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.
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
8
sites
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Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Louisville, Kentucky 40202
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111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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