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N-acetylcysteine (NAC) and Fomepizole (4-MP) (Study) for Acetaminophen Overdose

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Acetaminophen Overdose+6 MoreIntravenous infusion of Fomepizole (4-MP) - Drug
Eligibility
18 - 99
All Sexes
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Study 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.

Eligible Conditions
  • Acetaminophen Overdose
  • Acetaminophen
  • Drug Overdose
  • Liver toxicity
  • Drug-induced Liver Injury
  • Liver Failure

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 10 Secondary · Reporting Duration: 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.

Hour 12
Difference in serum ALT from presentation to peak recorded ALT
Mean difference in serum ALT from presentation to peak recorded ALT
Hour 12
Mean peak AST
Peak AST
Hour 12
Mean peak creatinine
Creatinine
Hour 12
Serial measurement of fomepizole serum concentration
Hour 12
Mean peak INR
International Normalized Ratio
Hour 12
Proportion of patients developing acute liver failure (ALF).
Hour 5
Measurement to perform a candidate gene analysis of CYP2E1, glutathione synthetase, UDP-glucuronosyltransferases, JNK related to APAP toxicity.
Hour 12
Measurement of protein adducts
Hour 12
Time to meet endpoints for termination of acetylcysteine infusion

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Trial Design

2 Treatment Groups

N-acetylcysteine (NAC) only (Control)
1 of 2
N-acetylcysteine (NAC) and Fomepizole (4-MP) (Study)
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: N-acetylcysteine (NAC) and Fomepizole (4-MP) (Study) · No Placebo Group · Phase 2

N-acetylcysteine (NAC) and Fomepizole (4-MP) (Study)Experimental Group · 2 Interventions: Intravenous infusion of Fomepizole (4-MP), Intravenous infusion of N-acetylcysteine · Intervention Types: Drug, Drug
N-acetylcysteine (NAC) only (Control)
Drug
ActiveComparator Group · 1 Intervention: Intravenous infusion of N-acetylcysteine · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

Richard Dart, MD, PhDLead Sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionIndustry Sponsor
8 Previous Clinical Trials
2,425 Total Patients Enrolled

Eligibility Criteria

Age 18 - 99 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a baseline serum AST or ALT level of 1500 or higher.
You are willing to comply with the study's requirements and are available for the duration of the study.
References

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