Status unknownNCT01005173Updated Nov 24, 2017

Acetaminophen Biomarkers

An observational study in Acetaminophen Toxicity, sponsored by Arkansas Children's Hospital Research Institute. Status unknown at 8 sites in United States. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-24.

Sponsored by Arkansas Children's Hospital Research Institute · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Enrolling by invitation — may be out of date.

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 253
Ages: 1 Year to 18 Years
Sex: All

Study 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.

Conditions studied

Acetaminophen Toxicity

Keywords

Acetaminophen
APAP

In context

Lead sponsor

Arkansas Children's Hospital Research Institute is the lead sponsor of 118 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Year to 18 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

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

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

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

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 253 participants (estimated)

Groups and cohorts

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

Study locations

8 sites

Arkansas Children's Hospital
Little Rock, Arkansas 72202, United States
Children's National Medical Center
Washington, District of Columbia 20010, United States
Kosair Charities Pediatric Clinical Research Unit University of Louisville
Louisville, Kentucky 40202, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108, United States
Akron Children's Research Center
Akron, Ohio 44308, United States
University of Toledo Health Science Center
Toledo, Ohio, United States
Cook's Children's Health System
Fort Worth, Texas 76104, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas 77030, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01005173
Lead sponsor: Arkansas Children's Hospital Research Institute
Collaborators: National Institutes of Health (NIH)
Responsible party: Sponsor
First posted: Oct 30, 2009
Start date: Aug 2009
Primary completion: Jun 2018 (estimated)
Last update: Nov 24, 2017

Study contacts

Laura P James, MD

principal investigator · Arkansas Children's Hospital Research Institute

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Arkansas Children's Hospital Research Institute

Start the discussion