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

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 12, 2022

Primary Completion Date

August 31, 2025

Study Completion Date

November 30, 2025

Conditions
AcetaminophenDrug OverdoseAcetaminophen OverdoseAcetaminophen PoisoningDrug-induced Liver InjuryLiver FailureLiver Toxicity
Interventions
DRUG

Intravenous infusion of N-acetylcysteine

If randomized to Control, the participant will receive only N-acetylcysteine. The dose will be determined by the site investigator. Typical continued infusion rate is 6.25 mg/kg/hr. The control drug (D5W) will be administered using the same schedule as fomepizole.

DRUG

Intravenous infusion of Fomepizole (4-MP)

If randomized to fomepizole, the proposed infusion schedule for fomepizole closely mirrors the dosing outlined in the medication's package insert. Specifically, the Antizol (fomepizole) doses (bags) #1-5 allocated for the study will precisely adhere to the manufacturer's recommendations from the package insert. This entails an initial loading dose of 15 mg/kg followed by four subsequent doses of 10 mg/kg. The dose of fomepizole will not be adjusted based on age, presence of liver injury or renal insufficiency.

Trial Locations (1)

80204

RECRUITING

Denver Health and Hospital Authority, Denver

All Listed Sponsors
collaborator

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

INDUSTRY

lead

Richard Dart, MD, PhD

OTHER