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

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

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.

Study Overview

• Status: Completed
• Conditions: Ethylene Glycol Poisoning, Methanol Poisoning
• Intervention / Treatment: Drug: Fomepizole

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.

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Takeda Sponsored Site
  • Tokyo, Japan
    • Takeda Sponsored Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Ethylene glycol poisoning or methanol poisoning

Description

Inclusion Criteria:

-All patients who have been confirmed as receiving the drug

Exclusion Criteria:

-None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fomepizole Intravenous Infusion	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.; Other Names: Fomepizole Intravenous Infusion 1.5 g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting One or More Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
Number of Participants Who Had One or More Adverse Drug Reactions	An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.	From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
Number of Participants Reporting One or More Serious Adverse Events (SAEs)	A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.	From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
Number of Participants Who Had One or More Serious Adverse Drug Reactions	A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Serious adverse drug reaction refers to serious AE that are related to administered drug.	From the first dose to 24 hours after the last dose of the drug (Up to approximately 11 days)
Arterial Blood pH	pH in arterial blood values at baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 days) were reported.	Baseline, 4 hours after the first dose, and 24 hours after the last dose (Up to approximately 11 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.

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2015
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimated): April 14, 2015

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacotherapy
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protective Agents; Antidotes; Fomepizole
• Other Study ID Numbers: Fomepizole-5001; jRCT1080222765 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No