Acetaminophen-Protein Adduct Resolution (AR)

Denver Health and Hospital Authority

Status: Completed

Conditions: Acetaminophen-protein Adduct Formation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01021410

COMIRB 09-0510

Details and patient eligibility

About

The purpose of this study is to better understand the pharmacokinetics of acetaminophen and further clinical interpretations of laboratory results that confirm the presence of acetaminophen-cys adducts. This study will determine how long adducts persist in serum after a therapeutic course of acetaminophen as taken in a previous study (COMIRB 06-1265). Subjects will be asked to complete three study visits, each three days apart, following termination of COMIRB 06-1265. Each study visit will include collection of blood samples for batch testing of aminotransferase, serum acetaminophen and protein adducts. No interventions are planned.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any subject randomized to the acetaminophen arm of COMIRB 06-1265 and meets completion criteria

Exclusion criteria

• Subjects who enter the extended dosing period in protocol 06-1265.
• Subjects who were randomized to placebo.

Trial design

100 participants in 1 patient group

Acetaminophen Group

Description:

Subjects who completed COMIRB 06-1265 and were assigned to the acetaminophen treatment group for that study.