Acetaminophen Biomarkers | NCT01005173

Studies
Acetaminophen Biomarkers

NCT01005173

Sponsor

Arkansas Children's Hospital Research Institute

Status

Unknown status

Last Update Posted

Nov 24, 2017Actual

Enrollment

253Estimated

Phase

Not provided

Conditions

Acetaminophen Toxicity

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

ID	Type	Description	Link
1 R01 DK081406-01A1 - NIH

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jun 2018Estimated

Completion Date

Not provided

First Submitted Date

Oct 28, 2009

First Submission Date that Met QC Criteria

Oct 29, 2009

First Posted Date

Oct 30, 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

Nov 21, 2017

Last Update Posted Date

Nov 24, 2017Actual

Name	Class
National Institutes of Health (NIH)	NIH

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

This study is a non-intervention, multicenter study to address biomarkers of acetaminophen toxicity in children. Specifically, the study will examine acetaminophen (APAP) protein adducts and markers of liver injury in the blood samples of hospitalized children and adolescents who are receiving standard doses of acetaminophen, and children and adolescents who are status post acetaminophen overdose. Ultimately, the data generated from this study will be used to establish second generation biomarkers of acetaminophen toxicity, based on specific adduct proteins, which can be used in future risk assessment studies of children receiving acetaminophen.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

253Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Subjects receiving recommended doses of acetaminophen in the hospital. 140 Subjects
Group B		Healthy Volunteers - No acetaminophen exposure within 14 days of enrollment 23 Subjects
Group C		Acetaminophen Overdose Subjects - Hospitalized 90 Subjects

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Group A:

Children ages 1-18 inclusive
Hospitalized children who are likely to receive or are receiving recommended doses of APAP

Group B:

Children ages 1-18 inclusive
Children with no APAP use in the past 14 days

Group C:

Children ages 1-18 inclusive
Hospitalized from an acute overdose of APAP
Time of APAP overdose is known or can be estimated within a two hour window

Exclusion Criteria:

Group A:

Acute or chronic APAP overdose within 14 days
Known history of liver disease or dysfunction

Group B:

APAP within the last 14 days
Known history of liver disease or dysfunction

Group C:

Chronic overdoses of APAP, defined as multiple time point ingestions of APAP
History of previous APAP overdose
Known pre-existing liver disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children Ages 1-18

Group A - Hospitalized receiving acetaminophen

Group B - Healthy volunteers - no acetaminophen within 14 days

Group C - Acetaminophen Overdose - Hospitalized

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura P James, MD	Arkansas Children's Hospital Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Hospital		Little Rock	Arkansas	72202	United States
Children's National Medical Center