Clinical trial · Interventional
APAP-CYS Protein Adduct Concentrations in Patients With Liver-Directed Therapy Intended to Treat Hepatic Tumors
Serum Acetaminophen-Cysteine (APAP-CYS) Adduct Concentrations in Subjects Expected to Develop Aminotransferase Elevations With Liver-Directed Therapy Intended to Treat Hepatic Tumors
NCT02911961CI-TRIAL-00053655withdrawnPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to lack of enrollment and organizational desire to focus recruitment efforts on other studies.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acetaminophen Exposure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acetaminophen
- description
- Subjects will take extra strength acetaminophen (4g/day) for the three days prior to the embolization procedure.
- interventionNames
- Drug: Acetaminophen
- type
- NO_INTERVENTION
- label
- Observational - No Acetaminophen
- description
- Subjects will take no acetaminophen containing products prior to the embolization procedure.
Primary outcomes (1)
- measure
- APAP-CYS Concentrations Over Time - Acetaminophen Group
- timeFrame
- 14 days
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.