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 : Recruiting
First Posted : September 23, 2016
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acetaminophen Exposure||Drug: Acetaminophen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||September 2020|
Subjects will take extra strength acetaminophen (4g/day) for the three days prior to the embolization procedure.
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.
- 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
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
|Contact: Clinical Research Coordinator||303-389-1800||Clinical.Trials@rmpdc.org|
|United States, Colorado|
|University of Colorado Denver||Recruiting|
|Denver, Colorado, United States, 80045|
|Contact: Clinical Research Coordinator 303-389-1800 Clinical.Trials@rmpdc.org|
|Principal Investigator:||Kennon Heard, MD, PhD||University of Colorado, Denver|