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

Overview

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.

Full Title of Study: “Specified Drug-use Survey of Fomepizole Intravenous Infusion “Takeda” (All-case Surveillance)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2022

Detailed Description

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.

Interventions

  • Drug: Fomepizole
    • 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.

Arms, Groups and Cohorts

  • Fomepizole Intravenous Infusion
    • Fomepizole Intravenous Infusion

Clinical Trial Outcome Measures

Primary Measures

  • Frequencies of adverse events
    • Time Frame: 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.
    • 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.

Secondary Measures

  • Change from baseline in arterial blood pH
    • Time Frame: 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.
    • Summary statistics for arterial blood pH values and the changes from baseline will be calculated at each time point.

Participating in This Clinical Trial

Inclusion Criteria

  • All patients who have been confirmed as receiving the drug

Exclusion Criteria

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Takeda
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Postmarketing Group Manager, Study Director, Takeda
  • Overall Contact(s)
    • Takeda Study Registration Call Center, +1-877-825-3327, medicalinformation@tpna.com

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