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

Drug Induced Liver Injury Clinical Trial

Official title:

Identification of New Biomarkers of Drug Induced Liver Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000766
• Other study ID #: 50KR10957
• Status: Completed
• Phase: N/A
• First received: October 22, 2009
• Last updated: April 15, 2017
• Start date: September 2009
• Est. completion date: December 2013

Study information

• Verified date: April 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• ALT > 200 IU/L at presentation to UNC Hospitals

• Drug induced liver injury considered likely by admitting medical staff

Related Conditions & MeSH terms

• Drug Induced Liver Injury
• Drug-Induced Liver Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States,