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CompletedNCT01000766Updated Apr 18, 2017

Identifying Changes in Blood (Potential Biomarkers) in Individuals With Drug-Induced Liver Injury

An observational study in Drug Induced Liver Injury, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-04-18.

Sponsored by University of North Carolina, Chapel Hill · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 80 Years
Sex
All
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Study summary

The purpose of this study is to try to develop new blood tests that may help doctors identify if a drug is hurting a person's liver.

Read the detailed description

Our hypothesis is that there are liver-specific particles, called mRNA, that are identifiable in a person's blood sample during liver injury caused by some drugs. The purpose of this study is to try to develop new blood tests that may help doctors identify if a drug is hurting a person's liver, perhaps early in the process before significant injury or illness have occurred.

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Conditions studied

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In context

Chemical and Drug Induced Liver Injury

75 studies on the registry are indexed under Chemical and Drug Induced Liver Injury; 20 are open to participants now.

This study's enrollment of 25 is below the median of 504 across 38 observational studies indexed under Chemical and Drug Induced Liver Injury.

Browse Chemical and Drug Induced Liver Injury studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients will be identified in emergency rooms or inpatients at the University of North Carolina Memorial Hospital.

Eligibility criteria

Inclusion Criteria:

  • ALT > 200 IU/L at presentation to UNC Hospitals
  • Drug induced liver injury considered likely by admitting medical staff
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Acute drug-induced liver injury
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Study locations

1 site
  • University of North Carolina
    Chapel Hill, North Carolina 27599, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01000766
Lead sponsor
University of North Carolina, Chapel Hill
Responsible party
Sponsor
First posted
Oct 23, 2009
Start date
Sep 2009
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Apr 18, 2017

Study contacts

Paul B Watkins, MD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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