Enhancement Therapy (MET) sessions
