Acetaminophen Biomarkers

NCT01005173 | Unknown

• 2 other identifiers: 1R01DK081406-01A11 R01 DK081406-01A1 - NIH
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Acetaminophen Toxicity

Keywords

Acetaminophen; APAP

Study Arms (3)

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

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead
• National Institutes of Health (NIH): collaborator

Study Sites (8)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Kosair Charities Pediatric Clinical Research Unit University of Louisville

Louisville, Kentucky, 40202, United States

Location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

Akron Children's Research Center

Akron, Ohio, 44308, United States

Location

University of Toledo Health Science Center

Toledo, Ohio, United States

Location

Cook's Children's Health System

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine - Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Study Officials

• Laura P James, MD

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 30, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2018
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

US (8)