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

NCT ID: NCT01000766

Last Updated: 2017-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Drug Induced Liver Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute drug-induced liver injury

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* ALT \> 200 IU/L at presentation to UNC Hospitals
* Drug induced liver injury considered likely by admitting medical staff
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul B Watkins, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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50KR10957

Identifier Type: -

Identifier Source: org_study_id

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