Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose (NCT05517668) | Clinical Trial Compass
TerminatedPhase 2
Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose
Stopped: Futility
United States29 participantsStarted 2022-09-12
Plain-language summary
This study is a randomized, placebo-controlled double-blinded clinical trial of patients presenting with acetaminophen poisoning who are at increased risk of developing liver injury. With this trial the investigators are hoping to show the superiority of acetylcysteine (NAC) + fomepizole (4-MP) compared to treatment with acetylcysteine alone. The primary objective of this trial is to determine the effect of fomepizole on the severity of acute liver injury in patients with acetaminophen poisoning.
Who can participate
Age range10 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Evidence of acute or repeated supratherapeutic ingestion (RSTI)\* of acetaminophen (serum acetaminophen greater or equal to 10 mg/L) after correction for bilirubin, when applicable\*\*
✓. Baseline AT Multiplication Product at screening (\[APAP\] multiplied by the serum AST or ALT in IU/L, whichever is higher) of 3000 or higher
✓. Adults and children ages 10 years or older
✓. Infusion of NAC started 8 hours or more post-ingestion
✓. Infusion of the study medication begins as early as possible but not later than 24 hours after the initiation of the NAC infusion.
✓. Patient presenting to or transferred to the participating site hospital and planned to be admitted to hospital for treatment and/or observation or treatment in Emergency Department
✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with mandatory study procedures and availability for the duration of the study
Exclusion criteria
What they're measuring
1
Difference in serum alanine transaminase (ALT) from presentation to peak recorded ALT
Timeframe: ALT will be measured at baseline, then at 12, 20, 32, 44, etc. hours after starting NAC (and every 12 hours afterwards) as long as patient is receiving medication (either NAC or NAC and 4-MP), two to three days on average.
✕. Serum ALT greater than 10,000 IU/L or serum AST greater than 20,000 IU/L at time of screening
✕. Another overdose episode with acetaminophen within the preceding 14 days
✕. Baseline ALT (defined as average of ALTs reported in preceding 12 months) above the ALT reference range for the hospital laboratory unless screening ALT is at least twice the patient's baseline value.
✕. Evidence of chronic decompensated liver cirrhosis regardless of serum ALT activity\*\*\*
✕. Known allergic reaction to acetylcysteine or a documented serious hypersensitivity reaction to fomepizole or other pyrazoles.
✕. Pregnancy or lactation
✕. Co-ingestion of other known activators or inhibitors of CYP2E1 (acetone, cimetidine, nicotine, isoniazid, pyridine, pyrazole, disulfiram). History of cigarette smoking, use of nicotine patches are allowed.
✕. Concomitant ingestion of high dosage iron preparations (e.g., prenatal iron sulfate capsules)