Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose

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.

Timeline

Start

2022-09-12

Primary completion

2025-10-31

Completion

2025-11-08

Publications

• Pepin L, Matsler N, Fontes A, Heard K, Flaherty BF, Monte AA. Fomepizole Therapy for Acetaminophen-Induced Liver Failure in an Infant. Pediatrics. 2023 Oct 1;152(4):e2022061033. doi: 10.1542/peds.2022-061033.

Drugs

Indications