Acetaminophen Biomarkers

November 21, 2017 updated by: Arkansas Children's Hospital Research Institute

Identification of New Mechanistic Biomarkers of Adverse Response to Acetaminophen

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

253

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Laura P James, MD, Arkansas Children's Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

October 28, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

October 30, 2009

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R01DK081406-01A1 (U.S. NIH Grant/Contract)
  • 1 R01 DK081406-01A1 - NIH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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