Trial · NCT05517668
Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose
NCT05517668, Phase 2, Terminated, Richard Dart, MD, PhD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose. Trials, record NCT05517668. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05517668
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose
- NCT number
- NCT05517668
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Richard Dart, MD, PhD
- Conditions
- Acetaminophen, Drug Overdose, Acetaminophen Overdose, Acetaminophen Poisoning, Drug-induced Liver Injury, Liver Failure, Liver Toxicity
- Interventions
- Intravenous infusion of N-acetylcysteine, Intravenous infusion of Fomepizole (4-MP)
- First posted
- 2022-08-26
- Last updated
- 2025-11-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in serum alanine transaminase (ALT) from presentation to peak recorded ALT | ALT will be measured at baseline, then at 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. | Determine the effect of fomepizole on the severity of acute liver injury in patients with acetaminophen ingestion. Serum ALT is a recognized measure of liver injury. A smaller increase in ALT indicates the efficacy of the study drug. |
| Secondary | Time to meet endpoints for termination of acetylcysteine infusion | Study participants will be evaluated for study medication discontinuation at 12, 20, 32, 44, etc. hours after starting NAC (every 12 hours afterwards) as long as patient is receiving medication (either NAC or NAC and 4-MP), two to three days on average. | Determine effect on clinical practice. Shorter time to endpoint indicates improved efficacy compared to treatment with acetylcysteine alone. |
| Secondary | Peak INR | INR will be measured at baseline, then at 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. | Determine the effect of fomepizole on other measures of liver injury and acute liver failure. INR is a measure of hepatic function. |
| Secondary | Peak aspartate aminotransferase (AST) | AST will be measured at baseline then at 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. | Determine the effect of fomepizole on other measures of liver injury and acute liver failure. AST is a measure of hepatic injury. |
| Secondary | Peak creatinine | Creatinine will be measured at baseline then at 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. | Determine the effect of fomepizole on measures of kidney injury. Creatinine is a measure of kidney injury. |
| Secondary | Measurement of protein adducts | 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. | Assess contribution of CYP2E1 inhibition by fomepizole effect, if any. Decreased protein adduct concentration in blood indicates fomepizole has blocked CYP2E1. |
| Secondary | Proportion of patients developing acute liver failure (ALF). | INR, ALT and AST will be measured at baseline, then at 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. | Assess overall incidence of acute liver failure (ALF). |
| Secondary | Serial measurement of fomepizole serum concentration | 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. | Assess pharmacokinetic profile of fomepizole. Assess whether continuous infusion produces steady concentration. |
| Other | Measurement to perform a candidate gene analysis of CYP2E1, glutathione synthetase, UDP-glucuronosyltransferases, JNK related to APAP toxicity. | Pharmacogenomics will be measured at 5 hours after study subject starts receiving NAC. | Determine genetic variants of acetaminophen overdose and response to treatment |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37681263 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05517668
GET https://conductscience.org/api/trials/v1/NCT05517668/registered