Identifying Changes in Blood (Potential Biomarkers) in Individuals With Drug-Induced Liver Injury
This study is currently recruiting participants.
Verified March 2012 by University of North Carolina, Chapel Hill
Sponsor:
University of North Carolina, Chapel Hill
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
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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
Detailed Description:
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
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 Liver Diseases Digestive System Diseases Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 16, 2013