Acetaminophen Biomarkers

Status:	Enrolling by invitation
Healthy:	No
Age Range:	1 - 18
Updated:	11/25/2017
Start Date:	August 2009

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.

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

We found this trial at

sites

Childrens National Medical Center

111 Michigan Ave NW
Washington, District of Columbia

(202) 476-5000