Evidence map›Paper›PMID 19132805›Full record

Trial reportDrug safety2009

Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct.

Robert J Fontana, Paul B Watkins, Herbert L Bonkovsky, Naga Chalasani, Timothy Davern, Jose Serrano, James Rochon, DILIN Study Group

3 registry-linked trialsAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Drug safety, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 262 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
262citing papers in PubMed, 5 pooled it
24.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00345930 recruitingnot on this map

A Multi-Center, Longitudinal Study of Drug-and CAM-Induced Liver Injury

TypeobservationalSponsorDuke UniversityRan2004 to 2028Enrolled4,000ConditionsLiver Diseases
NCT04152837 phase3terminatednot on this mapstarted 2020, after this paper: background citation

An Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Previously Experienced Abnormal Liver Chemistry Test Results While Receiving Tolvaptan: The ALERT Study

TypeinterventionalSponsorPalladio BiosciencesRan2020 to 2022Enrolled7ConditionsPolycystic Kidney Disease, Adult, ADPKDArmsLixivaptan
NCT05208866 phase3terminatednot on this mapstarted 2022, after this paper: background citation

PA-ADPKD-304: A Phase 3, Open-label, Roll-over Study to Assess Long-term Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Who Completed Study PA-ADPKD-303: The ALERT Study

TypeinterventionalSponsorPalladio BiosciencesRan2022 to 2022Enrolled1ConditionsPolycystic Kidney Disease, AdultArmsLixivaptan
3 · Its place in the literature

Who cites it

262 citing papers in PubMed, 5 syntheses or guidelines pooled it, 477 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. [Diagnosis and treatment guideline on drug-induced liver injury].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2015
    Guideline
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Serum Hepatocyte Growth Factor Predicts Outcomes in Non-Acetaminophen Drug-Induced Acute Liver Failure.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Article
  10. Everolimus Related Acute Steatohepatitis Detected onNuclear medicine and molecular imaging · 2026
    Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Review
  17. The DILI-Inpt Prognostic Score to Identify Hospitalized Idiosyncratic DILI Patients at Risk for Adverse Outcomes.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
    Observational
  18. Liver Injury From Medications Used for Treating Inflammatory Bowel Disease: The Drug-Induced Liver Injury Network Experience.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Article
  19. Article
  20. Article

202 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 1 country.

Robert J FontanaDepartment of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan 48109-0362, USA. rfontana@med.umich.edu
Paul B Watkins
Herbert L Bonkovsky
Naga Chalasani
Timothy Davern
Jose Serrano
James Rochon
DILIN Study Group
Carolinas Medical Center · USClinical Research Institute · USIndiana University – Purdue University Indianapolis · USNational Institutes of Health · USUniversity of California, San Francisco · USUniversity of Michigan–Ann Arbor · USUniversity of North Carolina at Chapel Hill · US

Funding

Drug Induced Liver Injury Network Data Coordinating CenterU01DK065176 · NIDDK · DUKE UNIVERSITY · PI Huiman X Barnhart · 2003 to 2026
$25.5M
Coordinating Center for the Drug Induced Liver Injury Network (DILIN)U24DK065176 · NIDDK · DUKE UNIVERSITY · PI BARNHART, HUIMAN X · 2018 to 2022
$7.6M
IU Clinical Center: Drug Induced Liver Injury NetworkU01DK065211 · NIDDK · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI NAGA P CHALASANI · 2003 to 2026
$7.5M
University of North Carolina Clinical Center for DILINU01DK065201 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI PAUL B WATKINS · 2003 to 2026
$7.3M
Michigan Hepatotoxicity Clinical Research Network Renewal 2018U01DK065184 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ROBERT J FONTANA · 2003 to 2026
$7.0M
Hepatotoxicity Clinical Research NetworkU01DK065238 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DAVERN, TIMOTHY JAMES · 2003 to 2012
$1.9M
Research Network for Drug-Induced Liver DiseaseU01DK065193 · NIDDK · UNIVERSITY OF CONNECTICUT SCH OF MED/DNT · PI PROTIVA, PETR · 2003 to 2007
$1.2M
NIDDK NIH HHS 1U01DK065176NIDDK NIH HHS 1U01DK065184NIDDK NIH HHS 1U01DK065193NIDDK NIH HHS 1U01DK065201NIDDK NIH HHS 1U01DK065211NIDDK NIH HHS 1U01DK065238NIDDK NIH HHS U01 DK065176NIDDK NIH HHS U01 DK065184NIDDK NIH HHS U01 DK065193NIDDK NIH HHS U01 DK065201NIDDK NIH HHS U01 DK065211NIDDK NIH HHS U01 DK065238NIDDK NIH HHS U24 DK065176
6 · The paper itself

Abstract

backgroundDrug-induced liver injury (DILI) is an uncommon adverse drug reaction of increasing importance to the medical community, pharmaceutical industry, regulatory agencies and the general public.

objectivesThe Drug-Induced Liver Injury Network (DILIN) was established to advance understanding and research into DILI by initiating a prospective registry of patients with bona fide DILI for future studies of host clinical, genetic, environmental and immunological risk factors. The DILIN was also charged with developing standardized nomenclature, terminology and causality assessment instruments.

methodsFive clinical sites, a data coordinating centre and senior scientists from the National Institute of Diabetes and Digestive and Kidney Diseases initiated the DILIN prospective study in September 2004. Eligible patients are required to meet minimal laboratory or histological criteria within 6 months of DILI onset and have other competing causes of liver injury excluded. Patients in the general community setting with pre-existing HIV, hepatitis B virus or hepatitis C virus infections and/or abnormal baseline liver biochemistries are eligible for enrollment. In addition, subjects with liver injury due to herbal products are eligible to participate. Control patients without DILI are also to be recruited in the future.

resultsAll referred subjects undergo an extensive review of available laboratory, pathology and imaging studies. Subjects who meet pre-defined eligibility criteria at the 6-month study visit are followed for 2 years to better define the natural history of chronic DILI. Causality assessment is determined by a panel of three hepatologists who independently assign a causality score ranging from 1 (definite) to 5 (unlikely) as well as a severity score ranging from 1 (mild) to 5 (fatal). During the first 3 years, 367 subjects were enrolled into the DILIN prospective study.

conclusionDILIN is a multicentre research network charged with improving our understanding of the aetiologies, risk factors and outcomes of DILI in the US. The network is meeting the targeted enrollment of ten patients per month and is developing a repository of clinical data and biological samples for future studies of DILI pathogenesis and outcome.

Indexed as

Chemical and Drug Induced Liver InjuryDrug-Related Side Effects and Adverse ReactionsFollow-Up StudiesHumansNational Institute of Diabetes and Digestive and Kidney Diseases (U.S.)Prospective StudiesRegistriesResearch DesignRisk FactorsSeverity of Illness IndexTerminology as TopicUnited States

Identifiers

PMID19132805
PMCPMC3637941
OpenAlexW2060470911

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.