Liver DiseasesNCT00345930
DILIN - Prospective Study
An observational study of Liver Diseases, run by Duke University at 6 sites in United States.
Trial summary
The purpose of this study is to identify individuals who have suffered a liver injury arising as an idiosyncratic reaction to a prescription drug or a complementary and alternative medicine. Recently added acute cases enrollment that meets criteria to the protocol. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- How many people
- 4,000 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2004to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who have suffered a drug induced liver injury and meet inclusion and exclusion criteria
Who may be able to join
- Age > 2 years at enrollment into the study.
- Evidence of liver injury that is known or suspected to be related to consumption of a drug or CAM product in the 6-month period prior to enrollment.
- Written Informed consent from the patient or the patient's legal guardian.
- Documented clinically important DILI, defined as any of the following:
- ALT or AST >5 x ULN or A P'ase >2 x ULN confirmed on at least 2 consecutive blood draws in patients with previously normal values.
- If baseline (BL) ALT, AST or A P'ase are known to be elevated, then ALT or AST >5 x BL or A P'ase >2 x BL on at least 2 consecutive blood draws. "Baseline" is defined as the average of at least 2 measurements performed during the 12-month period prior to starting the DILI medication.
- Any elevation of ALT, A P'ase, or AST, associated with (a) increased total bilirubin [ ≥ 2.5 mg/dL], in absence of prior diagnosis of liver disease, Gilbert's syndrome, or evidence of hemolysis or (b) coagulopathy with INR > 1.5 in absence of coumadin therapy or known vitamin K deficiency.
Who cannot join
- Patients with any of the following will not be eligible for participation:
- Competing cause of acute liver injury such as hepatic ischemia that is felt by the investigator to be the primary reason for observed liver injury and supported by laboratory tests, serologies, liver biopsy, or radiology.
- Known, pre-existing autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease which may confound the ability to make a diagnosis of DILI.
- Acetaminophen hepatotoxicity.
- Liver/bone marrow transplant prior to the development of drug- or CAM-induced liver injury.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109-0362
Josefa Kaganove, kaganovj@med.umich.edu
Robert J Fontana, MD
- Recruiting
NIH Clinical Site
Bethesda, Maryland, 20892
Jaha nor, 301-435-6122, jaha.norman-wheeler@nih.gov
Christopher Koh, MD
- Recruiting
Univeristy of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7600
Jacquee Simpson, Jacqueline_Simpson@med.unc.edu
None Available
- Recruiting
Indiana University
Indianapolis, Indiana, 46202-5111
Jennifer Terrell, 317-278-6266, jkramey@iu.edu
Naga P Chalasani, MD
- Recruiting
University of Southern California
Los Angeles, California, 90033
Susan Milstein, RN, BSN, 323-224-5441, smilstei@usc.edu
Andrew Stolz, MD
- Recruiting
Thomas Jefferson
Philadelphia, Pennsylvania, 19141
Katrin Koy, 215-456-2004, koykatri@einstein.edu
Dina Halegoua-DeMarzio, MD
About this study
Official title: A Multi-Center, Longitudinal Study of Drug-and CAM-Induced Liver Injury
The purpose of this study is to identify individuals who have suffered a liver injury arising as an idiosyncratic reaction to a prescription drug or a complementary and alternative medicine. Recently added acute cases enrollment that meets criteria to the protocol. Also added Fibroscans to the protocol that will be completed at baseline and follow-up on chronic subjects.
Read the detailed description
Liver injury due to prescription and non-prescription medication use is a medical, scientific and public health problem of increasing frequency and importance in the United States. Indeed, drug-induced liver injury (DILI) is the most important reason for non-approval, withdrawal, limitation in use and clinical monitoring by the Food and Drug Administration (FDA). However, detection of signals for liver injury frequently relies upon the reporting of cases by practitioners to health authorities in post-marketing surveillance. Under-reporting of cases, lack of mandatory reporting systems, and difficulties in establishing a diagnosis make the current system sub-optimal. Moreover, with the growing use of complementary and alternative medications (CAM), there have also been increasing reports of liver toxicity due to various non-prescription herbal, dietary and food additive supplements. Because the manufacturing, dispensing and testing of these products is not regulated, the hepatotoxic potential of these formulations is poorly characterized or completely unknown.
The DILIN Prospective Study is a multi-centered epidemiological study designed to gather clinical information and biological specimens on cases of suspected liver injury due to drugs and CAM. The goals of this study are to develop a database of recent DILI cases, identify the clinical, environmental and genetic risk factors that predict DILI, develop standardized instruments and terminology and perform careful longitudinal follow-up of DILI subjects. Biological samples collected will be used in future studies of the mechanisms and genetics of DILI.
Patients who are referred to one of the DILIN clinical sites and who, in the opinion of gastroenterologist/hepatologist, experienced a drug-induced liver injury are enrolled. Detailed clinical data and biological specimens are collected. Clinical data will be reviewed by the DILIN Causality Committee and the final determination on whether the subject qualifies as a bona fide DILI case is made by consensus opinion. DILI cases (only) are followed for at least 6 months to derive the longitudinal profile of drug-and CAM-induced liver injury. Detailed clinical data including liver elastography (FibroScans) and biological specimens are collected. Patients who satisfy the definition of chronic DILI will be evaluated with additional FibroScans at 12, 24, 36 and 48 months thereafter.
- Conditions
- Liver Diseases
- Keywords
- Complementary and alternative medicine, Complementary therapies, Alternative therapies, Prescription Drugs, Non prescription Drugs, Liver Disease, Chemical Ind, Phenotype, Proteomics, Metabolomics, Cholestatic Liver Injury, Hepatocellular Liver Injury, Mixed Liver Injury, Matched Case Control Studies, Genotype, Liver Dis, Chem Ind
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Individuals without drug induced liver disease | |
| 1 | Individuals with drug induced liver disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a database of recent DILI cases
develop a database of recent DILI cases
Measured: July 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startSep 2004
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huiman X. Barnhart, PhD, Principal investigator, Duke UniversityRobert Fontana, MD, Study chair, Univ. of Michiganl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345930
- Sponsor's protocol ID
- Pro00113362_1
- Other IDs
- U01DK065176, Pro00072297, Pro00017208
- Status last verified
- Apr 2026
- First submitted
- 27 Jun 2006
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fontana RJ, Watkins PB, Bonkovsky HL, Chalasani N, Davern T, Serrano J, Rochon J; DILIN Study Group. Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct. Drug Saf. 2009;32(1):55-68. doi: 10.2165/00002018-200932010-00005.
PubMed 19132805Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang H, Rochon J; Drug Induced Liver Injury Network (DILIN). Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology. 2008 Dec;135(6):1924-34, 1934.e1-4. doi: 10.1053/j.gastro.2008.09.011. Epub 2008 Sep 17.
PubMed 18955056Zaborenko CJ, Schwantes-An TH, Li YJ, Dellinger A, Nicoletti P, Daly AK, Aithal G, Chalasani N; Drug-Induced Liver Injury Network. HLA and non-HLA genetic analyses reveal suggestive variants associated with statin-induced liver injury. Hepatol Commun. 2026 Aug 28;10(9):e1026. doi: 10.1097/HC9.0000000000001026. eCollection 2026 Sep 1.
PubMed 42684112Gopalakrishna H, Ghabril M, Gu J, Li YJ, Fontana RJ, Kleiner DE, Koh C, Chalasani N; Drug-Induced Liver Injury Network. Drug-induced Liver Injury Due to Medications for Alcohol Use Disorder: Results From the DILIN Prospective Study. J Addict Med. 2025 May-Jun 01;19(3):314-321. doi: 10.1097/ADM.0000000000001421. Epub 2024 Dec 9.
PubMed 39651750Bonkovsky HL, Ghabril M, Nicoletti P, Dellinger A, Fontana RJ, Barnhart H, Gu J, Daly AK, Aithal GP, Phillips EJ, Kleiner DE; US DILIN Investigators. Drug-induced liver injury (DILI) ascribed to non-steroidal anti-inflammatory drugs (NSAIDs) in the USA-Update with genetic correlations. Liver Int. 2024 Jun;44(6):1409-1421. doi: 10.1111/liv.15892. Epub 2024 Mar 7.
PubMed 38451034Fontana RJ, Li YJ, Vuppalanchi R, Kleiner DE, Gu J, Shroff H, Van Wagner LB, Watkins PB; US DILIN study group. ERAP-1 and ERAP-2 Variants in Liver Injury After COVID-19 mRNA Vaccination: A US Multicenter Study. Am J Gastroenterol. 2024 Aug 1;119(8):1496-1505. doi: 10.14309/ajg.0000000000002702. Epub 2024 Feb 5.
PubMed 38314748Fontana RJ, Kleiner DE, Chalasani N, Bonkovsky H, Gu J, Barnhart H, Li YJ, Hoofnagle JH. The Impact of Patient Age and Corticosteroids in Patients With Sulfonamide Hepatotoxicity. Am J Gastroenterol. 2023 Sep 1;118(9):1566-1575. doi: 10.14309/ajg.0000000000002232. Epub 2023 Feb 27.
PubMed 36848311Fontana RJ, Engle RE, Hayashi PH, Gu J, Kleiner DE, Nguyen H, Barnhart H, Hoofnagle JH, Farci P. Incidence of Hepatitis E Infection in American Patients With Suspected Drug-Induced Liver Injury Is Low and Declining: The DILIN Prospective Study. Am J Gastroenterol. 2022 Sep 1;117(9):1462-1470. doi: 10.14309/ajg.0000000000001869. Epub 2022 Jun 10.
PubMed 35973149Devarbhavi H, Ghabril M, Barnhart H, Patil M, Raj S, Gu J, Chalasani N, Bonkovsky HL. Leflunomide-induced liver injury: Differences in characteristics and outcomes in Indian and US registries. Liver Int. 2022 Jun;42(6):1323-1329. doi: 10.1111/liv.15189. Epub 2022 Feb 15.
PubMed 35129282Vuppalanchi R, Bonkovsky HL, Ahmad J, Barnhart H, Durazo F, Fontana RJ, Gu J, Khan I, Kleiner DE, Koh C, Rockey DC, Phillips EJ, Li YJ, Serrano J, Stolz A, Tillmann HL, Seeff LB, Hoofnagle JH, Navarro VJ; Drug-Induced Liver Injury Network. Garcinia cambogia, Either Alone or in Combination With Green Tea, Causes Moderate to Severe Liver Injury. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1416-e1425. doi: 10.1016/j.cgh.2021.08.015. Epub 2021 Aug 14.
PubMed 34400337Martinez MA, Vuppalanchi R, Fontana RJ, Stolz A, Kleiner DE, Hayashi PH, Gu J, Hoofnagle JH, Chalasani N. Clinical and histologic features of azithromycin-induced liver injury. Clin Gastroenterol Hepatol. 2015 Feb;13(2):369-376.e3. doi: 10.1016/j.cgh.2014.07.054. Epub 2014 Aug 9.
PubMed 25111234Navarro VJ, Barnhart H, Bonkovsky HL, Davern T, Fontana RJ, Grant L, Reddy KR, Seeff LB, Serrano J, Sherker AH, Stolz A, Talwalkar J, Vega M, Vuppalanchi R. Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Hepatology. 2014 Oct;60(4):1399-408. doi: 10.1002/hep.27317. Epub 2014 Aug 25.
PubMed 25043597Ghabril M, Bonkovsky HL, Kum C, Davern T, Hayashi PH, Kleiner DE, Serrano J, Rochon J, Fontana RJ, Bonacini M; US Drug-Induced Liver Injury Network. Liver injury from tumor necrosis factor-alpha antagonists: analysis of thirty-four cases. Clin Gastroenterol Hepatol. 2013 May;11(5):558-564.e3. doi: 10.1016/j.cgh.2012.12.025. Epub 2013 Jan 17.
PubMed 23333219
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Longitudinal Study of Drug-and CAM-Induced Liver Injury
- ClinicalTrials.gov ID
- NCT00345930
- Acronym / sponsor ID
- Pro00113362_1
- Conditions
- Liver Diseases
- Keywords
- Complementary and alternative medicine, Complementary therapies, Alternative therapies, Prescription Drugs, Non prescription Drugs, Liver Disease, Chemical Ind, Phenotype
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2004 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify individuals who have suffered a liver injury arising as an idiosyncratic reaction to a prescription drug or a complementary and alternative medicine. Recently added acute cases enrollment that meets criteria to the protocol. Also added Fibroscans to the protocol that will be completed at baseline and follow-up on chronic subjects.
Detailed description
Liver injury due to prescription and non-prescription medication use is a medical, scientific and public health problem of increasing frequency and importance in the United States. Indeed, drug-induced liver injury (DILI) is the most important reason for non-approval, withdrawal, limitation in use and clinical monitoring by the Food and Drug Administration (FDA). However, detection of signals for liver injury frequently relies upon the reporting of cases by practitioners to health authorities in post-marketing surveillance. Under-reporting of cases, lack of mandatory reporting systems, and difficulties in establishing a diagnosis make the current system sub-optimal. Moreover, with the growing use of complementary and alternative medications (CAM), there have also been increasing reports of liver toxicity due to various non-prescription herbal, dietary and food additive supplements. Because the manufacturing, dispensing and testing of these products is not regulated, the hepatotoxic potential of these formulations is poorly characterized or completely unknown.
The DILIN Prospective Study is a multi-centered epidemiological study designed to gather clinical information and biological specimens on cases of suspected liver injury due to drugs and CAM. The goals of this study are to develop a database of recent DILI cases, identify the clinical, environmental and genetic risk factors that predict DILI, develop standardized instruments and terminology and perform careful longitudinal follow-up of DILI subjects. Biological samples collected will be used in future studies of the mechanisms and genetics of DILI.
Patients who are referred to one of the DILIN clinical sites and who, in the opinion of gastroenterologist/hepatologist, experienced a drug-induced liver injury are enrolled. Detailed clinical data and biological specimens are collected. Clinical data will be reviewed by the DILIN Causality Committee and the final determination on whether the subject qualifies as a bona fide DILI case is made by consensus opinion. DILI cases (only) are followed for at least 6 months to derive the longitudinal profile of drug-and CAM-induced liver injury. Detailed clinical data including liver elastography (FibroScans) and biological specimens are collected. Patients who satisfy the definition of chronic DILI will be evaluated with additional FibroScans at 12, 24, 36 and 48 months thereafter.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | – | –Individuals without drug induced liver disease |
| 1 | – | –Individuals with drug induced liver disease |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have suffered a drug induced liver injury and meet inclusion and exclusion criteria
Key inclusion criteria (7 listed)
- Age > 2 years at enrollment into the study.
- Evidence of liver injury that is known or suspected to be related to consumption of a drug or CAM product in the 6-month period prior to enrollment.
- Written Informed consent from the patient or the patient's legal guardian.
- Documented clinically important DILI, defined as any of the following:
Key exclusion criteria (5 listed)
- Competing cause of acute liver injury such as hepatic ischemia that is felt by the investigator to be the primary reason for observed liver injury and supported by laboratory tests, serologies, liver biopsy, or radiology.
- Known, pre-existing autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease which may confound the ability to make a diagnosis of DILI.
- Acetaminophen hepatotoxicity.
- Liver/bone marrow transplant prior to the development of drug- or CAM-induced liver injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop a database of recent DILI cases
Time frame: July 2028
develop a database of recent DILI cases
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 19132805Fontana RJ, Watkins PB, Bonkovsky HL, Chalasani N, Davern T, Serrano J, Rochon J; DILIN Study Group. Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct. Drug Saf. 2009;32(1):55-68. doi: 10.2165/00002018-200932010-00005.
- Background: PubMed 18955056Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang H, Rochon J; Drug Induced Liver Injury Network (DILIN). Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology. 2008 Dec;135(6):1924-34, 1934.e1-4. doi: 10.1053/j.gastro.2008.09.011. Epub 2008 Sep 17.
- Derived from this study: PubMed 42684112Zaborenko CJ, Schwantes-An TH, Li YJ, Dellinger A, Nicoletti P, Daly AK, Aithal G, Chalasani N; Drug-Induced Liver Injury Network. HLA and non-HLA genetic analyses reveal suggestive variants associated with statin-induced liver injury. Hepatol Commun. 2026 Aug 28;10(9):e1026. doi: 10.1097/HC9.0000000000001026. eCollection 2026 Sep 1.
- Derived from this study: PubMed 39651750Gopalakrishna H, Ghabril M, Gu J, Li YJ, Fontana RJ, Kleiner DE, Koh C, Chalasani N; Drug-Induced Liver Injury Network. Drug-induced Liver Injury Due to Medications for Alcohol Use Disorder: Results From the DILIN Prospective Study. J Addict Med. 2025 May-Jun 01;19(3):314-321. doi: 10.1097/ADM.0000000000001421. Epub 2024 Dec 9.
- Derived from this study: PubMed 38451034Bonkovsky HL, Ghabril M, Nicoletti P, Dellinger A, Fontana RJ, Barnhart H, Gu J, Daly AK, Aithal GP, Phillips EJ, Kleiner DE; US DILIN Investigators. Drug-induced liver injury (DILI) ascribed to non-steroidal anti-inflammatory drugs (NSAIDs) in the USA-Update with genetic correlations. Liver Int. 2024 Jun;44(6):1409-1421. doi: 10.1111/liv.15892. Epub 2024 Mar 7.
- Derived from this study: PubMed 38314748Fontana RJ, Li YJ, Vuppalanchi R, Kleiner DE, Gu J, Shroff H, Van Wagner LB, Watkins PB; US DILIN study group. ERAP-1 and ERAP-2 Variants in Liver Injury After COVID-19 mRNA Vaccination: A US Multicenter Study. Am J Gastroenterol. 2024 Aug 1;119(8):1496-1505. doi: 10.14309/ajg.0000000000002702. Epub 2024 Feb 5.
- Derived from this study: PubMed 36848311Fontana RJ, Kleiner DE, Chalasani N, Bonkovsky H, Gu J, Barnhart H, Li YJ, Hoofnagle JH. The Impact of Patient Age and Corticosteroids in Patients With Sulfonamide Hepatotoxicity. Am J Gastroenterol. 2023 Sep 1;118(9):1566-1575. doi: 10.14309/ajg.0000000000002232. Epub 2023 Feb 27.
- Derived from this study: PubMed 35973149Fontana RJ, Engle RE, Hayashi PH, Gu J, Kleiner DE, Nguyen H, Barnhart H, Hoofnagle JH, Farci P. Incidence of Hepatitis E Infection in American Patients With Suspected Drug-Induced Liver Injury Is Low and Declining: The DILIN Prospective Study. Am J Gastroenterol. 2022 Sep 1;117(9):1462-1470. doi: 10.14309/ajg.0000000000001869. Epub 2022 Jun 10.
- Derived from this study: PubMed 35129282Devarbhavi H, Ghabril M, Barnhart H, Patil M, Raj S, Gu J, Chalasani N, Bonkovsky HL. Leflunomide-induced liver injury: Differences in characteristics and outcomes in Indian and US registries. Liver Int. 2022 Jun;42(6):1323-1329. doi: 10.1111/liv.15189. Epub 2022 Feb 15.
- Derived from this study: PubMed 34400337Vuppalanchi R, Bonkovsky HL, Ahmad J, Barnhart H, Durazo F, Fontana RJ, Gu J, Khan I, Kleiner DE, Koh C, Rockey DC, Phillips EJ, Li YJ, Serrano J, Stolz A, Tillmann HL, Seeff LB, Hoofnagle JH, Navarro VJ; Drug-Induced Liver Injury Network. Garcinia cambogia, Either Alone or in Combination With Green Tea, Causes Moderate to Severe Liver Injury. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1416-e1425. doi: 10.1016/j.cgh.2021.08.015. Epub 2021 Aug 14.
- Derived from this study: PubMed 25111234Martinez MA, Vuppalanchi R, Fontana RJ, Stolz A, Kleiner DE, Hayashi PH, Gu J, Hoofnagle JH, Chalasani N. Clinical and histologic features of azithromycin-induced liver injury. Clin Gastroenterol Hepatol. 2015 Feb;13(2):369-376.e3. doi: 10.1016/j.cgh.2014.07.054. Epub 2014 Aug 9.
- Derived from this study: PubMed 25043597Navarro VJ, Barnhart H, Bonkovsky HL, Davern T, Fontana RJ, Grant L, Reddy KR, Seeff LB, Serrano J, Sherker AH, Stolz A, Talwalkar J, Vega M, Vuppalanchi R. Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Hepatology. 2014 Oct;60(4):1399-408. doi: 10.1002/hep.27317. Epub 2014 Aug 25.
- Multi-center, Longitudinal Study of Drug- and CAM-Induced Liver Injury.Link provided by the sponsor.
- The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports biomedical research and disseminates research findings \& health information to the public.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huiman X. Barnhart, PhD principal investigator
Duke University
Robert Fontana, MD study chair
Univ. of Michiganl
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by Duke University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eilene Pham (9196607253, eilene.pham@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a database of recent DILI cases (time frame: July 2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00345930, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.