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• Status: Withdrawn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