Specified Drug-use Survey of Fomepizole Intravenous Infusion (All-case Surveillance)

Study Overview
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Brief Summary
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The objective of this survey is to evaluate the safety and efficacy of fomepizole intravenous infusion in Japanese patients with ethylene glycol and methanol poisonings in daily medical practice.

Detailed Description
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Clinical studies for fomepizole intravenous infusion have not been conducted in Japan, and there are few reports of data on drug-use, including in the literature, in Japanese patients; therefore, an evaluation of the safety and efficacy of fomepizole intravenous infusion is required. This specified drug-use survey for fomepizole intravenous infusion (Fomepizole Intravenous Infusion 1.5 g Takeda, hereinafter referred to as the drug) was planned to evaluate the safety and efficacy of the drug in patients with ethylene glycol and methanol poisoning in daily medical practice.

Official Title
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Specified Drug-use Survey of Fomepizole Intravenous Infusion Takeda (All-case Surveillance)

Conditions
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Ethylene Glycol Poisoning, Methanol Poisoning

Intervention / Treatment
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* Drug: Fomepizole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -All patients who have been confirmed as receiving the drug Exclusion Criteria: -None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fomepizole Intravenous Infusion<br>Fomepizole Intravenous Infusion | Drug: Fomepizole<br>* The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.<br>* Other names: Fomepizole Intravenous Infusion 1.5 g;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequencies of adverse events | The frequencies of all adverse reactions observed during the observation period will be tabulated by symptom, day of onset, and severity. An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; an abnormal exacerbation of the target disease (an unexpected exacerbation other than the natural course of the target disease) is also defined as an adverse event; however, an expected exacerbation of the target disease is not considered an adverse event. | Participants will be followed from the first dose of the drug to 24 hours after the last dose of the drug, an expected average of 3 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in arterial blood pH | Summary statistics for arterial blood pH values and the changes from baseline will be calculated at each time point. | Participants will be followed from the first dose of the drug to 24 hours after the last dose of the drug, an expected average of 3 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacotherapy