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APAP-CYS Protein Adduct Concentrations in Patients With Liver-Directed Therapy Intended to Treat Hepatic Tumors

NCT02911961 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2021-09-02

No results posted yet for this study

Summary

The objective of this study is to provide preliminary data to describe serum acetaminophen-cysteine protein adduct (APAP-CYS) concentrations following therapeutic doses of acetaminophen in the setting of non-acetaminophen induced liver injury. This study will utilize hepatic embolization as a model of hepatic injury.

Conditions

  • Acetaminophen Exposure

Interventions

DRUG

Acetaminophen

1 gram acetaminophen 4 times a day with at least 6 hour intervals between doses for the 3 days prior to the embolization procedure.

Sponsors & Collaborators

  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

    collaborator INDUSTRY

  • University of Colorado, Denver

    collaborator OTHER

  • Rocky Mountain Poison and Drug Center

    collaborator UNKNOWN

  • Denver Health and Hospital Authority

    lead OTHER

Principal Investigators

  • Kennon Heard, MD, PhD · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2021-08-31
Completion
2021-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02911961 on ClinicalTrials.gov