Fomepizole for Acetaminophen Overdose

Phase 2

Recruiting

Research Sponsored by Richard Dart, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up fomepizole serum concentration will be measured at 2, 5, 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a combo of two drugs can help prevent liver injury in acetaminophen poisoning. Primary goal is to measure effect of one drug on severity of injury.

Who is the study for?

This trial is for people aged 10 or older who have taken too much acetaminophen and are at risk of liver injury. They must have a certain level of acetaminophen in their blood and be admitted to the hospital. Pregnant women, those with severe liver damage, recent seizures, heart issues, or other serious health problems can't join.

What is being tested?

The study tests if adding Fomepizole (4-MP) to the standard treatment with N-acetylcysteine (NAC) is better for treating acetaminophen overdose than using NAC alone. Participants will receive either both drugs or just NAC through an IV in this randomized and blinded trial.

What are the potential side effects?

Possible side effects include allergic reactions to the medications used, irritation at the infusion site, headache, dizziness, nausea, changes in blood pressure or heart rate. The severity of side effects may vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ protein adducts will be measured at 2, 5, 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~protein adducts will be measured at 2, 5, 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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and protein adducts will be measured at 2, 5, 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in serum ALT from presentation to peak recorded ALT

Secondary study objectives

Measurement of protein adducts

Peak AST

International Normalized Ratio

+4 more

Other study objectives

Measurement to perform a candidate gene analysis of CYP2E1, glutathione synthetase, UDP-glucuronosyltransferases, JNK related to APAP toxicity.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: N-acetylcysteine (NAC) and Fomepizole (4-MP) (Study)Experimental Treatment2 Interventions

Patients randomized to Study group will receive fomepizole (diluted in D5W) in addition to N-acetylcysteine. Study participants will receive study drug (fomepizole or placebo) throughout the study. If randomized to Study group, the infusion of the study medication should be initiated as soon as feasible but no later than 24 hours after the commencement of acetylcysteine therapy.

Group II: N-acetylcysteine (NAC) only (Control)Active Control1 Intervention

Patients randomized to Control group will receive placebo (D5W) in addition to N-acetylcysteine. Study participants will receive study drug (fomepizole or placebo) throughout the study.

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