# IU Clinical Center: Drug Induced Liver Injury Network

> **NIH NIH U01** · INDIANA UNIVERSITY INDIANAPOLIS · 2022 · $348,402

## Abstract

PROJECT SUMMARY/ABSTRACT
This application is being submitted in response to RFA DK-17-509 which solicits applications from qualified
investigators for the continuation of the Drug Induced Liver Injury Network (DILIN). Indiana University is one of
the five founding clinical centers and has robustly participated in all DILIN operations since its inception. We
propose the following specific aims to meet the goals of this RFA. Specific Aim # 1: To enroll large number of
eligible adults and children with suspected DILI into ongoing DILIN studies. We propose to collect acute,
prospective and retrospective cases of suspected DILI from multiple sources in Central Indiana, each providing
distinctive epidemiological facets and research potential. A special focus of this aim is to robustly enroll two
subpopulations: (a) individuals with suspected liver injury due to chemo-and immunotherapeutic agents; and
(b) individuals with severe skin adverse reactions who also exhibit liver injury. Specific Aim # 2: To conduct
three distinct ancillary studies, each one adding significantly to our understanding of DILI. These include: (a) to
develop and validate a model consisting of severity of liver injury and co-morbidities to predict six-month
mortality in individuals presenting with DILI; (b) to systematically search for medications as triggers for new-
onset autoimmune hepatitis; and (c) to investigate HLA variants associated with DILI with immunoallergic
features including skin reactions. Specific Aim # 3: DILI carries considerable mortality and morbidity but
there is no treatment available other than withdrawing the offending agent. In order to address this unmet
therapeutic need, we propose to conduct a randomized, double-blind, placebo-controlled pilot study of
budesonide in individuals with well characterized hepatocellular DILI meeting predefined eligibility criteria. Our
hypothesis is that oral budesonide, a steroid with high glucocorticoid activity and substantial first pass
elimination, attenuates liver injury and improves outcomes of patients with hepatocellular DILI. Fifty individuals
with definite, highly likely or probably DILI with hepatocellular DILI (R>5) and total bilirubin > 5 mg/dL will be
randomized to receive either budesonide (9 mg once daily) or placebo for 4 weeks. Primary efficacy endpoint
is proportion of patients with improvement in total bilirubin from peak to 2.5 mg/dL at 4 weeks. Primary safety
endpoint is the proportion of patients with serious adverse events in each group. Specific Aim # 4: The
objective is to robustly participate in the cross-consortia activities including participating and leading (where
appropriate) steering committee, genetics committee, ancillary studies committee, publications and
presentations committee, causality committee, and herbal and dietary supplements (HDS) committee activities.

## Key facts

- **NIH application ID:** 10470772
- **Project number:** 5U01DK065211-20
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** NAGA P CHALASANI
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $348,402
- **Award type:** 5
- **Project period:** 2003-09-30 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10470772

## Citation

> US National Institutes of Health, RePORTER application 10470772, IU Clinical Center: Drug Induced Liver Injury Network (5U01DK065211-20). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10470772. Licensed CC0.

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