This application is submitted in response to RFA DK-07-012 which solicits applications from qualified investigators for the continuation and expansion of the Drug Induced Liver Injury Network (DILIN). Indiana University, one of the founder members and a top recruitment site, has robustly participated in all DILIN operations since its inception. In addition to accelerated subject recruitment, the DILIN during the next funding period will also focus on developing or supporting mechanistic and therapeutic ancillary studies, developing and validating optimal causality instruments and constructing in conjunction with NLM an authoritative hepatotoxicity database. 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 prospective and retrospective studies. We propose to collect prospective and retrospective cases of suspected DILI from multiple traditional as well as unique sources in Central Indiana, each providing distinctive epidemiological facets and research potential.
Specific Aim # 2: To robustly participate in the development and the support of mechanistic (genetic and non-genetic) and therapeutic ancillary studies by investigators within and outside the DILIN. We propose to conduct a network wide therapeutic ancillary pilot study of systemic steroids in patients with well characterized DILI during the next funding period.
Specific aim # 3: To continue to participate in a robust fashion in the causality assessment of suspected DILI cases that are enrolled into our ongoing studies and to play a major role in developing and validating new causality instrument(s) that are optimal and user-friendly.
Specific aim # 4: To develop, in conjunction with stake holders, an authoritative electronic DILI database, and outreach and educational activities for practicing physicians and the public. Our role will be extensive at conceptual, methodological, operational and contextual levels.
Specific aim # 5: The objective is to develop, in conjunction with other DILIN investigators, an international consortium of DILI to facilitate exchange of ideas, standardization of nomenclature, collaborative studies and cross validation of each other's observations and discoveries.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK065211-07S1
Application #
8029381
Study Section
Special Emphasis Panel (ZDK1-GRB-8 (O1))
Program Officer
Serrano, Jose
Project Start
2010-04-01
Project End
2011-01-31
Budget Start
2010-04-01
Budget End
2011-01-31
Support Year
7
Fiscal Year
2010
Total Cost
$102,400
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
Bonkovsky, Herbert L; Barnhart, Huiman X; Foureau, David M et al. (2018) Cytokine profiles in acute liver injury-Results from the US Drug-Induced Liver Injury Network (DILIN) and the Acute Liver Failure Study Group. PLoS One 13:e0206389
Dakhoul, Lara; Ghabril, Marwan; Gu, Jiezhun et al. (2018) Heavy Consumption of Alcohol is Not Associated With Worse Outcomes in Patients With Idiosyncratic Drug-induced Liver Injury Compared to Non-Drinkers. Clin Gastroenterol Hepatol 16:722-729.e2
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Whritenour, Jessica; Ko, Mira; Zong, Qing et al. (2017) Development of a modified lymphocyte transformation test for diagnosing drug-induced liver injury associated with an adaptive immune response. J Immunotoxicol 14:31-38
Björnsson, Einar S; Gu, Jiezhun; Kleiner, David E et al. (2017) Azathioprine and 6-Mercaptopurine-induced Liver Injury: Clinical Features and Outcomes. J Clin Gastroenterol 51:63-69
de Boer, Ynto S; Kosinski, Andrzej S; Urban, Thomas J et al. (2017) Features of Autoimmune Hepatitis in Patients With Drug-induced Liver Injury. Clin Gastroenterol Hepatol 15:103-112.e2

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