Acetaminophen Biomarkers

Status unconfirmed

Conditions studied: Acetaminophen Toxicity

In brief

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.

Key facts

Study ID

NCT01005173

Run by

Arkansas Children's Hospital Research Institute

People needed

253

Starts

2009-08-01

Last updated by the study team

2017-11-24

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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