APAP-CYS Protein Adduct Concentrations in Patients With Liver-Directed Therapy Intended to Treat Hepatic Tumors
Withdrawn before enrolling · Phase 4
Conditions studied: Acetaminophen Exposure
In brief
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.
Key facts
- Study ID
- NCT02911961
- Run by
- Denver Health and Hospital Authority
- People needed
- 0
- Starts
- 2021-08-01
- Expected to finish
- 2021-08-01
- Last updated by the study team
- 2021-09-02
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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)
- 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
Where it is running
- University of Colorado Denver — Denver, Colorado, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.