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Serum Acetaminophen-Cystein (APAP-CYS) Adduct Concentrations in Subjects Expected to Develop Aminotransferase Elevations with Liver-Directed Therapy Intended to Treat Hepatic Tumors

Primary Objective

To describe serum acetaminophen-cysteine adduct (an experimental biomarker of acetaminophen exposure) concentrations following hepatic embolization in patients taking therapeutic doses of acetaminophen three days before the procedure

Study category: Cancer

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Description

This study aims to describe protein adduct (an experimental biomarker of acetaminophen exposure) concentrations in patients taking therapeutic doses of acetaminophen who develop a liver injury from a cause other than acetaminophen.

Details
Age

Adult

Eligibility

Adult patients undergoing portal vein or bland embolization for the treatment of metastatic liver tumor; no known hypersensitivity or allergy to acetaminophen

Detailed Eligibility: Patients are not eligible with: known cirrhosis; history of moderate to severe anemia; currently taking warfarin, isoniazid, and disulfiram; weigh less than or equal to 50kg, pregnant or breastfeeding, and currently enrolled in a clinical trial

Phase

IV - Research Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug's safety, efficacy, or optimal use.

Type of Study

Basic Science

Scope

Local

Locations

Denver Health Medical Center
University of Colorado Hospital

Principal Investigator
Kennon Heard,  MD

Kennon Heard, MD

Study ID

Protocol Number: 16-0031

ClinicalTrials.gov: NCT02911961

Categories

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