# Data Coordinating Center for the Alcoholic Hepatitis Research Network

> **NIH NIH U24** · INDIANA UNIVERSITY INDIANAPOLIS · 2021 · $1,452,545

## Abstract

ABSTRACT
Alcoholic hepatitis (AH) is a leading cause of liver-related morbidity and mortality with a remarkable paucity of
effective therapeutics. This application for a Data Coordinating Center (DCC) is part of a coordinated submission
of several NIAAA-funded consortia that have come together as the Alcoholic Hepatitis Network (AlcHepNet).
Collectively, the network will synergize efforts and expertise to better understand AH and develop novel effective
and safe therapies for severe AH. The overarching aims of this new consortium are to: 1) perform studies to
better understand the pathogenesis and main determinants of outcomes, particularly in severe AH; 2) identify
novel targets for therapy of AH, and 3) perform phase 2B studies of compounds that are already FDA approved
and available and can be repurposed as safe and effective therapies for severe AH. The DCC will be composed
of two complementary DCC Units – one at Indiana University School of Medicine (DCC IU), submitting this
application, and one at the University of Massachusetts Medical School (DCC UMMS), submitting the companion
application. Due to the complexity and breadth of studies and responsibilities of the combined DCC in the
AlcHepNet, the dual-DCC structure will provide the statistical and data management leadership to multiple
studies, including network-wide studies, multiple pilot randomized clinical trials (RCTs) and translational studies,
using innovations based on previous experience to facilitate the operations of these studies and supporting the
highest quality reproducible research. The aims of the dual DCC are: 1) Efficient and Effective Network
Management through development of a robust shared infrastructure including communication support and
administrative services to facilitate AlcHepNet objectives. 2) Provide high-level leadership to the scientific
methodology of the AlcHepNet, especially in the areas of study design, data management and statistical
analysis. 3) High Quality Study Implementation to ensure high quality, reproducible study results through a
rigorous program of quality assurance and control, study monitoring and DSMB and regulatory reporting. DCC
IU will be responsible for the two nine-center studies, a longitudinal observational study of AH patients and heavy
drinking controls and a three arm late phase clinical trial. By testing promising therapies for AH and collecting
well-annotated patient samples and datasets, the DCC for the AlcHeoNet will have a strong and lasting impact
on the field.

## Key facts

- **NIH application ID:** 10201431
- **Project number:** 5U24AA026969-04
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** SAMER GAWRIEH
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,452,545
- **Award type:** 5
- **Project period:** 2018-08-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10201431

## Citation

> US National Institutes of Health, RePORTER application 10201431, Data Coordinating Center for the Alcoholic Hepatitis Research Network (5U24AA026969-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10201431. Licensed CC0.

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