A Randomized Controlled Study to Evaluate the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose
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.
• 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