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

NCT02911961 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 16-0031
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• APAP-CYS Concentrations Over Time - Acetaminophen Group

  To describe the course of APAP-CYS concentrations following hepatic embolization in subjects who receive 4 grams/day of acetaminophen for three days prior to the procedure

  14 days

Secondary Outcomes (2)

• APAP-CYS Concentrations Over Time - Non-Acetaminophen Group

  2 years

• Relationship between APAP-CYS and other biochemical markers of liver function

  2 years

Study Arms (2)

Acetaminophen

EXPERIMENTAL

Subjects will take extra strength acetaminophen (4g/day) for the three days prior to the embolization procedure.

Drug: Acetaminophen

Observational - No Acetaminophen

NO INTERVENTION

Subjects will take no acetaminophen containing products prior to the embolization procedure.

Interventions

Acetaminophen DRUG

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

Also known as: Tylenol

Acetaminophen

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects with known cirrhosis
• Subjects with a history of moderate to severe anemia at screening as defined by:
• Moderate: Hemoglobin 8-9.5 g/dL
• 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)

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division: collaborator
• University of Colorado, Denver: collaborator
• Rocky Mountain Poison and Drug Center: collaborator

Study Sites (1)

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Kennon Heard, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: September 23, 2016
• Study Start: August 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)