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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of North Carolina, Chapel Hill.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Paul Watkins, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01000766
First received: October 22, 2009
Last updated: March 3, 2012
Last verified: March 2012
  Purpose

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.


Condition
Drug Induced Liver Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of New Biomarkers of Drug Induced Liver Injury

Further study details as provided by University of North Carolina, Chapel Hill:

Biospecimen Retention:   Samples Without DNA

blood


Estimated Enrollment: 25
Study Start Date: September 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute drug-induced liver injury

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • ALT > 200 IU/L at presentation to UNC Hospitals
  • Drug induced liver injury considered likely by admitting medical staff
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000766

Contacts
Contact: Paul B Watkins, MD 919-226-3140 paul_watkins@med.unc.edu

Locations
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Paul B Watkins, MD    919-226-3143    paul_watkins@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Paul B Watkins, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Paul Watkins, Professor of Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01000766     History of Changes
Other Study ID Numbers: 50KR10957
Study First Received: October 22, 2009
Last Updated: March 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Drug-Induced Liver Injury
Wounds and Injuries
Liver Diseases
Digestive System Diseases
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 29, 2014