# Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) - Indiana University Data Coordinating Center

> **NIH NIH U24** · INDIANA UNIVERSITY INDIANAPOLIS · 2024 · $4,651,250

## Abstract

Advanced alcohol-associated liver disease (ALD), which includes severe alcohol-associated hepatitis (sAH)
and decompensated alcohol-associated cirrhosis (DeAC), is primarily driven by alcohol use disorder and is a
significant contributor to liver-related morbidity and mortality. Presently, there are no FDA-approved therapies
for sAH or DeAC. This Data Coordinating Center (DCC) application is a part of a coordinated submission of the
Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) network. The network is a
continuation of the Alcoholic Hepatitis Network (AlcHepNet) funded by NIAAA. Collectively, the network will
synergize efforts and expertise to develop effective and safe therapies for advanced ALD. The ITAALD network
proposes to conduct two proof-of-concept randomized controlled trials: one targeting patients with sAH eligible
for steroid treatment and the other focusing on patients with DeAC ineligible for steroids. The DCC will serve
as a vital infrastructure facilitating the execution of these trials. Its application encompasses four overarching
objectives: (1) providing integrated administrative, clinical, and research support for the ITAALD trials; (2)
providing efficient and high-quality data management and analytical support; (3) establishing and maintaining
the network's biosample repository; and (4) expanding a research data commons established during the
previous funding cycle and enhancing its analytical capabilities. By ensuring the faithful implementation of the
ITAALD trials, the Indiana University DCC will safeguard the scientific integrity and reproducibility of the trials
outcomes. Furthermore, its biorepository and data commons will facilitate the analysis of biospecimens
generated by the network, fostering data dissemination within and beyond the ITAALD consortium.

## Key facts

- **NIH application ID:** 11078028
- **Project number:** 2U24AA026969-06
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** SAMER GAWRIEH
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $4,651,250
- **Award type:** 2
- **Project period:** 2018-08-01 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11078028

## Citation

> US National Institutes of Health, RePORTER application 11078028, Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) - Indiana University Data Coordinating Center (2U24AA026969-06). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/11078028. Licensed CC0.

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