Acetaminophen Biomarkers

Acetaminophen Toxicity Clinical Trial

Official title:

Identification of New Mechanistic Biomarkers of Adverse Response to Acetaminophen

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01005173
• Other study ID #: 1R01DK081406-01A1
• Secondary ID: 1 R01 DK081406-0
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 28, 2009
• Last updated: November 21, 2017
• Start date: August 2009

Study information

• Verified date: November 2017
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 253
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acetaminophen Toxicity

Locations

Country	Name	City	State
United States	Akron Children's Research Center	Akron	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	Children's Mercy Hospitals and Clinics	Kansas City	Missouri
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Kosair Charities Pediatric Clinical Research Unit University of Louisville	Louisville	Kentucky
United States	University of Toledo Health Science Center	Toledo	Ohio
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States,