NCT01000766

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

4.3 years

First QC Date

October 22, 2009

Last Update Submit

April 15, 2017

Conditions

Drug Induced Liver Injury

Study Arms (1)

Acute drug-induced liver injury

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Study Officials

  • Paul B Watkins, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 23, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

US(1)