Identifying Changes in Blood (Potential Biomarkers) in In... | NCT01000766

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

NCT01000766

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Apr 18, 2017Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Drug Induced Liver Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009Actual

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Oct 22, 2009

First Submission Date that Met QC Criteria

Oct 22, 2009

First Posted Date

Oct 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2017

Last Update Posted Date

Apr 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Actual

Label	Type	Description	Intervention Names
Acute drug-induced liver injury

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul B Watkins, MD	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina		Chapel Hill	North Carolina	27599	United States

Condition Browse Module

MeSH Terms

ID	Term
D056486	Chemical and Drug Induced Liver Injury

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D064420	Drug-Related Side Effects and Adverse Reactions
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided