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

NIH RePORTER · NIH · U24 · $4,651,250 · view on reporter.nih.gov ↗

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
INDIANA UNIVERSITY INDIANAPOLIS
Principal Investigator
SAMER GAWRIEH
Activity code
U24
Funding institute
NIH
Fiscal year
2024
Award amount
$4,651,250
Award type
2
Project period
2018-08-01 → 2029-06-30