Overview

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

Status:
Withdrawn
Trial end date:
2021-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Denver Health and Hospital Authority
Collaborators:
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Rocky Mountain Poison and Drug Center
University of Colorado, Denver
Treatments:
Acetaminophen
Criteria
Inclusion Criteria:

- Subjects of any gender or ethnic background who are between 21 and 80 years old

- Subjects who are able to provide written, informed consent

- Subjects with secondary liver cancer

- Subjects undergoing portal vein or bland embolization for the treatment of secondary
hepatic tumor

- Subjects who are willing to have their blood drawn at least 12 times for study
purposes

- Subjects who agree to stay for ~18-21 hours after being discharged from the Department
of Radiology for research purposes

- Subjects who agree to refrain from using acetaminophen, other than the study drug,
during the dosing phase through a minimum of 5 days post-procedure

- Subjects who agree to consume less than 3 alcoholic drinks per day while taking study
drug (acetaminophen group only)

- Subjects who are willing to complete a study diary for 3 days prior to and the day of
the procedure

- Subjects who will be in the Denver metro area for the duration of the study

Exclusion Criteria:

- Subjects with known cirrhosis

- Subjects with a history of moderate to severe anemia at screening as defined by:

1. Moderate: Hemoglobin 8-9.5 g/dL

2. Severe: Hemoglobin <8 g/dL

- Subjects with an ALT or AST greater than 200 IU/L at screening

- Subjects with a total bilirubin greater than 1.5 mg/dL at screening

- Subjects with an INR greater than 1.3 at screening

- Subjects with a platelet count less than 125 10^9/L at screening

- Subjects who are currently taking warfarin (acetaminophen group only)

- Subjects with anorexia nervosa (self-reported; acetaminophen group only)

- Subjects who weigh ≤50 kg at screening (acetaminophen group only)

- Subjects who adhere to a fasting type diet (self-reported; acetaminophen group only)

- Subjects with a known hypersensitivity or allergy to acetaminophen (acetaminophen
group only)

- Subjects who are currently taking isoniazid (acetaminophen group only)

- Subjects who are currently taking disulfiram (acetaminophen group only)

- Subjects who are pregnant or breastfeeding (female participants only)

- Subjects who are currently enrolled in a clinical trial, have participated in a
clinical trial within the 30 days prior to the procedure, or who plan to participate
in a clinical trial during the 5 day post-procedure follow-up period