Ignite Creation Date:
2025-12-18 @ 8:31 AM
Ignite Modification Date:
2025-12-23 @ 11:09 PM
Study NCT ID:
NCT02415712
Status:
None
Last Update Posted:
2024-03-04 00:00:00
First Post:
2015-03-24 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Specified Drug-use Survey of Fomepizole Intravenous Infusion (All-case Surveillance)
Sponsor:
None
Organization:
Study Overview
Official Title:
Specified Drug-use Survey of Fomepizole Intravenous Infusion "Takeda" (All-case Surveillance)
Status:
None
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: