APAP-CYS Protein Adduct Concentrations in Patients With Liver-Directed Therapy Intended to Treat Hepatic Tumors
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ClinicalTrials.gov Identifier: NCT02911961 |
Recruitment Status :
Withdrawn
(Due to lack of enrollment and organizational desire to focus recruitment efforts on other studies.)
First Posted : September 23, 2016
Last Update Posted : September 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acetaminophen Exposure | Drug: Acetaminophen | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Serum Acetaminophen-Cysteine (APAP-CYS) Adduct Concentrations in Subjects Expected to Develop Aminotransferase Elevations With Liver-Directed Therapy Intended to Treat Hepatic Tumors |
Estimated Study Start Date : | August 2021 |
Estimated Primary Completion Date : | August 2021 |
Estimated Study Completion Date : | August 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Acetaminophen
Subjects will take extra strength acetaminophen (4g/day) for the three days prior to the embolization procedure.
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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.
Other Name: Tylenol |
No Intervention: Observational - No Acetaminophen
Subjects will take no acetaminophen containing products prior to the embolization procedure.
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- APAP-CYS Concentrations Over Time - Acetaminophen Group [ Time Frame: 14 days ]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
- APAP-CYS Concentrations Over Time - Non-Acetaminophen Group [ Time Frame: 2 years ]To determine if subjects who report no exposure to acetaminophen prior to the procedure have detectable APAP-CYS concentrations
- Relationship between APAP-CYS and other biochemical markers of liver function [ Time Frame: 2 years ]To evaluate the relationship between APAP-CYS concentrations with aspartate aminotransferase (AST), alanine aminotransferase (ALT), and miRNA activity

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Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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)
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911961
United States, Colorado | |
University of Colorado Denver | |
Denver, Colorado, United States, 80045 |
Principal Investigator: | Kennon Heard, MD, PhD | University of Colorado, Denver |
Responsible Party: | Kennon Heard, Principal Investigator, Denver Health and Hospital Authority |
ClinicalTrials.gov Identifier: | NCT02911961 |
Other Study ID Numbers: |
16-0031 |
First Posted: | September 23, 2016 Key Record Dates |
Last Update Posted: | September 2, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Acetaminophen |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics |