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

NCT02911961

WithdrawnPhase 4

Sponsor: Denver Health and Hospital Authority

Conditions: Acetaminophen Exposure

Interventions: Acetaminophen

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 21 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Denver, Colorado, United States